Observational Registry Study of Renal Transplant Patients

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01284257

Acronym

MORE registry

Enrollment

Registered

2011-01-26

Start date

2007-06-30

Completion date

2010-05-31

Last updated

2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant

Keywords

EC-MPS, MMF, kidney transplant, outcomes, mycophenolate sodium, mycophenolic acid (MPA)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Dosage of EC-MPS or MMF over time	60 months	Dosage interruptions, discontinuations and switches between EC-MPS and MMF

Secondary

Measure	Time frame	Description
Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications	60 months	—
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	—
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.

Countries

United States

Outcome results