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Study Evaluating Cyclosporine...

Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants

Last Updated: 2011-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-08-31

Brief Summary

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Evaluate the incidence of acute rejection at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.

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Detailed Description

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Conditions

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Kidney Transplant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Cyclosporine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with end-stage renal disease scheduled to receive a primary 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, HIV, decreased platelets, elevated lipids, or multiple organ transplants.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers