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

NCT ID: NCT00239005

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30

Brief Summary

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).

Conditions

Renal Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mycophenolate Mofetil (MMF)

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

Group Type: ACTIVE_COMPARATOR

Mycophenolate Mofetil (MMF)

Intervention Type: DRUG

Enteric-Coated Mycophenolate Sodium (EC-MPS )

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

Group Type: EXPERIMENTAL

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Intervention Type: DRUG

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Intervention Type: DRUG

Mycophenolate Mofetil (MMF)

Intervention Type: DRUG

Other Intervention Names

Myfortic®; Cellcept®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis Pharmaceuticals

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Magdi Shehata, MBBCh, MD, FRCS

Role: PRINCIPAL_INVESTIGATOR

Director of Transplantation, Nottingham City Hospital, Nottingham

Locations

Novartis Investigative Site

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2004-005071-42

Identifier Type: -

Identifier Source: secondary_id

CERL080AGB03

Identifier Type: -

Identifier Source: org_study_id