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

Phase 4

Completed

• Conditions: Renal Transplant

• Registration Number: NCT00529269
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate the impact that GI complaints have on patient-reported outcomes and to determine if there is improvement in patient-reported outcomes when converted from mycophenolate mofetil (MMF) to Enteric-coated mycophenolate sodium (EC-MPS)

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-06
• Study First Submitted: 2007-09-11
• Study First Submitted QC: 2007-09-12
• Study First Posted: 2007-09-14
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 enteric-coated mycophenolate sodium (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
• Able to meet all study requirements including completing electronically-administered questionnaires and completing two study visits.

Exclusion Criteria

• GI symptoms assumed or known not to be caused by MPA (Mycophenolic acid) 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Symptom severity is assessed by the GSRS (GI Symptom Rating Scale); Health-related Quality of Life (HRQL) is assessed by the GIQLI (GI Quality of Life) Index.

Secondary Outcome Measures

Name	Time	Method
Impact of immunosuppressive-induced GI symptoms on patient's perception of symptom severity and HRQL.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Seoul, Korea, Republic of