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

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Novartis

Status and phase

Completed
Phase 4

Conditions

Kidney Transplant

Treatments

Drug: Tacrolimus
Drug: Cyclosporine microemulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171496
COLO400A2419

Details and patient eligibility

About

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

Enrollment

693 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

693 participants in 2 patient groups

Cyclosporine microemulsion
Experimental group
Treatment:
Drug: Cyclosporine microemulsion
Tacrolimus
Active Comparator group
Treatment:
Drug: Tacrolimus

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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