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

NCT ID: NCT00150007

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30

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 outcomes when patients are converted to a EC-MPS-based immunosuppressive treatment.

Conditions

Kidney Maintenance Transplant

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis

Role: STUDY_DIRECTOR

Novartis

Other Identifiers

CERL080A2407

Identifier Type: -

Identifier Source: org_study_id