Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (TEMPO3:4)
2017년 5월 30일 업데이트: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
연구 개요
상세 설명
This study evaluated whether or not tolvaptan is potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total kidney volume increase, while impacting the onset, severity, and progression of other important consequences of ADPKD.
During the 3-week titration phase, tolvaptan or placebo was titrated in weekly intervals from lowest to highest tolerated levels given in split-dose regimens of 45/15 mg, 60/30 mg and 90/30 mg orally upon awakening and approximately 9 hours later. As soon as a subject could not tolerate a given dose, the titration phase was over and the maintenance phase began at the dose level tolerated. The maintenance phase lasted to Month 36. Subjects were able to titrate down at any point during the study. Subjects were able to titrate up during the maintenance phase with Medical Monitor approval.
연구 유형
중재적
등록 (실제)
1445
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Amsterdam, 네덜란드, 1081 HV
- VU Medisch Centrum
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Groningen, 네덜란드, 9713 GZ
- UMCG Groningen
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Herlev, 덴마크, 2730
- Herlev Amtssygehus
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Odense, 덴마크, 5000
- Odense Universitetshospital
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Dresden, 독일, 1307
- Universitatsklinikum Carl Gustav Carus
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Düsseldorf, 독일, 40210
- Nephrologische Gemeinschaftspraxis/Dialysezentrum
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Essen, 독일, 45147
- Klinik für Nieren- und Hochdruckkrankheiten
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Freiburg, 독일, 78106
- Universitatsklinikum Freiburg
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Heidelberg, 독일, 69120
- Universitätskliniken Heidelberg
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Nuernberg, 독일, 90471
- UH Erlangen/Nürnberg
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Kemerovo, 러시아 연방, 650061
- Kemerovo Medical Academy, Regional Clinical Hospital
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Moscow, 러시아 연방, 123060
- City Clinical Hospital #52
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St. Petersburg, 러시아 연방, 191104
- City Mariinskiy Hospital
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St.-Petersburg, 러시아 연방, 194291
- Leningrad Regional Clinical Hospital
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Tomsk, 러시아 연방, 634063
- Tomsk Regional Clinical Hospital
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Bucharest, 루마니아, 22328
- Institutul Clinic Fundeni
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Bucharest, 루마니아, 10731
- Spitalul Clinic de Nefrologie Dr. Carol Davila
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Iasi, 루마니아, 700503
- Spitalul Clinic "C.I.Parhon"
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Alabama
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Mobile, Alabama, 미국, 36617
- University of South Alabama
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Mobile, Alabama, 미국, 36608
- Coastal Clinical Research
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California
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Riverside, California, 미국, 92503
- Apex Research of Riverside
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Stanford, California, 미국, 94305-5114
- Stanford University Medical Center
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Colorado
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Denver, Colorado, 미국, 80262
- University of Colorado Health Sciences Center
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Connecticut
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New Haven, Connecticut, 미국, 06510
- Yale University School of Medicine
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Florida
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Jacksonville, Florida, 미국, 32216
- Jacksonville Center for Clinical Research
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Port Charlotte, Florida, 미국, 33952
- Coastal Nephrology Associates Research Center, LLC
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Georgia
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Atlanta, Georgia, 미국, 30308
- Emory University School of Medicine
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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Louisiana
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Baton Rouge, Louisiana, 미국, 70809
- Renal Associates of Baton Rough, L.L.C.
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Maryland
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Baltimore, Maryland, 미국, 21205
- John Hopkins School of Medicine
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, 미국, 02111
- Tufts- New England Medical Center
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Medical Center
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New York
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Buffalo, New York, 미국, 14215
- Erie County Medical Center
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Hawthorne, New York, 미국, 10532
- Nephrology Associates of Westchester
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New York, New York, 미국, 10032
- Columbia University Medical Center
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New York, New York, 미국, 10021
- The Rogosin Institute
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- University of North Carolina, UNC, Kidney Center
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Greenville, North Carolina, 미국, 27834
- East Carolina University
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Ohio
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Cincinnati, Ohio, 미국, 45220
- Kidney and Hypertension Center
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Cleveland, Ohio, 미국, 44106
- University Hospitals of Cleveland/Case
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Oregon
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Portland, Oregon, 미국, 97210
- Northwest Renal Clinic, Inc.
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania Medical Center
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South Carolina
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Charleston, South Carolina, 미국, 29405
- Charleston Nephrology Associates
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Tennessee
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Nashville, Tennessee, 미국, 37205
- Nephrology Associates, P.C.
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Nashville, Tennessee, 미국, 37232-1371
- Vanderbilt University Medical Center
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Virginia
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Charlottesville, Virginia, 미국, 22908
- University of Virginia, Nephrology Clinical Research Center
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Brussel, 벨기에, 1090
- UZ Brussel
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Brussels, 벨기에, 1200
- UCL-St Luc
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Gent, 벨기에, 9000
- UZ Gent
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Buenos Aires, 아르헨티나, 1425
- Instituto de Nefrología, Nefrology SA
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Buenos Aires, 아르헨티나, 1602
- Hospital Municipal de Vicente Lopez, Dr Bernardo Houssay
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Buenos Aires, 아르헨티나, B1664INZ
- Hosptial Universitario Austral
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Cordoba, 아르헨티나, X5000IUP
- Sanatorio Allende
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Cordoba, 아르헨티나, X5016KEA
- Hospital Privado-Centro Medico de Cordoba
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Belfast, 영국, BT9 7AB
- Belfast City Hospital
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Birmingham, 영국, B15 2TH
- Oueen Elizabeth Hospital
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Brighton, 영국, BN2 5BE
- Sussex Renal Unit Royal Sussex County Hospital
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Coventry, 영국, CV2 2DX
- Uhcw Mhs Trust
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Edinburgh, 영국, EH16 4SA
- Royal Infirmary
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Inverness, 영국, IV2 3UJ
- Raigmore Hospital
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London, 영국, NW3 2PF
- Royal Free and University College Medical School
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London, 영국, SE5-9RS
- King's College Hospital
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London, 영국, SW170RE
- St. George's Hospital
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Sheffield, 영국, S5 7AU
- Royal Hallamshire Hospital
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Swansea, 영국, SA6 6NL
- Morriston Hospital
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Bergamo, 이탈리아, 24128
- Ospedali Riuniti di Bergamo
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Milano, 이탈리아, 20132
- Università Vita e Salute, Ospedale San Raffaele
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Modena, 이탈리아, 41100
- Policlinico di Modena
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Napoli, 이탈리아, 80131
- Policlinico
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Pavia, 이탈리아, 27100
- IRCCS Fondazione Salvatore Maugeri
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Chiba, 일본, 2608677
- Chiba University Hospital
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Chiba, 일본, 2608712
- National Hospital Organization Chiba-East Hospital
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Fukuoka, 일본, 8128582
- Kyusyu University Hospital
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Fukushima, 일본, 9601295
- Fukushima Medical University Hospital
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Hiroshima, 일본, 7348551
- Hiroshima University Hospital
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Kumamoto, 일본, 8608556
- Kumamoto Univeristy Hospital
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Kyoto, 일본, 6068507
- Kyoto University Hospital
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Kyoto, 일본, 612-8555
- National Hospital Organization Kyoto Medical Center
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Niigata, 일본, 9518520
- Niigata University Medical & Dental Hospital
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Osaka, 일본, 5500015
- Ohno Memorial Hospital
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Saitama, 일본, 3308503
- Saitama Medical Center Jichi Medical University
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Aichi
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Toyoake, Aichi, 일본, 4701192
- Fujita Health University Hospital
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Hokkaido
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Sapporo, Hokkaido, 일본, 608648
- Hokkaido University Hospital
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Kanagawa
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Isehara, Kanagawa, 일본, 2591193
- Tokai University Hospital
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Kawasaki, Kanagawa, 일본, 2138587
- Toranomon Hospital Kajigaya
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Sagamihara, Kanagawa, 일본, 2288555
- Kitasato University Hospital
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Miyagi
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Sendai, Miyagi, 일본, 9808574
- Tohoku University Hospital
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Osaka
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Osaka-City, Osaka, 일본, 5458586
- Osaka City University Hospital
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Suita, Osaka, 일본, 5650871
- Osaka University Hospital
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Saitama
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Kasukabe, Saitama, 일본, 3440035
- Shuwa General Hospital
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Kawagoe, Saitama, 일본, 3508500
- Saitama Medical Center
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Shizuoka
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Hamamatsu, Shizuoka, 일본, 4313192
- Hamamatsu University School of Medicine, University Hospital
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Tochigi
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Shimotsuke, Tochigi, 일본, 3290498
- Jichi Medical School Hospital
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Tokyo
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Bunkyo-ku, Tokyo, 일본, 1138603
- Nippon Medical School Hospital
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Bunkyo-ku, Tokyo, 일본, 1138519
- Tokyo Medical & Dental University Hospital, Faculty of Medicine
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Itabashi-ku, Tokyo, 일본, 1738606
- Teikyo University Hospital
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Minato-Ku, Tokyo, 일본, 1058471
- The Jikei University Hospital
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Minato-ku, Tokyo, 일본, 1058470
- Toranomon Hospital
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Mitaka, Tokyo, 일본, 1818611
- Kyorin University Hospital
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Shinjuku-ku, Tokyo, 일본, 1628666
- Tokyo Women's Medical University Hospital
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H1v8
- Queen Elizabeth II Health Science Center, Division of Nephrology
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Quebec
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Montreal, Quebec, 캐나다, H3A1A1
- Royal Victoria Hospital
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Montreal, Quebec, 캐나다, H4J1C5
- Hospital du Sacre- Coeur de Montreal
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Ciechanow, 폴란드, 06-400
- Oddział Nefrologiczny Stacja Dializ
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Gdansk, 폴란드, 80-952
- Akademickie Centrum Kliniczne AMG
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Gdansk, 폴란드, 80-952
- Samodzielny Publiczny Szpital Kliniczny nr 1, Akademickie Centrum Kliniczne AMG
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Krakow, 폴란드, 31-501
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie
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Lodz, 폴란드, 90-153
- SOP ZOZ Uniwersytecki Szpital Kliniczny
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Lublin, 폴란드, 20-954
- Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
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Warsaw, 폴란드, 04-749
- Międzyleski Szpital Specjalistyczny w Warszawie
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Warsaw, 폴란드, 02-507
- Klinika Chorób Wewnętrznych i Nefrologii
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Warszawa, 폴란드, 03-401
- Szpital Praski p.w. Przemienienia Panskiego, Samodzielny Publiczny Zaklad Opieki Zdrowotnej
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Warszawa, 폴란드, 03-401
- Szpital Praski, Samodzielny Publiczny ZOZ
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Wroclaw, 폴란드, 50-417
- Akademicki Szpital Kliniczny im J Mikulicza Radeckiego
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Bordeaux, 프랑스, 33076
- CHU-Hopital Pellegrin
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Caen Cedex, 프랑스, 14033
- CHU - Hôpital Clémenceau
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Lyon Cedex 3, 프랑스, 69437
- Hôpital Edouard Herriot
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Marseille, 프랑스, 13005
- Hopital de la Conception
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Montpellier, 프랑스, 34295
- CHU - Hôpital Lapeyronie
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Paris, 프랑스, 75018
- Hôpital Bichat-Claude Bernard
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Reims cedex, 프랑스, 51092
- Centre Hospitalier Universitaire
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Saint-Etienne Cedex 2, 프랑스, 42055
- Chu - Hopital Nord
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Toulouse Cedex 09, 프랑스, 31059
- Hopital Rangueil
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Adelaide, 호주, 5000
- Royal Adelaide Hospital
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Adelaide, 호주, 5011
- Queen Elizebeth Hospital
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Brisbane, 호주, 4102
- Princess Alexandra Hospital
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Melbourne, 호주, 3050
- Royal Melbourne Hospital
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Melbourne, 호주, 3121
- Melbourne Renal Research Group
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Perth, 호주, 6054
- Royal Perth Hospital
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Sydney, 호주, 2065
- Royal North Shore Hospital
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Sydney, 호주, 2145
- Westmead Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Legal adult age and able to give Informed Consent.
- Adult subjects with a diagnosis of ADPKD. A diagnosis of ADPKD (age 18 or 20-50) required several cysts in each kidney (3 if by sonography, 5 if by CT or MRI) in those with a family history of ADPKD and 10 cysts (by any radiologic method) in each kidney and exclusion of other cystic kidney diseases if there was no family history.
- Willingness to comply with reproductive precautions, if female.
- Estimated creatinine clearance ≥ 60 mL/min. Estimated from serum creatinine during screening using Cockcroft-Gault with correction for gender and race, where possible.
- Rapidly progressive kidney growth (total volume ≥ 750 cc) by magnetic resonance imaging (MRI) at randomization.
Exclusion Criteria:
- Prior exposure to tolvaptan or other experimental PKD therapies.
- Currently taking medication for purpose of affecting PKD cysts.
- Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
- In the opinion of the study investigator or sponsor may present a safety risk or confound study objectives.
- Patients who are unlikely to adequately comply with study procedures.
- Patients having contraindications to MRI.
- Patients taking medications or having any illnesses likely to affect ADPKD outcomes.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Tolvaptan
Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months.
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Tolvaptan was supplied as tablets.
다른 이름들:
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위약 비교기: Placebo
Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
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Placebo was supplied as tablets.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage Change Per Year in Total Kidney Volume From Baseline to Month 36
기간: Baseline to Month 36
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Kidney volume was assessed in T1-weighted magnetic resonance images collected at each study site and sent to a central reviewing facility.
At the central reviewing facility, blinded radiologists used proprietary software to measure the volume of both kidneys.
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Baseline to Month 36
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of ADPKD Clinical Progression Events Per 100 Follow-up Years From Baseline to Month 36
기간: Baseline to Month 36
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These ADPKD events in the key secondary Outcome Measure were selected on the basis of their potential relationship to progressing cystogenesis.
Reducing the rate of cyst development and expansion would likely slow the progression of ADPKD.
The 4 events were: (1) Onset or progression of hypertension (someone is hypertensive if they have > 139 mmHg systolic blood pressure [BP], > 89 mmHg diastolic BP, or if they are taking antihypertensive medication at any BP level); (2) severe renal pain requiring medical intervention; (3) worsening albuminuria (by category, see below); and (4) worsening renal function, defined as a 25% decrease in 1/serum creatinine from Baseline.
Albuminuria was assessed using spot urine albumin/creatinine ratio measurements (all measurements in mg/mmol).
Categories included normal (< 2.8 female or < 2.0 male), microalbuminuria (2.8-28 female or 2.0-20 male), and overt proteinuria (> 28 female or > 20 male.
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Baseline to Month 36
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Change in Renal Function Per Year From Week 3 to Month 36
기간: Week 3 to Month 36
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Renal function was assessed using serum creatinine measurements and was estimated using 1/serum creatinine.
The formula for 1/serum creatinine is: 1/Pcr, where Pcr = serum creatinine concentration (mg/dL).
The change in renal function per year was based on the slope of change, obtained by regressing renal function data against time by subject.
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Week 3 to Month 36
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Change in Mean Arterial Blood Pressure Per Year in Non-hypertensive Participants From Baseline to Month 36
기간: Baseline to Month 36
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For participants who were non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) at baseline, mean arterial blood pressure was measured at scheduled clinic visits up to the point of exposure to antihypertensive therapy for any reason.
The change in mean arterial blood pressure per year was based on the slope of blood pressure, obtained by regressing blood pressure against time by subject.
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Baseline to Month 36
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Area Under the Concentration-time Curve of Change in Renal Pain From Baseline to Month 36
기간: At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2
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Change from baseline in renal pain was assessed by a 0 to 10 pain scale as average area under the concentration-time curve (AUC) between baseline and the last trial visit or the last visit prior to initiating medical (eg, narcotic or anti-nociceptives [eg, tricyclic antidepressants]) or surgical therapy for pain.
In the pain scale, score 0 represented no pain at all and score 10 represented the worst pain.
A negative change score indicates less pain.
AUC of renal pain was derived from renal pain scores within treatment period and was calculated using the trapezoidal rule, by dividing the number of days between the first and last assessment.
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At screening, Baseline, Day 1, every 4 months up to month 36/early tremination (ET), follow-up visit 1 and 2
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Number of Hypertensive Events Per 100 Follow-up Years in Non-hypertensive Participants From Baseline to Month 36
기간: Baseline to Month 36
|
A hypertensive event was defined as a change from non-hypertensive (systolic BP ≤ 139 mmHg and diastolic BP ≤ 89 mmHg without taking antihypertensive medications) status to 1 of 3 conditions: (1) High pre-hypertensive (systolic BP [sBP] > 129 mmHg and/or diastolic BP [dBP] > 84 mmHg), (2) hypertensive (sBP > 139 mmHg and/or dBP > 89 mmHg), or (3) requiring antihypertensive therapy.
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Baseline to Month 36
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Percentage of Participants With a Clinically Sustained Decrease of Blood Pressure Leading to a Sustained Reduction in Antihypertensive Therapy From Baseline to Month 36
기간: Baseline to Month 36
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Baseline to Month 36
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Vicente Torres, MD, PhD, Mayo Medical Center
- 연구 책임자: Frank Czerwiec, MD, PhD, Otsuka Pharmaceutical Development and Commercialization, Inc.
- 연구 책임자: Osamu Sato, Otsuka Pharmaceutical Corporation, Ltd. Japan
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang J, Czerwiec FS; TEMPO 3:4 Trial Investigators. Tolvaptan in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2012 Dec 20;367(25):2407-18. doi: 10.1056/NEJMoa1205511. Epub 2012 Nov 3.
- Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5.
- Gattone VH 2nd, Wang X, Harris PC, Torres VE. Inhibition of renal cystic disease development and progression by a vasopressin V2 receptor antagonist. Nat Med. 2003 Oct;9(10):1323-6. doi: 10.1038/nm935. Epub 2003 Sep 21.
- Torres VE, Wang X, Qian Q, Somlo S, Harris PC, Gattone VH 2nd. Effective treatment of an orthologous model of autosomal dominant polycystic kidney disease. Nat Med. 2004 Apr;10(4):363-4. doi: 10.1038/nm1004. Epub 2004 Feb 29.
- Watkins PB, Lewis JH, Kaplowitz N, Alpers DH, Blais JD, Smotzer DM, Krasa H, Ouyang J, Torres VE, Czerwiec FS, Zimmer CA. Clinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database. Drug Saf. 2015 Nov;38(11):1103-13. doi: 10.1007/s40264-015-0327-3.
- Torres VE, Meijer E, Bae KT, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang JJ, Czerwiec FS. Rationale and design of the TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) 3-4 Study. Am J Kidney Dis. 2011 May;57(5):692-9. doi: 10.1053/j.ajkd.2010.11.029. Epub 2011 Feb 17.
- Kher A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257-8. doi: 10.1056/NEJMc1300762. No abstract available.
- Spital A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257. doi: 10.1056/NEJMc1300762. No abstract available.
- Torres VE, Gansevoort RT, Czerwiec FS. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1259. doi: 10.1056/NEJMc1300762. No abstract available.
- Jouret F, Krzesinski JM. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258-9. doi: 10.1056/NEJMc1300762. No abstract available.
- Sexton DJ. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258. doi: 10.1056/NEJMc1300762. No abstract available.
- Nowak KL, Steele C, Gitomer B, Wang W, Ouyang J, Chonchol MB. Overweight and Obesity and Progression of ADPKD. Clin J Am Soc Nephrol. 2021 Jun;16(6):908-915. doi: 10.2215/CJN.16871020. Epub 2021 Jun 11.
- Heida JE, Gansevoort RT, Torres VE, Devuyst O, Perrone RD, Lee J, Li H, Ouyang J, Chapman AB. The Effect of Tolvaptan on BP in Polycystic Kidney Disease: A Post Hoc Analysis of the TEMPO 3:4 Trial. J Am Soc Nephrol. 2021 Jul;32(7):1801-1812. doi: 10.1681/ASN.2020101512. Epub 2021 Apr 22.
- McEwan P, Bennett Wilton H, Ong ACM, Orskov B, Sandford R, Scolari F, Cabrera MV, Walz G, O'Reilly K, Robinson P. A model to predict disease progression in patients with autosomal dominant polycystic kidney disease (ADPKD): the ADPKD Outcomes Model. BMC Nephrol. 2018 Feb 13;19(1):37. doi: 10.1186/s12882-017-0804-2.
- Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Perrone RD, Dandurand A, Ouyang J, Czerwiec FS, Blais JD; TEMPO 4:4 Trial Investigators. Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic kidney disease: the TEMPO 4:4 Trial. Nephrol Dial Transplant. 2018 Mar 1;33(3):477-489. doi: 10.1093/ndt/gfx043.
- Muto S, Kawano H, Higashihara E, Narita I, Ubara Y, Matsuzaki T, Ouyang J, Torres VE, Horie S. The effect of tolvaptan on autosomal dominant polycystic kidney disease patients: a subgroup analysis of the Japanese patient subset from TEMPO 3:4 trial. Clin Exp Nephrol. 2015 Oct;19(5):867-77. doi: 10.1007/s10157-015-1086-2. Epub 2015 Feb 7.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2007년 1월 1일
기본 완료 (실제)
2012년 1월 1일
연구 완료 (실제)
2012년 1월 1일
연구 등록 날짜
최초 제출
2007년 1월 26일
QC 기준을 충족하는 최초 제출
2007년 1월 29일
처음 게시됨 (추정)
2007년 1월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 7월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 5월 30일
마지막으로 확인됨
2017년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 156-04-251
- 2006-002768-24 (EudraCT 번호)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .