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

Samsung Medical Center

Status: Completed

Conditions: Kidney Transplantation; Living Donors

Treatments: Drug: tacrolimus; Drug: cyclosporine

Study type: Interventional

Funder types: Other

Identifiers

NCT00777933

2000-07-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 131 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 2 patient groups

cyclosporine

Active Comparator group

Treatment:

Drug: cyclosporine

Tacrolimus

Experimental group

Treatment:

Drug: tacrolimus