NCT00149903CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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 Outcomes
- Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients
- Other variables of efficacy: chronic rejection, graft loss, death.
- Safety of EC-MPS as measured by incidence of adverse events and serious adverse events.
Investigators
Study Sites (1)
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