Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus

Novartis

Status and phase

Completed

Phase 3

Conditions

Prevention of Acute Rejection After Kidney Transplantation

Treatments

Drug: Enteric-coated mycophenolate sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171392

CERL080AIT02

Details and patient eligibility

About

The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

First or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously;
Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);

Exclusion criteria

Subjects expected to discontinue tacrolimus therapy;

Patients with thrombocytopenia (<75,000/mm3), an absolute neutrophil count of <1,500/mm3 and/or leukopenia (<2,500/mm3), or anemia (hemoglobin <6 g/dl) at baseline;
Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia >2.5 mg/dL) or worsening renal function in the previous two months.