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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

February 17, 2011
May 3, 2012
July 2010
January 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01300416 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Measurement of Patient Reported Outcomes in Renal Transplant Patients With And Without Gastrointestinal (GI) Symptoms
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.
  • Kidney Transplantation
  • GI Symptoms Severity
Not Provided
  • With Gastro-Intestinal (GI) symptoms
  • Without GI symptoms
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Novartis Pharmaceuticals +41-61-324-1111
Malaysia
 
NCT01300416
CERL080AMY02
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Not Provided
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP