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

March 23, 2016 updated by: Novartis Pharmaceuticals

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)

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Cheras, Malaysia
        • Hospital Universiti Kebangsaan Malaysia
      • Kota Bharu, Malaysia
        • Hospital Raja Perempuan Zainab II
      • Kota Kinabalu, Malaysia
        • Hospital Queen Elizabeth
      • Kuala Lumpur, Malaysia
        • Hospital Kuala Lumpur
      • Kuantan, Malaysia
        • Hospital Tengku Ampuan Afzan
      • Kuching, Malaysia
        • Hospital Umum Sarawak
      • Pulau Pinang, Malaysia
        • Hospital Pulau Pinang
      • Selayang, Malaysia
        • Hospital Selayang
      • Serdang, Malaysia
        • Hospital Serdang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
With Gastro-Intestinal (GI) symptoms
Without GI symptoms

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 4-6 weeks
4-6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 23, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CERL080AMY02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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