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OpenTrials
Completed

NCT Number: NCT00529269

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

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)

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Drug

Primary outcomes

  1. 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 outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal Symptoms

Important dates

Study start
2006
Primary completion
2007
First posted
Sep 14, 2007
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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