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

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ClinicalTrials.gov Identifier: NCT00777933
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : April 22, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Living Donors Drug: tacrolimus Drug: cyclosporine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 2000
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Graft survival [ Time Frame: 5 years ]
  2. Patient survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. cumulative incidence of acute rejection [ Time Frame: 5 years ]
  2. estimated glomerular filtration rate [ Time Frame: 5 year ]
  3. new-onset diabetes mellitus [ Time Frame: 5 year ]
  4. Hypertension [ Time Frame: 5 year ]
  5. hyperlipidemia [ Time Frame: 5 year ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777933


Locations
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Korea, Republic of
Transplantation Center, Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jae-Won Joh, MD Samsung Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae-Won Joh, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00777933    
Other Study ID Numbers: 2000-07-02
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: April 22, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Cyclosporine
Tacrolimus
Cyclosporins
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents