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 has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00171379

First received: September 12, 2005

Last updated: February 1, 2011

Last verified: February 2011

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolic acid Mycophenolate sodium Mycophenolate mofetil hydrochloride Mycophenolate mofetil

U.S. FDA Resources

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)


Enrollment:	162
Study Start Date:	March 2004
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis	Novartis

More Information


Responsible Party:	Novartis External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00171379 History of Changes
Other Study ID Numbers:	CERL080AIT01
Study First Received:	September 12, 2005
Last Updated:	February 1, 2011

Keywords provided by Novartis:


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

Additional relevant MeSH terms:


Mycophenolic Acid Mycophenolate mofetil Antibiotics, Antineoplastic Antineoplastic Agents Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 17, 2017

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