Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients
A Six-month Open Label, Multicenter, Randomized Study to Evaluate the Incidence of New Onset Diabetes Mellitus and Glucose Metabolism in Patients Receiving Cyclosporine Microemulsion With C-2 Monitoring Versus Tacrolimus After de Novo Kidney Transplantation
1 other identifier
interventional
693
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2003
Typical duration for phase_4
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
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedNovember 18, 2016
November 1, 2016
2.4 years
September 12, 2005
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation.
Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.
Secondary Outcomes (7)
incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus
percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation
Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation
percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation
incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT)
6 months
- +2 more secondary outcomes
Study Arms (2)
Cyclosporine microemulsion
EXPERIMENTALTacrolimus
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \- First or second transplant, cadaveric or living donor
You may not qualify if:
- Multi-organ or dual kidney transplants
- Panel reactive antibodies \>50%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Related Publications (1)
Ekmekcioglu O, Turkan S, Yildiz S, Gunes ZE. Comparison of tacrolimus with a cyclosporine microemulsion for immunosuppressive therapy in kidney transplantation. Turk J Urol. 2013 Mar;39(1):16-21. doi: 10.5152/tud.2013.004.
PMID: 26328072RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
October 1, 2003
Primary Completion
March 1, 2006
Study Completion
March 1, 2006
Last Updated
November 18, 2016
Record last verified: 2016-11