The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis (OPPORTUNITY)

January 23, 2017 updated by: Novo Nordisk A/S

Efficacy and Safety of Somatropin in Adult Patients on Chronic Haemodialysis

This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.

The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The decision to discontinue the trial is not due to safety concerns. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is expected to have a negative impact on the outcome of the trial.

Study Type

Interventional

Enrollment (Actual)

712

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1636DSU
        • Novo Nordisk Investigational Site
      • Buenos Aires, Argentina, C1181ACH
        • Novo Nordisk Investigational Site
      • Capital Federal, Argentina, C1425BPM
        • Novo Nordisk Investigational Site
      • Capital Federal, Argentina, C1431FWO
        • Novo Nordisk Investigational Site
      • Cordoba, Argentina, X5002HWE
        • Novo Nordisk Investigational Site
      • Morón, Argentina, B1708DPO
        • Novo Nordisk Investigational Site
      • Pergamino, Argentina, B2700CPM
        • Novo Nordisk Investigational Site
      • San Miguel de Tucuman, Argentina, 4000
        • Novo Nordisk Investigational Site
      • Sarandí, Argentina, B1872EEA
        • Novo Nordisk Investigational Site
      • Temperley, Argentina, 1834
        • Novo Nordisk Investigational Site
  • Brazil
      • Curitiba, Brazil, 81050-090
        • Novo Nordisk Investigational Site
      • Fortaleza, Brazil, 60336-550
        • Novo Nordisk Investigational Site
      • Fortaleza, Brazil, 60430-370
        • Novo Nordisk Investigational Site
      • Jaboatao de Guararapes, Brazil, 54400-170
        • Novo Nordisk Investigational Site
      • Porto Alegre, Brazil, 90035-903
        • Novo Nordisk Investigational Site
      • Porto Alegre, Brazil, 90420090
        • Novo Nordisk Investigational Site
      • Porto Alegre, Brazil, 90610000
        • Novo Nordisk Investigational Site
      • Rio de Janeiro, Brazil, 22260-020
        • Novo Nordisk Investigational Site
      • Sorocaba, Brazil, 18030-083
        • Novo Nordisk Investigational Site
      • São José Rio Preto, Brazil, 15090-000
        • Novo Nordisk Investigational Site
      • São Paulo, Brazil, 04039001
        • Novo Nordisk Investigational Site
  • Canada
      • Greenfield Park, Canada, J4V 2H1
        • Novo Nordisk Investigational Site
      • London, Canada, N6A 5A5
        • Novo Nordisk Investigational Site
      • Peterborough, Canada, K9J 7C6
        • Novo Nordisk Investigational Site
      • Regina, Canada, S4P 0W5
        • Novo Nordisk Investigational Site
      • Saskatoon, Canada, S7M 2Z1
        • Novo Nordisk Investigational Site
      • Scarborough, Canada, M1H 3G4
        • Novo Nordisk Investigational Site
      • Thunder Bay, Canada, P7B 6V4
        • Novo Nordisk Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Novo Nordisk Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Novo Nordisk Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Novo Nordisk Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, HIT 2M4
        • Novo Nordisk Investigational Site
  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100050
        • Novo Nordisk Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Novo Nordisk Investigational Site
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Novo Nordisk Investigational Site
  • Denmark
      • Arhus N, Denmark, 8200
        • Novo Nordisk Investigational Site
      • Copenhagen, Denmark, 2100
        • Novo Nordisk Investigational Site
      • Herlev, Denmark, 2730
        • Novo Nordisk Investigational Site
      • Hilleroed, Denmark, 3400
        • Novo Nordisk Investigational Site
      • Holbaek, Denmark, 4300
        • Novo Nordisk Investigational Site
      • Odense, Denmark, 5000
        • Novo Nordisk Investigational Site
      • Ålborg, Denmark, 9100
        • Novo Nordisk Investigational Site
  • France
      • Beziers, France, 34500
        • Novo Nordisk Investigational Site
      • Bordeaux, France, 33000
        • Novo Nordisk Investigational Site
      • Bordeaux Cedex, France, 33076
        • Novo Nordisk Investigational Site
      • Cherbourt-Octeville, France, 50102
        • Novo Nordisk Investigational Site
      • Clermont-Ferrand, France, 63000
        • Novo Nordisk Investigational Site
      • Dunkerque, France, 59385
        • Novo Nordisk Investigational Site
      • Lyon Cedex 3, France, 69437
        • Novo Nordisk Investigational Site
      • Montpellier Cedex 5, France, 34295
        • Novo Nordisk Investigational Site
      • Muret Cedex, France, 31603
        • Novo Nordisk Investigational Site
      • Nantes Cedex 1, France, 44093
        • Novo Nordisk Investigational Site
      • Paris, France, 75015
        • Novo Nordisk Investigational Site
      • Paris, France, 75013
        • Novo Nordisk Investigational Site
      • Paris, France, 75016
        • Novo Nordisk Investigational Site
      • Paris, France, 75018
        • Novo Nordisk Investigational Site
      • Poissy, France, 78300
        • Novo Nordisk Investigational Site
      • Trappes, France, 78190
        • Novo Nordisk Investigational Site
      • Vichy, France, 3209
        • Novo Nordisk Investigational Site
  • Germany
      • Aschaffenburg, Germany, 63741
        • Novo Nordisk Investigational Site
      • Bad Mergentheim, Germany, 97980
        • Novo Nordisk Investigational Site
      • Bamberg, Germany, 96049
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 10117
        • Novo Nordisk Investigational Site
      • Bernkastel-Kues, Germany, 54470
        • Novo Nordisk Investigational Site
      • Bottrop, Germany, 46242
        • Novo Nordisk Investigational Site
      • Dormagen, Germany, 41539
        • Novo Nordisk Investigational Site
      • Düsseldorf, Germany, 40210
        • Novo Nordisk Investigational Site
      • Elsenfeld, Germany, 63820
        • Novo Nordisk Investigational Site
      • Fürstenzell, Germany, 94081
        • Novo Nordisk Investigational Site
      • Gütersloh, Germany, 33332
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22297
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22767
        • Novo Nordisk Investigational Site
      • Hannover, Germany, 30625
        • Novo Nordisk Investigational Site
      • Heilbronn, Germany, 74076
        • Novo Nordisk Investigational Site
      • Kiel, Germany, 24106
        • Novo Nordisk Investigational Site
      • Krefeld, Germany, 47798
        • Novo Nordisk Investigational Site
      • Limburg an der Lahn, Germany, 65549
        • Novo Nordisk Investigational Site
      • Lüdenscheid, Germany, 58515
        • Novo Nordisk Investigational Site
      • Mettmann, Germany, 40822
        • Novo Nordisk Investigational Site
      • Minden, Germany, 32425
        • Novo Nordisk Investigational Site
      • Nettetal, Germany, 41334
        • Novo Nordisk Investigational Site
      • Passau, Germany, 94032
        • Novo Nordisk Investigational Site
      • Schweinfurt, Germany, 97421
        • Novo Nordisk Investigational Site
      • Straubing, Germany, 94315
        • Novo Nordisk Investigational Site
      • Würzburg, Germany, 97072
        • Novo Nordisk Investigational Site
      • Würzburg, Germany, 97080
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1083
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, 1097
        • Novo Nordisk Investigational Site
      • Eger, Hungary, 3300
        • Novo Nordisk Investigational Site
      • Kecskemet, Hungary, 6001
        • Novo Nordisk Investigational Site
      • Sopron, Hungary, 9400
        • Novo Nordisk Investigational Site
  • India
      • Hyderabad, India, 500034
        • Novo Nordisk Investigational Site
      • Pune, India, 411011
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500082
        • Novo Nordisk Investigational Site
  • Israel
      • Ashkelon, Israel, 78278
        • Novo Nordisk Investigational Site
      • Hadera, Israel, 38100
        • Novo Nordisk Investigational Site
      • Haifa, Israel, 34362
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel
        • Novo Nordisk Investigational Site
      • Petah-Tikva, Israel, 49100
        • Novo Nordisk Investigational Site
      • Rechovot, Israel
        • Novo Nordisk Investigational Site
      • Tzriffin, Israel, 70300
        • Novo Nordisk Investigational Site
  • Italy
      • Bologna, Italy, 40138
        • Novo Nordisk Investigational Site
      • Brescia, Italy, 23125
        • Novo Nordisk Investigational Site
      • Genova, Italy, 16132
        • Novo Nordisk Investigational Site
      • Milano, Italy, 20142
        • Novo Nordisk Investigational Site
      • Modena, Italy, 41100
        • Novo Nordisk Investigational Site
      • Pavia, Italy, 27100
        • Novo Nordisk Investigational Site
  • Poland
      • Kraków, Poland, 31-908
        • Novo Nordisk Investigational Site
      • Krasnik, Poland, 23-210
        • Novo Nordisk Investigational Site
      • Kwidzyn, Poland, 82-500
        • Novo Nordisk Investigational Site
      • Myslenice, Poland, 32-400
        • Novo Nordisk Investigational Site
      • Ostrów Mazowiecka, Poland, 07-300
        • Novo Nordisk Investigational Site
      • Poznann, Poland, 60-355
        • Novo Nordisk Investigational Site
      • Pulawy, Poland, 24-100
        • Novo Nordisk Investigational Site
      • Radom, Poland, 26-617
        • Novo Nordisk Investigational Site
      • Sieradz, Poland, 98-200
        • Novo Nordisk Investigational Site
      • Slupca, Poland, 63-400
        • Novo Nordisk Investigational Site
      • Sochaczew, Poland, 96-500
        • Novo Nordisk Investigational Site
      • Wejherowo, Poland, 84-200
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 51-124
        • Novo Nordisk Investigational Site
      • ul Mlynska 5, Poland, 33-300
        • Novo Nordisk Investigational Site
  • Portugal
      • Abrantes, Portugal, 2200-233
        • Novo Nordisk Investigational Site
      • Amadora, Portugal, 2700-473
        • Novo Nordisk Investigational Site
      • Braga, Portugal, 4710-391
        • Novo Nordisk Investigational Site
      • Corroios, Portugal, 2855-227
        • Novo Nordisk Investigational Site
      • Entroncamento, Portugal, 2330-108
        • Novo Nordisk Investigational Site
      • Setubal, Portugal, 2900-655
        • Novo Nordisk Investigational Site
      • Torres Vedras, Portugal, 2560-272
        • Novo Nordisk Investigational Site
      • Villa Franca de Xira, Portugal, 2600-076
        • Novo Nordisk Investigational Site
      • Villa Nova de Gaia, Portugal, 4430-196
        • Novo Nordisk Investigational Site
      • Évora, Portugal, 7000-711
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 125284
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 123182
        • Novo Nordisk Investigational Site
      • Petrozavodsk, Russian Federation, 185019
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 195257
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 197022
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 191015
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 191104
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 195067
        • Novo Nordisk Investigational Site
  • South Africa
      • Obervatory, South Africa, 7925
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2013
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 8029
        • Novo Nordisk Investigational Site
      • Burgos, Spain, 9006
        • Novo Nordisk Investigational Site
      • Cordoba, Spain, 14005
        • Novo Nordisk Investigational Site
      • Granollers, Spain, 8401
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28006
        • Novo Nordisk Investigational Site
      • Santander, Spain, 39001
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41013
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 96007
        • Novo Nordisk Investigational Site
  • Sweden
      • Stockholm, Sweden, 182 88
        • Novo Nordisk Investigational Site
      • Uppsala, Sweden, 751 85
        • Novo Nordisk Investigational Site
      • Värnamo, Sweden, 331 85
        • Novo Nordisk Investigational Site
  • Turkey
      • Ankara, Turkey, 06500
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34390
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34668
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34360
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Novo Nordisk Investigational Site
      • Birmingham, United Kingdom, B9 5ST
        • Novo Nordisk Investigational Site
      • Cambridge, United Kingdom, CB2 2QQ
        • Novo Nordisk Investigational Site
      • Coventry, United Kingdom, CV2 2DX
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G11 6NT
        • Novo Nordisk Investigational Site
      • Leicester, United Kingdom, LE5 4PW
        • Novo Nordisk Investigational Site
      • Liverpool, United Kingdom, L69 3GA
        • Novo Nordisk Investigational Site
      • London, United Kingdom, NW3 2QG
        • Novo Nordisk Investigational Site
      • Londonderry, United Kingdom, BT47 6SB
        • Novo Nordisk Investigational Site
      • Manchester, United Kingdom, M13 9WL
        • Novo Nordisk Investigational Site
      • Rhyl, United Kingdom, LL18 5UJ
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA6 6NL
        • Novo Nordisk Investigational Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Alexander City, Alabama, United States, 35010
        • Novo Nordisk Investigational Site
      • Birmingham, Alabama, United States, 35211
        • Novo Nordisk Investigational Site
      • Madison, Alabama, United States, 35758
        • Novo Nordisk Investigational Site
      • Mobile, Alabama, United States, 36617
        • Novo Nordisk Investigational Site
      • Mobile, Alabama, United States, 36608
        • Novo Nordisk Investigational Site
      • Montgomery, Alabama, United States, 36106
        • Novo Nordisk Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85012
        • Novo Nordisk Investigational Site
      • Tempe, Arizona, United States, 85284
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85719
        • Novo Nordisk Investigational Site
      • Tuscon, Arizona, United States, 85723
        • Novo Nordisk Investigational Site
    • Arkansas
      • Eldorado, Arkansas, United States, 71730
        • Novo Nordisk Investigational Site
      • Fort Smith, Arkansas, United States, 72901
        • Novo Nordisk Investigational Site
      • Hot Springs, Arkansas, United States, 71901
        • Novo Nordisk Investigational Site
      • Little Rock, Arkansas, United States, 72204
        • Novo Nordisk Investigational Site
      • McGehee, Arkansas, United States, 71654
        • Novo Nordisk Investigational Site
      • Paragould, Arkansas, United States, 72450
        • Novo Nordisk Investigational Site
      • Pine Bluff, Arkansas, United States, 71603
        • Novo Nordisk Investigational Site
    • California
      • Beverly Hills, California, United States, 90211
        • Novo Nordisk Investigational Site
      • Chula Vista, California, United States, 91910
        • Novo Nordisk Investigational Site
      • Covina, California, United States, 91723
        • Novo Nordisk Investigational Site
      • Escondido, California, United States, 92025
        • Novo Nordisk Investigational Site
      • Glendale, California, United States, 91205
        • Novo Nordisk Investigational Site
      • La Mesa, California, United States, 91942
        • Novo Nordisk Investigational Site
      • Lakewood, California, United States, 90712
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90822
        • Novo Nordisk Investigational Site
      • Los Alamitos, California, United States, 90720
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90017
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90095
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90033
        • Novo Nordisk Investigational Site
      • Lynwood, California, United States, 90262
        • Novo Nordisk Investigational Site
      • Merced, California, United States, 95340
        • Novo Nordisk Investigational Site
      • Mission Hills, California, United States, 91345
        • Novo Nordisk Investigational Site
      • Monterey Park, California, United States, 91745
        • Novo Nordisk Investigational Site
      • Mountain View, California, United States, 94041
        • Novo Nordisk Investigational Site
      • Pasadena, California, United States, 91106
        • Novo Nordisk Investigational Site
      • Porterville, California, United States, 93257
        • Novo Nordisk Investigational Site
      • Riverside, California, United States, 92505
        • Novo Nordisk Investigational Site
      • Sacramento, California, United States, 95825
        • Novo Nordisk Investigational Site
      • Torrance, California, United States, 90502
        • Novo Nordisk Investigational Site
      • Vacaville, California, United States, 95687
        • Novo Nordisk Investigational Site
      • Visalia, California, United States, 93277
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
      • Whittier, California, United States, 90602
        • Novo Nordisk Investigational Site
      • Whittier, California, United States, 90603-2313
        • Novo Nordisk Investigational Site
      • Yuba City, California, United States, 95991
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Novo Nordisk Investigational Site
      • Denver, Colorado, United States, 80220
        • Novo Nordisk Investigational Site
      • Lakewood, Colorado, United States, 80214
        • Novo Nordisk Investigational Site
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Novo Nordisk Investigational Site
      • Stamford, Connecticut, United States, 06902
        • Novo Nordisk Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20002
        • Novo Nordisk Investigational Site
    • Florida
      • Atlantis, Florida, United States, 33462
        • Novo Nordisk Investigational Site
      • Brandon, Florida, United States, 33511
        • Novo Nordisk Investigational Site
      • Coral Springs, Florida, United States, 33071
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32224
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33173
        • Novo Nordisk Investigational Site
      • Naples, Florida, United States, 34119
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32804
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32806
        • Novo Nordisk Investigational Site
      • Panama City, Florida, United States, 32401
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33614
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33603
        • Novo Nordisk Investigational Site
      • Weston, Florida, United States, 33331
        • Novo Nordisk Investigational Site
      • Zephyrhills, Florida, United States, 33542
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30331
        • Novo Nordisk Investigational Site
      • Augusta, Georgia, United States, 30901
        • Novo Nordisk Investigational Site
      • Augusta, Georgia, United States, 30912-3260
        • Novo Nordisk Investigational Site
      • Macon, Georgia, United States, 31217
        • Novo Nordisk Investigational Site
      • Marietta, Georgia, United States, 30066
        • Novo Nordisk Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83706
        • Novo Nordisk Investigational Site
      • Meridian, Idaho, United States, 83642
        • Novo Nordisk Investigational Site
    • Illinois
      • Crestwood, Illinois, United States, 60445
        • Novo Nordisk Investigational Site
      • Evergreen Park, Illinois, United States, 60805
        • Novo Nordisk Investigational Site
      • Gurnee, Illinois, United States, 60031
        • Novo Nordisk Investigational Site
      • Maywood, Illinois, United States, 60153
        • Novo Nordisk Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Novo Nordisk Investigational Site
      • Indianapolis, Indiana, United States, 46202
        • Novo Nordisk Investigational Site
      • Michigan City, Indiana, United States, 46360
        • Novo Nordisk Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Novo Nordisk Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Novo Nordisk Investigational Site
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
      • Wichita, Kansas, United States, 67214
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40513
        • Novo Nordisk Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • Novo Nordisk Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Novo Nordisk Investigational Site
      • Lafayatte, Louisiana, United States, 70506
        • Novo Nordisk Investigational Site
      • New Iberia, Louisiana, United States, 70563
        • Novo Nordisk Investigational Site
      • New Orleans, Louisiana, United States, 70112
        • Novo Nordisk Investigational Site
      • New Orleans, Louisiana, United States, 70121
        • Novo Nordisk Investigational Site
      • New Orleans, Louisiana, United States, 70115
        • Novo Nordisk Investigational Site
      • Shreveport, Louisiana, United States, 71101
        • Novo Nordisk Investigational Site
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Novo Nordisk Investigational Site
      • Easton, Maryland, United States, 21601
        • Novo Nordisk Investigational Site
      • Hagerstown, Maryland, United States, 21740
        • Novo Nordisk Investigational Site
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
      • Silver Spring, Maryland, United States, 20906
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Novo Nordisk Investigational Site
      • Brockton, Massachusetts, United States, 02301
        • Novo Nordisk Investigational Site
      • Springfield, Massachusetts, United States, 01107
        • Novo Nordisk Investigational Site
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Novo Nordisk Investigational Site
      • Detroit, Michigan, United States, 48202
        • Novo Nordisk Investigational Site
      • Detroit, Michigan, United States, 48236
        • Novo Nordisk Investigational Site
      • Kalamazoo, Michigan, United States, 49007
        • Novo Nordisk Investigational Site
      • Lansing, Michigan, United States, 48912
        • Novo Nordisk Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Novo Nordisk Investigational Site
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Novo Nordisk Investigational Site
      • Gulfport, Mississippi, United States, 39501
        • Novo Nordisk Investigational Site
      • Jackson, Mississippi, United States, 39216
        • Novo Nordisk Investigational Site
    • Missouri
      • St. Ann, Missouri, United States, 63074
        • Novo Nordisk Investigational Site
      • St. Louis, Missouri, United States, 63103
        • Novo Nordisk Investigational Site
      • St. Louis, Missouri, United States, 63108
        • Novo Nordisk Investigational Site
      • St. Peters, Missouri, United States, 63376
        • Novo Nordisk Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Novo Nordisk Investigational Site
    • Nebraska
      • Kearney, Nebraska, United States, 68848
        • Novo Nordisk Investigational Site
      • North Platte, Nebraska, United States, 69101
        • Novo Nordisk Investigational Site
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Novo Nordisk Investigational Site
      • Livingston, New Jersey, United States, 07039
        • Novo Nordisk Investigational Site
      • Voorhees, New Jersey, United States, 08043
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Novo Nordisk Investigational Site
    • New York
      • Bronx, New York, United States, 10467
        • Novo Nordisk Investigational Site
      • Bronx, New York, United States, 10461
        • Novo Nordisk Investigational Site
      • Brooklyn, New York, United States, 11212
        • Novo Nordisk Investigational Site
      • Brooklyn, New York, United States, 11226
        • Novo Nordisk Investigational Site
      • Buffalo, New York, United States, 14209
        • Novo Nordisk Investigational Site
      • Buffalo, New York, United States, 14086
        • Novo Nordisk Investigational Site
      • Cooperstown, New York, United States, 13326
        • Novo Nordisk Investigational Site
      • Fresh Meadows, New York, United States, 11365
        • Novo Nordisk Investigational Site
      • Mineola, New York, United States, 11501
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10016
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10025
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10021
        • Novo Nordisk Investigational Site
      • Port Washington, New York, United States, 11050
        • Novo Nordisk Investigational Site
      • Rochester, New York, United States, 14621
        • Novo Nordisk Investigational Site
      • Rosedale, New York, United States, 11422
        • Novo Nordisk Investigational Site
      • Yonkers, New York, United States, 10704
        • Novo Nordisk Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Novo Nordisk Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
      • Hamlet, North Carolina, United States, 28345
        • Novo Nordisk Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Novo Nordisk Investigational Site
      • Winston-Salem, North Carolina, United States, 27101
        • Novo Nordisk Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43210
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45428
        • Novo Nordisk Investigational Site
      • Toledo, Ohio, United States, 43606
        • Novo Nordisk Investigational Site
      • Xenia, Ohio, United States, 45385
        • Novo Nordisk Investigational Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Novo Nordisk Investigational Site
      • Medford, Oregon, United States, 97504
        • Novo Nordisk Investigational Site
      • Roseburg, Oregon, United States, 97471
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Novo Nordisk Investigational Site
      • Johnstown, Pennsylvania, United States, 15905
        • Novo Nordisk Investigational Site
      • Lewistown, Pennsylvania, United States, 17044
        • Novo Nordisk Investigational Site
      • Meadville, Pennsylvania, United States, 16335
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19144
        • Novo Nordisk Investigational Site
      • Pittsburg, Pennsylvania, United States, 15240
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • Novo Nordisk Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Novo Nordisk Investigational Site
      • Columbia, South Carolina, United States, 29209
        • Novo Nordisk Investigational Site
      • North Charleston, South Carolina, United States, 29405
        • Novo Nordisk Investigational Site
      • Orangeburg, South Carolina, United States, 29115
        • Novo Nordisk Investigational Site
      • Santee, South Carolina, United States, 29142
        • Novo Nordisk Investigational Site
      • Sumter, South Carolina, United States, 29150
        • Novo Nordisk Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Novo Nordisk Investigational Site
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • Novo Nordisk Investigational Site
      • Dyersburg, Tennessee, United States, 38024
        • Novo Nordisk Investigational Site
      • Knoxville, Tennessee, United States, 37923
        • Novo Nordisk Investigational Site
      • Knoxville, Tennessee, United States, 37920
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37232
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Novo Nordisk Investigational Site
      • Nashville, Tennessee, United States, 37205-1492
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76105
        • Novo Nordisk Investigational Site
      • Corpus Christi, Texas, United States, 78404
        • Novo Nordisk Investigational Site
      • Corpus Christi, Texas, United States, 78411
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75235
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 78216
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77099
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77003
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77004
        • Novo Nordisk Investigational Site
      • Killeen, Texas, United States, 76543
        • Novo Nordisk Investigational Site
      • Lubbock, Texas, United States, 79430
        • Novo Nordisk Investigational Site
      • McAllen, Texas, United States, 78503
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78207
        • Novo Nordisk Investigational Site
      • Tyler, Texas, United States, 75701
        • Novo Nordisk Investigational Site
      • Weslaco, Texas, United States, 78596
        • Novo Nordisk Investigational Site
    • Utah
      • Provo, Utah, United States, 84604
        • Novo Nordisk Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Novo Nordisk Investigational Site
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Novo Nordisk Investigational Site
      • Charlottesville, Virginia, United States, 22902
        • Novo Nordisk Investigational Site
      • Chesapeake, Virginia, United States, 23320
        • Novo Nordisk Investigational Site
      • Fairfax, Virginia, United States, 22030
        • Novo Nordisk Investigational Site
      • Hampton, Virginia, United States, 23667
        • Novo Nordisk Investigational Site
      • Mechanicsville, Virginia, United States, 23116
        • Novo Nordisk Investigational Site
      • Norfolk, Virginia, United States, 23507
        • Novo Nordisk Investigational Site
      • Portsmouth, Virginia, United States, 23704
        • Novo Nordisk Investigational Site
      • Salem, Virginia, United States, 24153
        • Novo Nordisk Investigational Site
    • Washington
      • Seattle, Washington, United States, 98133
        • Novo Nordisk Investigational Site
    • West Virginia
      • Bluefield, West Virginia, United States, 24701
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Glendale, Wisconsin, United States, 53209
        • Novo Nordisk Investigational Site
      • Marshfield, Wisconsin, United States, 54449
        • Novo Nordisk Investigational Site
      • Milwaukee, Wisconsin, United States, 53295
        • Novo Nordisk Investigational Site
      • Neenah, Wisconsin, United States, 54956
        • Novo Nordisk Investigational Site
      • Oshkosh, Wisconsin, United States, 54904
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Serum albumin as specified in protocol
  • Malnourished (based on serum albumin value below 40 g/L, assessed centrally)
  • Stable (for 3 months or more) and adequate haemodialysis treatment three months prior to enrolment as defined by Kt/V of more than 1.2

Exclusion Criteria:

  • Active malignant disease
  • Critical illness requiring treatment in an intensive care unit (ICU)
  • Uncontrolled treated/untreated hypertension
  • Patients on chronic (more than 3 months) treatment with steroids in doses of more than 10 mg/day prednisolone (or equivalent)
  • Patients treated with immunosuppressive agents
  • Known Growth Hormone Deficiency
  • Patients suffering from any clinically significant disease history in the opinion of the investigator
  • Severe illness as defined in the protocol (as judged by the investigator)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Somatropin
Somatropin once daily from week 0 to end of trial
Drug: somatropin
20 mcg/kg/day, injected s.c. (under the skin)
Placebo Comparator: Placebo
Placebo once daily to end of trial
Drug: placebo
Placebo injected s.c (under the skin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality - Time to All-cause Death
Time Frame: week 0, trial termination
Time to all-cause death. Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants dead estimated using Kaplan-Meier. Summary data illustrates mortality until 52 weeks, because very few subjects had trial time longer than 52 weeks. Due to early trial termination, median trial time was 17.4 weeks.
week 0, trial termination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event)
Time Frame: week 0, trial termination
Morbidity - time from week 0 to next cardiovascular event (composite of all-cause mortality and cardiovascular events defined as adjudicated medical event of special interest and categorised as myocardial infarctions, cardiac insufficiencies, strokes or other thrombo-embolic events). Statistical analysis is based on all available information from week 0 to trial termination. Summary data illustrates percentage (%) participants with events estimated using Kaplan-Meier. Summary data illustrates morbidity until 52 weeks, because very few subjects had trial time longer than 52 weeks.
week 0, trial termination
Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures
Time Frame: week 0, trial termination
The number of times that the patient was hospitalised in addition to hospitalisation for normal dialysis procedures measured from week 0 (randomisation) to the time the trial was terminated.
week 0, trial termination
Mortality - Two-year Mortality Rate
Time Frame: week 0, trial termination
week 0, trial termination
Health Related Quality of Life Assessments
Time Frame: week 0, trial termination
Summary from activity of daily living from the Rotterdam Symptom Checklist (RSCL) measuring activity from 1 (active) to 5 (inactive). The Edmonton Symptom Assessment System (ESAS), subjects assess their health in the last 24 hours on a scale from 1 (good health) to 3 (feeling poorly). The EQ-5D is a measure of subjects' health outcome from 0 (death) to 1 (full health). SF-36 (Short Form (36)) covering mental and physicial health is provided in a scale from 0-100 with higher scores indicating greater satisfaction.
week 0, trial termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 18, 2007

First Submitted That Met QC Criteria

July 18, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1630-1453
  • 2006-004702-56 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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