Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice (TOP)

December 11, 2014 updated by: AbbVie (prior sponsor, Abbott)

Long-Term Therapy Outcomes When Treating CKD-patients With Paricalcitol in German Clinical Practice (TOP Study)

The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

Study Overview

Status

Completed

Conditions

Detailed Description

According to protocol amendment of 16 October 2010 Austria is participating in this study.

Paricalcitol injection (intravenous (IV) therapy) was approved in Germany in December 2004 and in Austria in June 2003 for the prevention and treatment of secondary hyperparathyroidism in participants needing dialysis. In April 2008 in Germany and in January 2008 in Austria, paricalcitol capsules (for oral use (p.o.)) were launched for the prevention and treatment of secondary hyperparathyroidism in individuals with Chronic Kidney Disease stage 3 - 5 (i.e., predialysis and dialysis), thus enabling early treatment of participants with chronic kidney disease before they reach the stage of requiring dialysis.

Postmarketing observational studies with a well-planned study design, defined study protocol and biometrical estimates are necessary for a more profound understanding of the effectiveness and adverse drug reactions, especially those that are unknown or rare.

Accordingly, the purpose of this study is to obtain data on the safety and effectiveness of paricalcitol injection and capsules in real-life clinical practice. In this study, paricalcitol will be prescribed on an on-label basis in an everyday setting. A period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.

Study Type

Observational

Enrollment (Actual)

761

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

  • Austria
      • Feldkirch, Austria, 6800
        • Site Reference ID/Investigator# 64522
      • Graz, Austria, 8010
        • Site Reference ID/Investigator# 53506
      • Graz, Austria, 8036
        • Site Reference ID/Investigator# 53524
      • Innsbruck, Austria, 6020
        • Site Reference ID/Investigator# 74733
      • Rottenmann, Austria, 8786
        • Site Reference ID/Investigator# 64523
      • Salzburg, Austria, 5020
        • Site Reference ID/Investigator# 53525
      • St. Poelten, Austria, 3100
        • Site Reference ID/Investigator# 53526
      • Steyr, Austria, 4400
        • Site Reference ID/Investigator# 69662
      • Vienna, Austria, 1090
        • Site Reference ID/Investigator# 53508
      • Vienna, Austria, 1130
        • Site Reference ID/Investigator# 53523
      • Vienna, Austria, 1220
        • Site Reference ID/Investigator# 53507
  • Germany
      • Aachen, Germany, 52066
        • Site Reference ID/Investigator# 28352
      • Alsfeld, Germany, 36304
        • Site Reference ID/Investigator# 28359
      • Arnstadt, Germany, 99310
        • Site Reference ID/Investigator# 28305
      • Aschersleben, Germany, 06449
        • Site Reference ID/Investigator# 28306
      • Augsburg, Germany, 86154
        • Site Reference ID/Investigator# 28003
      • Aurich, Germany, 26605
        • Site Reference ID/Investigator# 81613
      • Bad Bevensen, Germany, 29549
        • Site Reference ID/Investigator# 28017
      • Bad Nenndorf, Germany, 31542
        • Site Reference ID/Investigator# 28301
      • Balingen, Germany, 72336
        • Site Reference ID/Investigator# 28296
      • Berlin, Germany, 10785
        • Site Reference ID/Investigator# 28021
      • Berlin, Germany, 12435
        • Site Reference ID/Investigator# 28024
      • Berlin, Germany, 12627
        • Site Reference ID/Investigator# 28303
      • Berlin, Germany, 14193
        • Site Reference ID/Investigator# 54050
      • Bernburg, Germany, 06406
        • Site Reference ID/Investigator# 28022
      • Betzdorf, Germany, 57518
        • Site Reference ID/Investigator# 30862
      • Bielefeld, Germany, 33609
        • Site Reference ID/Investigator# 28007
      • Burg, Germany, 39288
        • Site Reference ID/Investigator# 28304
      • Coburg, Germany, 96450
        • Site Reference ID/Investigator# 28014
      • Cottbus, Germany, 03046
        • Site Reference ID/Investigator# 28023
      • Demmin, Germany, 17109
        • Site Reference ID/Investigator# 28134
      • Dresden, Germany, 01217
        • Site Reference ID/Investigator# 28037
      • Dresden, Germany, 01307
        • Site Reference ID/Investigator# 43903
      • Elmshorn, Germany, 25337
        • Site Reference ID/Investigator# 99777
      • Elsenfeld, Germany, 63820
        • Site Reference ID/Investigator# 28284
      • Emden, Germany, 26721
        • Site Reference ID/Investigator# 124118
      • Emsdetten, Germany, 48282
        • Site Reference ID/Investigator# 54054
      • Erfurt, Germany, 99089
        • Site Reference ID/Investigator# 48864
      • Erkelenz, Germany, 41812
        • Site Reference ID/Investigator# 72343
      • Eschweiler, Germany, 52249
        • Site Reference ID/Investigator# 28029
      • Friedrichroda, Germany, 99894
        • Site Reference ID/Investigator# 28287
      • Gera, Germany, 07548
        • Site Reference ID/Investigator# 28276
      • Halle, Germany, 06118
        • Site Reference ID/Investigator# 28351
      • Hamburg, Germany, 22767
        • Site Reference ID/Investigator# 28280
      • Hanover, Germany, 30625
        • Site Reference ID/Investigator# 48865
      • Heilbronn, Germany, 74076
        • Site Reference ID/Investigator# 28300
      • Herford, Germany, 32049
        • Site Reference ID/Investigator# 28011
      • Herne, Germany, 44623
        • Site Reference ID/Investigator# 124119
      • Herzberg, Germany, 04916
        • Site Reference ID/Investigator# 28019
      • Hildesheim, Germany, 31134
        • Site Reference ID/Investigator# 28135
      • Hoyerswerda, Germany, 02977
        • Site Reference ID/Investigator# 28286
      • Ilfeld, Germany, 99768
        • Site Reference ID/Investigator# 28353
      • Jena, Germany, 07743
        • Site Reference ID/Investigator# 28044
      • Kiel, Germany, 24106
        • Site Reference ID/Investigator# 48863
      • Lahr, Germany, 77933
        • Site Reference ID/Investigator# 28013
      • Loerrach, Germany, 79539
        • Site Reference ID/Investigator# 28025
      • Ludwigslust, Germany, 19288
        • Site Reference ID/Investigator# 28290
      • Magdeburg, Germany, 39108
        • Site Reference ID/Investigator# 10982
      • Malente, Germany, 23714
        • Site Reference ID/Investigator# 28291
      • Mannheim, Germany, 68309
        • Site Reference ID/Investigator# 28036
      • Marburg, Germany, 35043
        • Site Reference ID/Investigator# 28302
      • Minden, Germany, 32429
        • Site Reference ID/Investigator# 54051
      • Muellheim, Germany, 79379
        • Site Reference ID/Investigator# 28278
      • Munich, Germany, 80336
        • Site Reference ID/Investigator# 99778
      • Neumuenster, Germany, 24534
        • Site Reference ID/Investigator# 99776
      • Nordhorn, Germany, 48527
        • Site Reference ID/Investigator# 124120
      • Nordhorn, Germany, 48529
        • Site Reference ID/Investigator# 28275
      • Oberstdorf, Germany, 87561
        • Site Reference ID/Investigator# 43904
      • Osnabrueck, Germany, 49074
        • Site Reference ID/Investigator# 28277
      • Peine, Germany, 31224
        • Site Reference ID/Investigator# 28297
      • Pirmasens, Germany, 66953
        • Site Reference ID/Investigator# 28307
      • Potsdam, Germany, 14482
        • Site Reference ID/Investigator# 28295
      • Quedlinburg, Germany, 06484
        • Site Reference ID/Investigator# 28294
      • Rendsburg, Germany, 24768
        • Site Reference ID/Investigator# 48862
      • Ribnitz-Damgarten, Germany, 18311
        • Site Reference ID/Investigator# 28042
      • Rostock, Germany, 18107
        • Site Reference ID/Investigator# 28282
      • St. Wendel, Germany, 66606
        • Site Reference ID/Investigator# 28033
      • Stuttgart, Germany, 70199
        • Site Reference ID/Investigator# 54052
      • Stuttgart, Germany, 70376
        • Site Reference ID/Investigator# 28005
      • Viersen, Germany, 41751
        • Site Reference ID/Investigator# 28020
      • Villingen-Schwenningen, Germany, 78054
        • Site Reference ID/Investigator# 28293
      • Voelklingen, Germany, 66333
        • Site Reference ID/Investigator# 28018
      • Weissenfels, Germany, 06667
        • Site Reference ID/Investigator# 28298
      • Wetzlar, Germany, 35578
        • Site Reference ID/Investigator# 28292
      • Wiesbaden, Germany, 65191
        • Site Reference ID/Investigator# 48882
      • Wolfenbuettel, Germany, 38304
        • Site Reference ID/Investigator# 28299
      • Zwickau, Germany, 08056
        • Site Reference ID/Investigator# 28279

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

Sampling Method

Non-Probability Sample

Study Population

Participating sites were facilities specialized in the treatment of chronic kidney disease and offices of community-based specialists/nephrologists in Germany and Austria.

Description

Inclusion Criteria:

  • The inclusion criteria are based on the Summary of Product Characteristics for paricalcitol injection and capsules: Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease
  • Patients not treated with paricalcitol for at least 6 months prior to inclusion in this study

Exclusion Criteria:

  • The contraindications listed in the Summary of Product Characteristics for paricalcitol injection and capsules apply
  • An additional exclusion criterion is a parathyroid hormone- value of > 1000 pg/mL (which may be a sign of tertiary hyperparathyroidism) and existing treatment with paricalcitol

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Paricalcitol
Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
Time Frame: Up to 12 Months
Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).
Up to 12 Months
Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months
Time Frame: Up to 12 months
Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Hypercalcemia
Time Frame: Months 0, 3, 6, 9, and 12
Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.
Months 0, 3, 6, 9, and 12
Number of Participants With Hyperphosphatemia
Time Frame: Months 0, 3, 6, 9, and 12
Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.
Months 0, 3, 6, 9, and 12
Number of Participants With Elevated Calcium-Phosphorus Product
Time Frame: Months 0, 3, 6, 9, and 12
Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg^2/dL^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.
Months 0, 3, 6, 9, and 12
Mean Duration of Hospitalization by Visit
Time Frame: Months 0, 3, 6, 9, and 11
Months 0, 3, 6, 9, and 11
Mean Duration of Disability by Visit
Time Frame: Months 0, 3, 6, 9, and 11
Months 0, 3, 6, 9, and 11
Mean Intact Parathormone (iPTH) Levels by Visit
Time Frame: Months 0, 3, 6, 9, and 12
Months 0, 3, 6, 9, and 12
Mean Calcium-Phosphate Product Levels by Visit
Time Frame: Months 0, 3, 6, 9, and 12
Months 0, 3, 6, 9, and 12

Collaborators and Investigators

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

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Sabine Decker-Burgard, MD, AbbVie

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.

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

March 1, 2008

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P10-681

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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