Observational Registry Study of Renal Transplant Patients

Withdrawn

• Conditions: Kidney Transplant

• Registration Number: NCT01284257
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dosage of EC-MPS or MMF over time	60 months	Dosage interruptions, discontinuations and switches between EC-MPS and MMF

Secondary Outcome Measures

Name	Time	Method
Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications	60 months
Center Practices	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.
The incidence of selected Adverse Events	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	60 months

Trial Locations

Locations (8)

Detroit investigational site; 🇺🇸 Detroit, Michigan, United States

Denver Investigational site; 🇺🇸 Denver, Colorado, United States

PHILADELPHIA investigational site; 🇺🇸 Philadelphia, Pennsylvania, United States

BURLINGTON investigational site; 🇺🇸 Burlington, Vermont, United States

Seattle investigational site; 🇺🇸 Seattle, Washington, United States

Springfield investigational site; 🇺🇸 Springfield, Massachusetts, United States

New York investigational site; 🇺🇸 New York, New York, United States

San Francisco investigational site; 🇺🇸 San Francisco, California, United States