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

A Study of the Effect of Conversion to Enteric-Coated Mycophenolate Sodium (EC-MPS) on Quality of Life in Patients With Gastrointestinal (GI) Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation (MYQOL)

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).

Study Overview

• Status: Completed
• Conditions: Renal Transplant
• Intervention / Treatment: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS); Drug: Mycophenolate Mofetil (MMF)

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mycophenolate Mofetil (MMF); 250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.	Drug: Mycophenolate Mofetil (MMF); Other Names: Cellcept®
Experimental: 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.	Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS); Other Names: Myfortic®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mycophenolic Acid (MPA) Maintenance Treatment	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.	at week 13 (last visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS).	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).	At week 3 and week 13 (last visit)
Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI).	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).	At week 3 and week 13 (last visit)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Principal Investigator: Magdi Shehata, MBBCh, MD, FRCS, Director of Transplantation, Nottingham City Hospital, Nottingham

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: October 12, 2005
• First Submitted That Met QC Criteria: October 12, 2005
• First Posted (Estimate): October 14, 2005

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: QoL; MPA; GI Side Effects
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: CERL080AGB03; 2004-005071-42