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

Phase 4CompletedNCT00195468

Wyeth is now a wholly owned subsidiary of Pfizer280 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

280

Conditions

Kidney Failure Graft vs Host Disease

Interventions

CYCLOSPORINEDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (13)

Unnamed facility

Curitiba, Paraná, Brazil

Unnamed facility

Rio de Janeiro, Rio de Janeiro, Brazil

Unnamed facility

Rio de Janeiro, Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

Calculated creatinine clearance at 12 months post transplantation for patients on therapy.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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