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)

Novartis Pharmaceuticals9 sites in 1 country101 target enrollmentJuly 2010

ConditionsKidney Transplantation GI Symptoms Severity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Transplantation
Sponsor: Novartis Pharmaceuticals
Enrollment: 101
Locations: 9
Primary Endpoint: 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.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

July 2012

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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.

Time Frame: 4-6 weeks