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Observational Registry Study of Renal Transplant Patients (MORE registry)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01284257
First received: January 25, 2011
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
The MORE Observational Study follows real-world renal transplant patients with the data resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing detailed clinical data, the study describes recent important changes in surveillance testing and drug therapy and relates these changes to short and long-term outcomes. Also, the study measures patient compliance over time and details the rationale for modifications of MPA dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide information on era changes in transplant practices and their impact on clinical outcome, new insights on optimizing regimens for discrete patient subsets and new perspectives on the optimal use of MPA therapy.

Condition
Kidney Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV, Non-interventional, Multi-center, Open-label, Prospective, Observational Study of the Safety, Effectiveness, Tolerability and Compliance of Immunosuppressive Regimens Using Mycophenolic Acid to Treat de Novo Renal Transplant Patients in Routine Clinical Practice

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Dosage of EC-MPS or MMF over time [ Time Frame: 60 months ]
    Dosage interruptions, discontinuations and switches between EC-MPS and MMF


Secondary Outcome Measures:
  • Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications [ Time Frame: 60 months ]
  • The incidence of selected Adverse Events [ Time Frame: 60 months ]
    e.g., viral infections, hematological events, glaucoma, malignancy, diabetes mellitus, cardiovascular events, bone-loss related events, GI events, hepatitis) and associated Serious Adverse Events (SAEs).

  • Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death [ Time Frame: 60 months ]
  • Center Practices [ Time Frame: 60 months ]
    The center practice will be described as observed. This includes the number of transplants performed per year per center, patient follow up frequency, performance of protocol biopsies, use of induction therapies and MPA monitoring.


Enrollment: 0
Actual Study Start Date: June 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Enteric coated mycophenolate sodium (EC-MPS) arm
Patients to whom EC-MPS is prescribed by their practitioner.
MMF arm
Patients to whom MMF is prescribed by their practitioner.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will enroll approximately 1,200 de novo (newly transplanted within 2 weeks) renal transplant patients from approximately 30-60 transplant centers across the United States. Patients should be consented prior to the first dose of MPA, +/- 14 days from the date of the transplant and be enrolled as soon as feasible after transplantation but not later than 2 weeks post-transplantation. Enrollment targets will be capped globally at 800 patients being treated with myfortic® and 400 patients being treated with CellCept®.
Criteria

Inclusion Criteria:

  • 18 years of age or older.
  • The de novo recipient of a cadaveric or living donor kidney transplant, within two weeks of transplantation.
  • Receiving mycophenolic acid (MPA) therapy of either myfortic® or CellCept®.
  • Able to provide informed consent.
  • Able to self-administer the ITAS compliance instrument (6 questions).

Exclusion Criteria:

  • The recipient of multiple organ grafts or prior non-kidney graft.
  • Enrolled or plans to enroll in an investigational clinical trial.
  • Not likely to have up to 5 year follow-up data available for this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284257

Locations
United States, California
San Francisco investigational site
San Francisco, California, United States
United States, Colorado
Denver Investigational site
Denver, Colorado, United States
United States, Massachusetts
Springfield investigational site
Springfield, Massachusetts, United States
United States, Michigan
Detroit investigational site
Detroit, Michigan, United States
United States, New York
New York investigational site
New York, New York, United States
United States, Pennsylvania
PHILADELPHIA investigational site
Philadelphia, Pennsylvania, United States
United States, Vermont
BURLINGTON investigational site
Burlington, Vermont, United States
United States, Washington
Seattle investigational site
Seattle, Washington, United States
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01284257     History of Changes
Other Study ID Numbers: CERL080AUS40
Study First Received: January 25, 2011
Last Updated: February 23, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
EC-MPS
MMF
kidney transplant
outcomes
mycophenolate sodium
mycophenolic acid (MPA)

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017