Measurement of Patient Reported Outcomes in Renal Transplant Patients With And Without Gastrointestinal (GI) Symptoms

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01300416

Acronym

PROGIS

Enrollment

101

Registered

2011-02-21

Start date

2010-07-31

Completion date

2012-07-31

Last updated

2016-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GI Symptoms Severity, Kidney Transplantation

Keywords

Kidney transplantation, mycophenolate sodium, EC-MPS, Health Related Quality of Life, GI symptoms, Immunosuppressants, HRQL, PGWB, GIQLI

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	4-6 weeks

Secondary

Measure	Time frame
To identify and evaluate quality of life and impact on symptom severity based on patients perception.	4-6 weeks

Countries

Malaysia

Outcome results