Renal Transplant
Conditions
Keywords
Renal Transplant Patients, GI symptom, Enteric-coated mycophenolate sodium
Brief summary
This study will evaluate the impact that GI complaints have on patient-reported outcomes and to determine if there is improvement in patient-reported outcomes when converted from mycophenolate mofetil (MMF) to Enteric-coated mycophenolate sodium (EC-MPS)
Interventions
DRUGEnteric-Coated Mycophenolate Sodium (EC-MPS)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Received kidney transplant at least 1 month prior to study enrollment * Receiving immunosuppressive regimen that includes MMF for at least 2 weeks prior to study enrollment * Eligible to convert to enteric-coated mycophenolate sodium (EC-MPS) because of GI complaints OR not currently experiencing GI complaints and stable on current immunosuppressive regimen * At least 18 years of age * Willing to provide written informed consent * Able to meet all study requirements including completing electronically-administered questionnaires and completing two study visits.
Exclusion criteria
* GI symptoms assumed or known not to be caused by MPA (Mycophenolic acid) therapy (e.g. oral biphosphonates 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 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. Other protocol-defined inclusion /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom severity is assessed by the GSRS (GI Symptom Rating Scale); Health-related Quality of Life (HRQL) is assessed by the GIQLI (GI Quality of Life) Index. | — |
Secondary
| Measure | Time frame |
|---|---|
| Impact of immunosuppressive-induced GI symptoms on patient's perception of symptom severity and HRQL. | — |
Countries
South Korea
Outcome results
None listed