Clinical trial NCT00658333: 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
Official title: A Multicenter, Randomized, Double Blind, Double Dummy Controlled Study to Assess the Tolerability of an Increased Dose of Enteric Coated MPA After Conversion From MMF in Renal Transplant Recipients Who Required MMF Dose Reductions Due to Gastrointestinal Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: Renal Transplantation
Immunosuppression
Renal transplant recipients
Gastrointestinal symptoms associated with MMF therapy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Number of Participants With Response (Yes/no)
timeFrame: 6 weeks
Secondary outcomes:
measure: Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals
timeFrame: Baseline and week 4 to week 6
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novartis
state: Arizona
city: Los Angeles
country: United States
facility: Novartis
state: California
city: Los Angeles
country: United States
facility: Novartis
state: California
city: Los Angeles
country: United States
facility: Novartis
state: California
city: Orange
country: United States
facility: Novartis
state: California
city: San Diego
country: United States
facility: Novartis
state: California
city: San Francisco
country: United States
facility: Novartis
state: California
city: Aurora
country: United States
facility: Novartis
state: Colorado
city: Washington
country: United States
facility: Novartis
state: District of Columbia
city: Orlando
country: United States
facility: Novartis
state: Florida
city: New Orleans
country: United States
facility: Novartis
state: Louisiana
city: Portland
country: United States
facility: Novartis
state: Maine
city: Baltimore
country: United States
facility: Novartis
state: Maryland
city: Boston
country: United States
facility: Novartis
state: Massachusetts
city: Boston
country: United States
facility: Novartis
state: Massachusetts
city: Springfield
country: United States
facility: Novartis
state: Massachusetts
city: Detroit
country: United States
facility: Novarits
state: Michigan
city: New York
country: United States
facility: Novartis
state: New York
city: New York
country: United States
facility: Novartis
state: New York
city: New York
country: United States
facility: Novartis
state: New York
city: Charlotte
country: United States
facility: Novartis
state: North Carolina
city: Durham
country: United States
facility: Novartis
state: North Carolina
city: Greenville
country: United States
facility: Novartis
state: North Carolina
city: Winston-Salem
country: United States
facility: Novartis
state: North Carolina
city: Fargo
country: United States
facility: Novarits
state: North Dakota
city: Cleveland
country: United States
facility: Novartis
state: Ohio
city: Portland
country: United States
facility: Novartis
state: Oregon
city: Portland
country: United States
facility: Novartis
state: Oregon
city: Philadelphia
country: United States
facility: Novartis
state: Pennsylvania
city: Providence
country: United States
facility: Novartis
state: Rhode Island
city: Nashville
country: United States
facility: Novartis
state: Tennessee
city: Dallas
country: United States
facility: Novartis
state: Texas
city: Houston
country: United States
facility: Novartis
state: Texas
city: Temple
country: United States
facility: Novartis
state: Texas
city: Murray
country: United States
facility: Novartis
state: Utah
city: Burlington
country: United States
facility: Novartis
state: Vermont
city: Charlottesville
country: United States
facility: Novartis
state: Virginia
Study officials:
References: