Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II)...
Date First Received: September 13, 2005
Last Updated: December 20, 2007
Verified by: Wyeth, December 2007
Clinical Trial Phase: Phase 4 | Start Date: March 2004
Overall Status: Completed
Estimated Enrollment: 280
Brief Summary
Official Title: “A Randomized, Open-Label Study to Compare the Safety and Efficacy of Cyclosporine Dose Reduction With Cyclosporine Elimination in De Novo Renal Allograft Recipients Receiving Rapamune.”
Condition Keyword(s):
Intervention(s):
Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: November 2006
Intervention(s) in this Clinical Trial
- Drug: CYCLOSPORINE
Outcome Measures for this Clinical Trial
Primary Measures
- Calculated creatinine clearance at 12 months post transplantation for patients on therapy.
Secondary Measures
- Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age.
Exclusion Criteria:
- Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on September 08, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00195468
Study ID Number: 048H1-101116
ClinicalTrials.gov Identifier: NCT00195468
Health Authority: Brazil: National Committee of Ethics in Research
Clinical Trials Authorship and Review
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