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

Novartis

Status and phase: Terminated; Phase 4

Conditions: Renal Transplantation

Treatments: Drug: Enteric-coated Mycophenolate Acid (EC-MPA); Drug: Placebo MMF; Drug: Mycophenolate Mofetil (MMF); Drug: Placebo EC-MPA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658333

CERL080AUS67

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 2 patient groups

Enteric-coated Mycophenolate Acid

Experimental group

Description:

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.

Treatment:

Drug: Placebo MMF

Drug: Enteric-coated Mycophenolate Acid (EC-MPA)

Mycophenolate Mofetil

Active Comparator group

Description:

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.

Treatment:

Drug: Mycophenolate Mofetil (MMF)

Drug: Placebo EC-MPA