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

Novartis

Status and phase: Completed; Phase 4

Conditions: Maintenance Kidney Transplant

Treatments: Drug: Enteric-coated Mycophenolate sodium (EC-MPS); Drug: Mycophenolate mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00400647

CERL080AES06

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

EC MPS

Experimental group

Description:

Up to 1440mg taken in two doses

Treatment:

Drug: Enteric-coated Mycophenolate sodium (EC-MPS)

Mycophenolate mofetil

Active Comparator group

Description:

250 mg or 500 mg in two equal doses

Treatment:

Drug: Mycophenolate mofetil