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

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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

NCT00171379
CERL080AIT01

Details and patient eligibility

About

The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.

Enrollment

162 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

First or second (single or double) deceased or living donor kidney transplant received at least six months previously;

  • Immunosuppressive therapy with cyclosporin and mycophenolate mofetil (MMF);
  • Receiving an MMF dose of <2/g/day because of any adverse event and/or altered laboratory test result attributed to MMF

Exclusion criteria

• Subjects expected to discontinue cyclosporin 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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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