Status:
TERMINATED
A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Recipients of first or second cadaveric, living unrelated or living related kidney transplant.
- Patients on a reduced daily dose (500mg to 1500mg) of MMF with existing but tolerable and controlled gastrointestinal symptoms.
- Recipients who are at least 4 weeks post renal transplantation with stable renal function.
- Exclusion criteria:
- Multi organ transplant or previous transplant with organ other than kidney
- History of GI disorder prior to transplant
- Evidence of GI disorder induced by infection, underlying medical condition, or con med other than MMF
- Modification of GI med or MMF dose within one week
- Evidence of graft rejection, treatment of acute rejection, unstable renal function within 1 week of (baseline) visit
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00658333
Start Date
March 1 2008
End Date
March 1 2009
Last Update
August 7 2012
Active Locations (37)
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1
Novartis
Phoenix, Arizona, United States, 85012
2
Novartis
Los Angeles, California, United States, 90033
3
Novartis
Los Angeles, California, United States, 90057
4
Novartis
Los Angeles, California, United States, 90095