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

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Novartis

Status and phase

Completed
Phase 4

Conditions

Kidney Maintenance Transplant

Treatments

Drug: Enteric-coated Mycophenolate sodium (EC-MPS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00150007
CERL080A2407

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* 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 criteria

* 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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