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Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI Intolerance

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00150020
First received: September 6, 2005
Last updated: January 21, 2008
Last verified: January 2008
History of Changes
  Purpose

The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance renal transplant patients who experience gastrointestinal (GI) intolerance due to adverse events associated with mycophenolate mofetil (MMF) and were converted to EC-MPS.


Condition Intervention Phase
Renal Transplantation
 Drug: Enteric-coated mycophenolate sodium (EC-MPS)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Tolerability of Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients With GI Intolerance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) after conversion from MMF in maintenance renal transplant patients with GI intolerance [ Time Frame: within 3 months ]

Secondary Outcome Measures:
  • Safety of EC-MPS in combination with CsA-ME or tacrolimus as determined by incidence and severity of GI adverse events [ Time Frame: within 3 months ]
  • Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) [ Time Frame: within 1 month ]
  • Efficacy of EC-MPS in combination with CsA-ME or tacrolimus as measured by the incidence of biopsy-proven acute rejection [ Time Frame: within 3 months ]
  • Tolerability of EC-MPS in combination with CsA-ME or tacrolimus by comparing the two study groups [ Time Frame: after 3 months ]

Estimated Enrollment: 728
Study Start Date: October 2004
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. Males and females aged 18-75 years.
  2. Recipients of first or secondary cadaveric, living unrelated or living related kidney transplant.
  3. Recipients who are at least 4 weeks post renal transplantation.
  4. Patients currently receiving MMF (all dosages are allowed), cyclosporine microemulsion, its generic equivalent, cyclosporine USP (modified) or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks.
  5. Patients with mild and/or moderate GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.

Exclusion Criteria:

  1. Multi-organ patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed).
  2. Evidence of graft rejection, treatment of acute rejection or unstable renal function within 4 weeks prior to baseline visit.
  3. Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150020

Locations
United States, New Jersey
Novartis
East Hanover, New Jersey, United States
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: novartis
ClinicalTrials.gov Identifier: NCT00150020     History of Changes
Other Study ID Numbers: CERL080AUS02
Study First Received: September 6, 2005
Last Updated: January 21, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Renal/Kidney
Transplantation
MPA
EC-MPS
Renal Transplantation Patients with GI Intolerance with MMF

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013