Status:
COMPLETED
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus
Lead Sponsor:
Novartis
Conditions:
Prevention of Acute Rejection After Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycop...
Eligibility Criteria
Inclusion
- First or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously;
- Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);
Exclusion
- Subjects expected to discontinue tacrolimus 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00171392
Start Date
March 1 2004
End Date
June 1 2005
Last Update
February 2 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.