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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Renal Transplantation

Intervention / Treatment
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* Drug: Enteric-coated Mycophenolate Acid (EC-MPA)
* Drug: Mycophenolate Mofetil (MMF)
* Drug: Placebo MMF
* Drug: Placebo EC-MPA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enteric-coated Mycophenolate Acid<br>Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B. | Drug: Enteric-coated Mycophenolate Acid (EC-MPA)<br> <br> * Other names: myfortic®;Drug: Placebo MMF<br> <br> |
| Active Comparator: Mycophenolate Mofetil<br>Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B. | Drug: Mycophenolate Mofetil (MMF)<br> <br> * Other names: CellCept®;Drug: Placebo EC-MPA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Response (Yes/no) | The primary variable was the response (yes/no) with positive response being defined as an increase of 360 mg/day enteric-coated mycophenolate acid (MPA)from the baseline daily dose, tolerated and maintained for a 4 week duration until the end of the study (Week 6). Tolerability was defined as the overall assessment of improvement or no change in the intensity of physician assessed gastrointestinal (GI) symptoms at end of study as reported on the physician administered evaluation of GI symptomatology. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals | The average daily doses of enteric-coated mycophenolate acid (MPA) and mycophenolate mofetil (MMF) at baseline and during the last 2 weeks of treatment. 1000 mg MMF = 720 mg enteric-coated MPA (MPA equivalent dose). | Baseline and week 4 to week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Transplantation, Immunosuppression, Renal transplant recipients, Gastrointestinal symptoms associated with MMF therapy