Clinical trial NCT01284257: Observational Registry Study of Renal Transplant Patients
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Kidney Transplant
Keywords: EC-MPS
MMF
kidney transplant
outcomes
mycophenolate sodium
mycophenolic acid (MPA)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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®.

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.


Eligibility 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.

Primary outcomes:
measure: Dosage of EC-MPS or MMF over time
timeFrame: 60 months
Secondary outcomes:
measure: Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications
timeFrame: 60 months
measure: The incidence of selected Adverse Events
timeFrame: 60 months
measure: Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death
timeFrame: 60 months
measure: Center Practices
timeFrame: 60 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco investigational site
state: California
city: Denver
country: United States
facility: Denver Investigational site
state: Colorado
city: Springfield
country: United States
facility: Springfield investigational site
state: Massachusetts
city: Detroit
country: United States
facility: Detroit investigational site
state: Michigan
city: New York
country: United States
facility: New York investigational site
state: New York
city: Philadelphia
country: United States
facility: PHILADELPHIA investigational site
state: Pennsylvania
city: Burlington
country: United States
facility: BURLINGTON investigational site
state: Vermont
city: Seattle
country: United States
facility: Seattle investigational site
state: Washington
Study officials:
References: