Study Evaluating Sirolimus in the Treatment of Kidney Transplant

Wyeth

Status and phase: Completed; Phase 4

Conditions: Kidney Failure; Kidney Diseases

Treatments: Drug: Sirolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00282217

101467

Details and patient eligibility

About

The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Renal transplantation
• Biopsy-confirmed chronic rejection
• Treatment with mofetil mycophenolate among cyclosporine or tacrolimus

Exclusion criteria

• Transplant of any organ other than the kidney
• Current important infection
• Acute rejection within 12 weeks prior to inclusion

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)