Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus

Wyeth

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Sirolimus; Drug: Cyclosporine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00507793

0468E1-4351

Details and patient eligibility

About

To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.

Full description

To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients. Cyclosporine blood levels, graft rejection rates and renal function will be assessed.

Enrollment: 385 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• At least 18 years of age
• End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
• Patients with secondary kidney transplant must have maintained primary graft for at least 6 months

Exclusion criteria

• Antibody induction within one week of current transplantation
• Multiorgan transplants
• Patients at high-risk of rejection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)