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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01300416
Recruitment Status : Completed
First Posted : February 21, 2011
Last Update Posted : March 24, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease
Kidney Transplantation GI Symptoms Severity

Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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)
Study Start Date : July 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

With Gastro-Intestinal (GI) symptoms
Without GI symptoms

Primary Outcome Measures :
  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 Outcome Measures :
  1. To identify and evaluate quality of life and impact on symptom severity based on patients perception. [ Time Frame: 4-6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01300416

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

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01300416     History of Changes
Other Study ID Numbers: CERL080AMY02
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Kidney transplantation
mycophenolate sodium
Health Related Quality of Life
GI symptoms