Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation

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

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2008-05-31

Brief Summary

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The use of steroids after kidney transplantation has been challenged because of variable adverse effects which may increase the patient morbidity and mortality. The aim of this study was to compare the safety and efficacy of immunosuppressive regimens consisting of cyclosporine (CsA) and mycophenolate mofetil (MMF) or tacrolimus (TAC) and MMF after steroid withdrawal 6 months after kidney transplantation in low-risk patients.

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Detailed Description

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131 patients were randomized to CsA (n = 63) or TAC (n = 68). Of 118 patients who did not have a biopsy-proven rejection episode and who had a serum creatinine level \< 2.0 mg/dL 6 months after transplantation, 55 were of the CsA group and 63 were of the TAC group. We assessed patient and graft survival, acute rejection episodes, and adverse events 5 years after transplantation.

Conditions

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Kidney Transplantation Living Donors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cyclosporine

Group Type ACTIVE_COMPARATOR

cyclosporine

Intervention Type DRUG

Tacrolimus

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

Interventions

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tacrolimus

Intervention Type DRUG

cyclosporine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* older than 15 years
* first living donor kidney transplantation

Exclusion Criteria

* congestive heart failure (ejection fraction \< 35%)
* chronic liver disease
* underlying diabetes mellitus
* evidence of systemic infection at screening time
* history of malignant disease
* multiple organ transplantation
* positive serologic evidence of human immunodeficiency virus

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No