Observational Registry Study of Renal Transplant Patients (MORE registry)
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Purpose
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.
| Condition |
|---|
|
Kidney Transplant |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- Dosage of EC-MPS or MMF over time [ Time Frame: 60 months ] [ Designated as safety issue: No ]Dosage interruptions, discontinuations and switches between EC-MPS and MMF
- Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- The incidence of selected Adverse Events [ Time Frame: 60 months ] [ Designated as safety issue: No ]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 [ Time Frame: 60 months ] [ Designated as safety issue: No ]
- Center Practices [ Time Frame: 60 months ] [ Designated as safety issue: No ]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.
| Enrollment: | 947 |
| Study Start Date: | June 2007 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Enteric coated mycophenolate sodium (EC-MPS) arm
Patients to whom EC-MPS is prescribed by their practitioner.
|
|
MMF arm
Patients to whom MMF is prescribed by their practitioner.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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®.
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.
Contacts and Locations| United States, California | |
| San Francisco investigational site | |
| San Francisco, California, United States | |
| United States, Colorado | |
| Denver Investigational site | |
| Denver, Colorado, United States | |
| United States, Massachusetts | |
| Springfield investigational site | |
| Springfield, Massachusetts, United States | |
| United States, Michigan | |
| Detroit investigational site | |
| Detroit, Michigan, United States | |
| United States, New York | |
| New York investigational site | |
| New York, New York, United States | |
| United States, Pennsylvania | |
| PHILADELPHIA investigational site | |
| Philadelphia, Pennsylvania, United States | |
| United States, Vermont | |
| BURLINGTON investigational site | |
| Burlington, Vermont, United States | |
| United States, Washington | |
| Seattle investigational site | |
| Seattle, Washington, United States | |
More Information
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01284257 History of Changes |
| Other Study ID Numbers: | CERL080AUS40 |
| Study First Received: | January 25, 2011 |
| Last Updated: | January 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Novartis:
|
EC-MPS MMF kidney transplant |
outcomes mycophenolate sodium mycophenolic acid (MPA) |
Additional relevant MeSH terms:
|
Mycophenolic Acid Mycophenolate mofetil Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013