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Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients

NCT ID: NCT00171496

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

693 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Kidney Transplant

Keywords

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Kidney transplant, adults, NODM, immunosuppressants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cyclosporine microemulsion

Group Type EXPERIMENTAL

Cyclosporine microemulsion

Intervention Type DRUG

Tacrolimus

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

Interventions

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Cyclosporine microemulsion

Intervention Type DRUG

Tacrolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- First or second transplant, cadaveric or living donor

Exclusion Criteria

* Multi-organ or dual kidney transplants
* Panel reactive antibodies \>50%
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

References

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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.

Reference Type RESULT
PMID: 26328072 (View on PubMed)

Other Identifiers

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COLO400A2419

Identifier Type: -

Identifier Source: org_study_id