Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients

Novartis

Status and phase: Completed; Phase 3

Conditions: Renal Transplantation

Treatments: Drug: Prednisone; Drug: Enteric-coated mycophenolate sodium (EC-MPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00413920

CERL080AFR05

Details and patient eligibility

About

This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated to receive either EC-MPS or steroids in combination with EC-MPS. Patients of both treatment groups will receive monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.

Enrollment: 222 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary donor kidney transplant
• Panel reactive antibody (PRA) ≤ 20%

Exclusion criteria

• Multi-organ transplantation including dual kidneys or previous transplant with any other organ different from kidney
• Non-heart beating donor or kidney from a non-compatible donor

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

Without Steroids

Experimental group

Description:

Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.

Treatment:

Drug: Enteric-coated mycophenolate sodium (EC-MPS)

With Steroids

Active Comparator group

Description:

Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.

Treatment:

Drug: Enteric-coated mycophenolate sodium (EC-MPS)

Drug: Prednisone