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NCT00149903 Clinical Trial

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

Renal Transplant Clinical Trial

Official title:
Multicenter, Double-blind, Randomized, Parallel Group Study on Efficacy and Safety of Enteric-coated Mycophenolate Sodium vs. Mycophenolate Mofetil in de Novo Chinese Renal Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00149903
Other study ID # CERL080A2305
Secondary ID
Status Completed
Phase Phase 3
First received September 6, 2005
Last updated November 16, 2016
Start date January 2005

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date June 2006
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Mycophenolate sodium (enteric coated)

Locations
Country Name City State
China General Hospital, Friendship Hospital, Beijing, No 1 Hospital Peking University, Beijing China; Shanghai No 1 Hospital, Shanghai China; Changzheng Hospital, Shanghai, China; Shanghai Ruij Beijing

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of EC-MPS compared to MMF in Chinese patients as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant recipients.
Secondary Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients
Secondary Other variables of efficacy: chronic rejection, graft loss, death.
Secondary Safety of EC-MPS as measured by incidence of adverse events and serious adverse events.
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