Observational Registry Study of Renal Transplant Patients

Kidney Transplant Clinical Trial

— MORE registry  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01284257
• Other study ID #: CERL080AUS40
• Status: Withdrawn
• Phase: N/A
• First received: January 25, 2011
• Last updated: February 23, 2017
• Start date: June 2007
• Est. completion date: May 2010

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant

Locations

Country	Name	City	State
United States	BURLINGTON investigational site	Burlington	Vermont
United States	Denver Investigational site	Denver	Colorado
United States	Detroit investigational site	Detroit	Michigan
United States	New York investigational site	New York	New York
United States	PHILADELPHIA investigational site	Philadelphia	Pennsylvania
United States	San Francisco investigational site	San Francisco	California
United States	Seattle investigational site	Seattle	Washington
United States	Springfield investigational site	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of EC-MPS or MMF over time	Dosage interruptions, discontinuations and switches between EC-MPS and MMF	60 months
Secondary	Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications		60 months
Secondary	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).	60 months
Secondary	Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death		60 months
Secondary	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.	60 months