Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients

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Novartis

Status and phase

Completed
Phase 3

Conditions

Renal Transplant

Treatments

Drug: Mycophenolate sodium (enteric coated)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00149903
CERL080A2305

Details and patient eligibility

About

Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant, * treated with cyclosporine and corticosteroids as primary immunosuppression.

Exclusion criteria

* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ * Patients who have received an investigational drug within four weeks prior to study entry Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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