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

NCT00239005 | Completed Phase 4 Results

• 2 other identifiers: CERL080AGB032004-005071-42
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Keywords

QoL; GI Side Effects; MPA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS).

  At week 3 and week 13 (last visit)

• Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI).

  At week 3 and week 13 (last visit)

Study Arms (2)

Mycophenolate Mofetil (MMF)

ACTIVE COMPARATOR

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

Drug: Mycophenolate Mofetil (MMF)

Enteric-Coated Mycophenolate Sodium (EC-MPS )

EXPERIMENTAL

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)

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS) DRUG

Also known as: Myfortic®

Enteric-Coated Mycophenolate Sodium (EC-MPS )

Mycophenolate Mofetil (MMF) DRUG

Also known as: Cellcept®

Mycophenolate Mofetil (MMF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Magdi Shehata, MBBCh, MD, FRCS

  Director of Transplantation, Nottingham City Hospital, Nottingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 14, 2005
• Study Start: September 1, 2005
• Primary Completion: March 1, 2008
• Last Updated: March 30, 2017
• Results First Posted: March 24, 2011

Record last verified: 2017-02

Locations

GB (1)