Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients
1 other identifier
interventional
830
0 countries
N/A
Brief Summary
The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2002
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 5, 2002
CompletedFirst Posted
Study publicly available on registry
June 7, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
May 14, 2010
CompletedMay 14, 2010
April 1, 2010
6.3 years
June 5, 2002
May 29, 2009
April 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nankivell Glomerular Filtration Rate (GFR)
Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.
52 weeks
Secondary Outcomes (1)
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
52 and 104 weeks
Study Arms (2)
A
ACTIVE COMPARATORConversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
B
ACTIVE COMPARATORContinued calcineurin inhibitor therapy
Interventions
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 13 years.
- Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
- Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization
You may not qualify if:
- Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
- Patients in whom kidney-pancreas or other multiple organ transplants have been performed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Reichen J, Stickel F, Bhattacharya I, Matschke K, Maller E, Korth-Bradley J. Repeat-dose sirolimus pharmacokinetics and pharmacodynamics in patients with hepatic allografts. Eur J Clin Pharmacol. 2012 May;68(5):589-97. doi: 10.1007/s00228-011-1172-7. Epub 2011 Dec 6.
PMID: 22143911DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 5, 2002
First Posted
June 7, 2002
Study Start
January 1, 2002
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
May 14, 2010
Results First Posted
May 14, 2010
Record last verified: 2010-04