Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation

Novartis

Status and phase: Completed; Phase 4

Conditions: Renal Transplant

Treatments: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS); Drug: Mycophenolate Mofetil (MMF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00239005

2004-005071-42

CERL080AGB03

Details and patient eligibility

About

This open, multi-center randomized controlled study is designed to investigate the quality of life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse events after converting to enteric-coated mycophenolate sodium (EC-MPS).

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Received kidney transplant
2. Receiving immunosuppressive regimen that includes MMF
3. Patients with GI side effects on standard MMF doses or patients on reduced dose MMF with existing but tolerated/controlled GI side effects.
4. At least 18 years of age
5. Willing to provide written informed consent
6. Able to meet all study requirements including completing questionnaires and completing four study visits.

Exclusion criteria

1. Patients with GI symptoms assumed or known not to be caused by medroxyprogesterone acetate (MPA) therapy (e.g. oral bisphosphonate induced, infectious diarrhea)
2. Acute rejection < 1 week prior to study enrollment
3. Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating and who is unwilling to use effective means of contraception
4. Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements
5. Undergoing acute medical intervention or hospitalization
6. Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including, but not limited to, visual problems or cognitive impairment.
7. Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.

Additional protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Mycophenolate Mofetil (MMF)

Active Comparator group

Description:

250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.

Treatment:

Drug: Mycophenolate Mofetil (MMF)

Enteric-Coated Mycophenolate Sodium (EC-MPS )

Experimental group

Description:

Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.

Treatment:

Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)