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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Kidney Transplantation GI Symptoms Severity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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With Gastro-Intestinal (GI) symptoms

No interventions assigned to this group

Without GI symptoms

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No