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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00529269
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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)

Condition or disease Intervention/treatment Phase
Renal Transplant Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal Symptoms
Study Start Date : December 2006
Primary Completion Date : June 2007


Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529269


Locations
Korea, Republic of
Novartis Investigative Site
Busan, Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Novartis Pharma Novartis
More Information

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00529269     History of Changes
Other Study ID Numbers: CERL080AKR03
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Renal Transplant Patients, GI symptom, Enteric-coated mycophenolate sodium

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action