Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-Coated Mycophenolate Sodium After Equimolar Conversion From Mycophenolate Mofetil (MMF) in Patients With Renal Transplant

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171379

Purpose

The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.

Condition	Intervention	Phase
Prevention of Acute Rejection After Kidney Transplantation	Drug: Enteric-Coated Mycophenolate Sodium	Phase III

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, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Patients With Renal Transplant

Further study details as provided by Novartis:

Primary Outcome Measures:

Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula

Secondary Outcome Measures:

Incidence of biopsy proven acute rejection
Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)
Quality of life related to GI symptoms (GIQLI scale)
Full blood count
Gastrointestinal Adverse Events (check-list)

Estimated Enrollment:	210
Study Start Date:	March 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

First or second (single or double) deceased or living donor kidney transplant received at least six months previously;
- Immunosuppressive therapy with cyclosporin and mycophenolate mofetil (MMF);
- Receiving an MMF dose of <2/g/day because of any adverse event and/or altered laboratory test result attributed to MMF

Exclusion Criteria:

• Subjects expected to discontinue cyclosporin therapy;
- Patients with thrombocytopenia (<75,000/mm3), an absolute neutrophil count of <1,500/mm3 and/or leukopenia (<2,500/mm3), or anemia (hemoglobin <6 g/dl) at baseline;
- Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia >2.5 mg/dL) or worsening renal function in the previous two months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171379

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Study ID Numbers:	CERL080AIT01
Study First Received:	September 12, 2005
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00171379
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Novartis:

Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium.

Study placed in the following topic categories:

Mycophenolic Acid
Mycophenolate mofetil
Quality of Life

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009