Observational Registry Study of Renal Transplant Patients

Novartis Pharmaceuticals

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Kidney Transplant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

San Francisco investigational site

San Francisco, California, United States

Denver Investigational site

Denver, Colorado, United States

Springfield investigational site

Springfield, Massachusetts, United States

Detroit investigational site

Detroit, Michigan, United States

Outcomes

Primary Outcomes

Dosage of EC-MPS or MMF over time

Dosage interruptions, discontinuations and switches between EC-MPS and MMF

Time frame: 60 months

Secondary Outcomes

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

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).

Time frame: 60 months

Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death

Time frame: 60 months

Center Practices

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.

Time frame: 60 months

Data from ClinicalTrials.gov

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