Status:
COMPLETED
Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Transplant
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 biop...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00149903
Start Date
January 1 2005
Last Update
November 18 2016
Active Locations (1)
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1
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, China