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

April 21, 2011 updated by: Samsung Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Transplantation Center, Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cyclosporine
Drug: cyclosporine
Experimental: Tacrolimus
Drug: tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient survival
Time Frame: 5 years
5 years
Graft survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
cumulative incidence of acute rejection
Time Frame: 5 years
5 years
estimated glomerular filtration rate
Time Frame: 5 year
5 year
new-onset diabetes mellitus
Time Frame: 5 year
5 year
Hypertension
Time Frame: 5 year
5 year
hyperlipidemia
Time Frame: 5 year
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Jae-Won Joh, MD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

October 21, 2008

First Submitted That Met QC Criteria

October 21, 2008

First Posted (Estimate)

October 22, 2008

Study Record Updates

Last Update Posted (Estimate)

April 22, 2011

Last Update Submitted That Met QC Criteria

April 21, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000-07-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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