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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00777933
• Collaborator: (none)
• Enrollment: 131
• Location: 1
• Arms: 2
• Duration (Months): 94
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation; Living Donors	Drug: tacrolimus; Drug: cyclosporine	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 131 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation
• Study Start Date: Jul 1, 2000
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Graft survival [5 years]

2. Patient survival [5 years]

Secondary Outcome Measures

1. cumulative incidence of acute rejection [5 years]

2. estimated glomerular filtration rate [5 year]

3. new-onset diabetes mellitus [5 year]

4. Hypertension [5 year]

5. hyperlipidemia [5 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Transplantation Center, Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00777933
• Other Study ID Numbers: 2000-07-02
• First Posted: Oct 22, 2008
• Last Update Posted: Apr 22, 2011
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins

Study Results

No Results Posted as of Apr 22, 2011