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

Not Applicable

Completed

• Conditions: Kidney Transplantation; Living Donors
• Interventions: Drug: cyclosporine; Drug: tacrolimus

• Registration Number: NCT00777933
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2000-07
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-21
• Last Update Posted: 2011-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cyclosporine	cyclosporine	-
Tacrolimus	tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Graft survival	5 years
Patient survival	5 years

Secondary Outcome Measures

Name	Time	Method
cumulative incidence of acute rejection	5 years
estimated glomerular filtration rate	5 year
new-onset diabetes mellitus	5 year
Hypertension	5 year
hyperlipidemia	5 year

Trial Locations

Locations (1)

Transplantation Center, Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of