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

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. Identifier: NCT00150007
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 13, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Kidney Maintenance Transplant Drug: Enteric-coated Mycophenolate sodium (EC-MPS) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 335 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measurement of Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms (PROGIS)
Study Start Date : June 2004
Actual Primary Completion Date : June 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  1. Impact of GI symptoms on patients' perceptions of symptom severity, GI-specific HRQoL, and general HRQoL.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Other protocol-defined inclusion/exclusion criteria may apply.

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 identifier (NCT number): NCT00150007

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00150007     History of Changes
Other Study ID Numbers: CERL080A2407
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Kidney, maintenance transplant, GI complaints, patient reported outcome

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