Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus

Kidney Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195468
• Other study ID #: 0468H1-101116
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: March 7, 2011
• Start date: March 2004
• Est. completion date: November 2006

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchMexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• CYCLOSPORINE

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Brazil,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculated creatinine clearance at 12 months post transplantation for patients on therapy.
Secondary	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.