Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil

NCT ID: NCT00400647

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-09-30

Brief Summary

This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium formulation(EC-MPS).

Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.

Conditions

Maintenance Kidney Transplant

Study Design

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

Study Groups

EC MPS

Up to 1440mg taken in two doses

Group Type: EXPERIMENTAL

Enteric-coated Mycophenolate sodium (EC-MPS)

Intervention Type: DRUG

Mycophenolate mofetil

250 mg or 500 mg in two equal doses

Group Type: ACTIVE_COMPARATOR

Mycophenolate mofetil

Intervention Type: DRUG

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS)

Intervention Type: DRUG

Mycophenolate mofetil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients who are recipients of a renal transplant.

2. Patients treated with an immunosuppressive regiment including MMF before recruitment.

3. Patients suffering from GI side effects related to MMF standard doses or patients treated with a reduced MMF dose to control the aforementioned GI side effects.

4. Patients 18 years or older.

5. Patients who have given written informed consent to participate in the study

6. Patients complying with all study requirements including completing questionnaires and attending to the three study visits.

Exclusion Criteria

1. Patients with GI symptoms assumed or known not to be caused by MPA therapy (eg. oral bisphosphonate induced, infectious diarrhea)

2. Acute rejection less than 1 week before recruitment.

3. Females of childbearing potential who are pregnant, planning to get pregnant and/or breast feeding or not willing to practice an approved method of birth control.

4. Presence of psychiatric disorder, such as schizophrenia or major depression, in the investigator's opinion, could interfere with study requirements.

5. Patients undergoing surgery due to acute illness or hospitalized.

6. Existence of any medical condition which, in the investigator's opinion based on anamnesis or medical records, could affect study completion, including but not limiting visual problems or cognitive deterioration.

7. Patients currently treated or who have been treated with any other study drug or treatment within 30 days prior to baseline visit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

Novartis

Basel, , Switzerland

Countries

Switzerland

References

Ortega F, Sanchez-Fructuoso A, Cruzado JM, Gomez-Alamillo JC, Alarcon A, Pallardo L, Morales JM, Oliver J, Guinea G; MYVIDA Study Group. Gastrointestinal quality of life improvement of renal transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium drugs or agents: mycophenolate mofetil and enteric-coated mycophenolate sodium. Transplantation. 2011 Aug 27;92(4):426-32. doi: 10.1097/TP.0b013e31822527ca.

Reference Type: RESULT

PMID: 21760569 (View on PubMed)

Other Identifiers

CERL080AES06

Identifier Type: -

Identifier Source: org_study_id