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

This study is currently recruiting participants.
Verified May 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01300416
First received: February 17, 2011
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition
Kidney Transplantation
GI Symptoms Severity

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify and evaluate quality of life and impact on symptom severity based on patients perception. [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2010
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
With Gastro-Intestinal (GI) symptoms
Without GI symptoms

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300416

Contacts
Contact: Novartis Pharmaceuticals +41-61-324-1111

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01300416     History of Changes
Other Study ID Numbers: CERL080AMY02
Study First Received: February 17, 2011
Last Updated: May 3, 2012
Health Authority: Malaysia: Ministry of Health Malaysia

Keywords provided by Novartis:
Kidney transplantation
mycophenolate sodium
EC-MPS
Health Related Quality of Life
GI symptoms
 Immunosuppressants
HRQL
PGWB
GIQLI

ClinicalTrials.gov processed this record on May 19, 2013