Clinical trial NCT01300416: Measurement of Patient Reported Outcomes in Renal Transplant Patients With And Without Gastrointestinal (GI) Symptoms
Official title: Open, Multi-centre, Non-interventional, Observational Study to Characterize the Impact That GI Complaints Have on Patient-reported Outcomes in Patients Who Have Had a Renal Transplant. Patients Will be Evaluated at Visit 1 and Then Again After 4 (+2) Weeks (Visit 2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
GI Symptoms Severity
Keywords: Kidney transplantation
mycophenolate sodium
EC-MPS
Health Related Quality of Life
GI symptoms
Immunosuppressants
HRQL
PGWB
GIQLI
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-02-21
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney transplanted Patients currently on MMF who have GI symptoms and will be converted to EC-MPS treatment and patients currently on MMF without GI symptoms who will continue with MMF therapy.

Brief summary: This study will access the GI complaints on patients reported outcomes and to determine the improvement in quality of life in patients.


Eligibility criteria: Inclusion Criteria:

* Patient received kidney transplant at least 1 month prior to study with MMF as a part of the treatment for at least 2 weeks.
* Eligible to convert to myfortic 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; and
* Able to meet all study requirements including completing paper questionnaires and completing two study visits.

Exclusion Criteria:

* GI symptoms assumed or known not be caused by MPA therapy and have recent acute rejection at least 1 week prior to the study.
* Breast-feeding or pregnant woman.
* Patients with psychiatric illness.
* Underlying acute medical intervention or hospitalization
* Receiving investigational drug within 30days prior to study.

Primary outcomes:
measure: To determine if GI symptoms severity and health related quality of life of patients has improved after being converted from MMF to EC-MPS due to GI complaints.
timeFrame: 4-6 weeks
Secondary outcomes:
measure: To identify and evaluate quality of life and impact on symptom severity based on patients perception.
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Hospital Universiti Kebangsaan Malaysia
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
city: Selayang
country: Malaysia
facility: Hospital Selayang
city: Serdang
country: Malaysia
facility: Hospital Serdang
Study officials:
References: