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

NCT00150007 | Completed Phase 4

• 1 other identifier: CERL080A2407
• Study Type: interventional
• Target: 335
• Locations: 0 countries
• Sites: N/A

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

Keywords

Kidney, maintenance transplant, GI complaints, patient reported outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Impact of GI symptoms on patients' perceptions of symptom severity, GI-specific HRQoL, and general HRQoL.

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: September 8, 2005
• Study Start: June 1, 2004
• Primary Completion: June 1, 2005
• Last Updated: September 13, 2017

Record last verified: 2011-11