Status:
COMPLETED
Measurement of Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms (PROGIS)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Kidney Maintenance Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 outco...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT00150007
Start Date
June 1 2004
Last Update
September 13 2017
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