Clinical trial NCT00239005: Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplant
Keywords: QoL
GI Side Effects
MPA
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-14
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Mycophenolic Acid (MPA) Maintenance Treatment
timeFrame: at week 13 (last visit)
Secondary outcomes:
measure: Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS).
timeFrame: At week 3 and week 13 (last visit)
measure: Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI).
timeFrame: At week 3 and week 13 (last visit)
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Director of Transplantation, Nottingham City Hospital, Nottingham
name: Magdi Shehata, MBBCh, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References: