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

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