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OpenTrials
Completed

NCT Number: NCT01300416

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

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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Key information

Conditions

Kidney Transplantation GI Symptoms Severity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universiti Kebangsaan Malaysia, Cheras, Malaysia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. To identify and evaluate quality of life and impact on symptom severity based on patients perception.

    Time frame: 4-6 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: PROGIS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 21, 2011
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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