Clinical trial NCT00529269: Measurement of Patient Reported Outcomes in Korean Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms
Official title: Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplant
Keywords: Renal Transplant Patients, GI symptom, Enteric-coated mycophenolate sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)


Eligibility criteria: 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 /exclusion criteria may apply.

Primary outcomes:
measure: 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 outcomes:
measure: Impact of immunosuppressive-induced GI symptoms on patient's perception of symptom severity and HRQL.
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis Pharma
role: STUDY_CHAIR
References:
citation: Hwang HS, Hyoung BJ, Kim S, Oh HY, Kim YS, Kim JK, Kim YH, Kim YL, Kim CD, Shin GT, Yang CW. Improved gastrointestinal symptoms and quality of life after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients receiving tacrolimus. J Korean Med Sci. 2010 Dec;25(12):1759-65. doi: 10.3346/jkms.2010.25.12.1759. Epub 2010 Nov 24.