Randomized Trial of Cyclosporine and Tacrolimus Therapy With Steroid Withdrawal in Living-Donor Renal Transplantation
1 other identifier
interventional
131
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2000
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 21, 2008
CompletedFirst Posted
Study publicly available on registry
October 22, 2008
CompletedApril 22, 2011
April 1, 2011
7.8 years
October 21, 2008
April 21, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Graft survival
5 years
Patient survival
5 years
Secondary Outcomes (5)
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
Study Arms (2)
cyclosporine
ACTIVE COMPARATORTacrolimus
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- older than 15 years
- first living donor kidney transplantation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Transplantation Center, Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (1)
Lee YJ, Kim B, Lee JE, Kim YG, Kim DJ, Kim SJ, Joh JW, Oh HY, Huh W. Randomized trial of cyclosporine and tacrolimus therapy with steroid withdrawal in living-donor renal transplantation: 5-year follow-up. Transpl Int. 2010 Feb;23(2):147-54. doi: 10.1111/j.1432-2277.2009.00955.x. Epub 2009 Sep 9.
PMID: 19744223DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae-Won Joh, MD
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 21, 2008
First Posted
October 22, 2008
Study Start
July 1, 2000
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
April 22, 2011
Record last verified: 2011-04