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

Phase 4

Completed

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

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).

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Patients with GI symptoms assumed or known not to be caused by medroxyprogesterone acetate (MPA) therapy (e.g. oral bisphosphonate induced, infectious diarrhea)
Acute rejection < 1 week prior to study enrollment
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
Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements
Undergoing acute medical intervention or hospitalization
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.
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.

Arm && Interventions

Group	Intervention	Description
Mycophenolate Mofetil (MMF)	Mycophenolate Mofetil (MMF)	250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
Enteric-Coated Mycophenolate Sodium (EC-MPS )	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.

Primary Outcome Measures

Name	Time	Method
Mycophenolic Acid (MPA) Maintenance Treatment	at week 13 (last visit)	The primary assessment was based on the percentage of patients who were maintained at week 13 on a dose at least one dose equivalent greater than at baseline (visit 2/week 1). A dose equivalent was defined as EC-MPS 180 mg/day or MMF 250 mg/day.

Secondary Outcome Measures

Name	Time	Method
Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS).	At week 3 and week 13 (last visit)	The GSRS is a 15-item instrument designed to assess the impact of upper and lower GI symptoms. There are five subscales: reflux, diarrhea, constipation, abdominal pain, and indigestion-each of which produces a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). A higher score represents greater impairment of quality of life due to GI symptoms (range from 1 to 7).
Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI).	At week 3 and week 13 (last visit)	Health-related quality of life (HRQoL)was assessed by the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI also has five different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) producing a total score of the 36 items. Lower scores represent more dysfunction. A higher score represents a better quality of life (range from 0 to 144).