Measurement of Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms (PROGIS)
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: August 26, 2005
Last updated: November 1, 2011
Last verified: November 2011
The purpose of this study is to assess the impact that GI complaints have on patient reported outcomes in renal transplant recipients and to determine if there is improvement in patient reported outcomes when patients are converted to a EC-MPS-based immunosuppressive treatment.
Kidney Maintenance Transplant
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Measurement of Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms (PROGIS)
Primary Outcome Measures:
- Improvement in Gastro intestinal (GI) symptom severity and health-related quality of life (HRQoL) in patients with GI complaints who are converted from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS)
Secondary Outcome Measures:
- Impact of GI symptoms on patients' perceptions of symptom severity, GI-specific HRQoL, and general HRQoL.
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||June 2005 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
- Received kidney transplant at least 1 month prior to study enrollment;
- Receiving immunosuppressive regimen that includes MMF for at least 2 weeks prior to study enrollment;
- Eligible to convert to EC-MPS 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.
- GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates induced, infectious diarrhea);
- Acute rejection < 1 week prior to study enrollment;
- Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception;
- Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
- Undergoing acute medical intervention or hospitalization;
- Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including but not limited to, visual problems or cognitive impairment
- Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.
Other protocol-defined inclusion/exclusion criteria may apply.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150007
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 26, 2005
||November 1, 2011
||Germany: Ethics Commission
Keywords provided by Novartis:
Kidney, maintenance transplant, GI complaints, patient reported outcome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs