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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00150020

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 IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	Safety and Tolerability of Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients With GI Intolerance

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:

Males and females aged 18-75 years.
Recipients of first or secondary cadaveric, living unrelated or living related kidney transplant.
Recipients who are at least 4 weeks post renal transplantation.
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.
Patients with mild and/or moderate GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.

Exclusion Criteria:

Multi-organ patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed).
Evidence of graft rejection, treatment of acute rejection or unstable renal function within 4 weeks prior to baseline visit.
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

More Information

Publications indexed to this study:

Bolin P, Tanriover B, Zibari GB, Lynn ML, Pirsch JD, Chan L, Cooper M, Langone AJ, Tomlanovich SJ. Improvement in 3-month patient-reported gastrointestinal symptoms after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients. Transplantation. 2007 Dec 15;84(11):1443-51.

Responsible Party:	novartis ( novartis )
Study ID Numbers:	CERL080AUS02
Study First Received:	September 6, 2005
Last Updated:	January 21, 2008
ClinicalTrials.gov Identifier:	NCT00150020
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

Study placed in the following topic categories:

Mycophenolate mofetil

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009