Phase 4
Completed N=134
Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation
Renal Transplant
Source: ClinicalTrials.gov NCT00239005 ↗
Enrolled (actual)
134
Serious AEs
12.4%
Results posted
Mar 2011
Primary outcomePrimary: Mycophenolic Acid (MPA) Maintenance Treatment — 47.06; 16.39 Percentage of Patients
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mycophenolic Acid (MPA) Maintenance Treatment |
47.06; 16.39 | — |
| SECONDARY Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS). |
-0.63; -0.32; -0.44; -0.25 | — |
| SECONDARY Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI). |
11.65; 6.08; 4.84; 1.77 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00239005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.