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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00171496
Other study ID # COLO400A2419
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated November 16, 2016
Start date October 2003
Est. completion date March 2006

Study information

Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 693
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- First or second transplant, cadaveric or living donor

Exclusion Criteria:

- Multi-organ or dual kidney transplants

- Panel reactive antibodies >50%

Other protocol-defined inclusion/exclusion criteria applied

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Cyclosporine microemulsion

Tacrolimus


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novartis

References & Publications (1)

Ekmekçioglu O, Turkan S, Yildiz S, Günes 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.
Secondary incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus
Secondary percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation
Secondary Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation
Secondary percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation
Secondary incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT) 6 months
Secondary Blood pressure at Months 3& 6 post-transplantation
Secondary incidence of BPAR or graft loss or death within the first 3 months post-transplantation, as well as the incidence of each individual event within 3 and 6 months post-transplantation.
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