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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00777933
First received: October 21, 2008
Last updated: April 21, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention
Kidney Transplantation
Living Donors
 Drug: tacrolimus
Drug: cyclosporine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Graft survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Patient survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cumulative incidence of acute rejection [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • estimated glomerular filtration rate [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • new-onset diabetes mellitus [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
  • Hypertension [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
  • hyperlipidemia [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Enrollment: 131
Study Start Date: July 2000
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cyclosporine Drug: cyclosporine
Experimental: Tacrolimus Drug: tacrolimus

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777933

Locations
Korea, Republic of
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
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jae-Won Joh, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00777933     History of Changes
Other Study ID Numbers: 2000-07-02
Study First Received: October 21, 2008
Last Updated: April 21, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 21, 2013