Observational Registry Study of Renal Transplant Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Kidney Transplant

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enteric coated mycophenolate sodium (EC-MPS) arm<br>Patients to whom EC-MPS is prescribed by their practitioner. | |
| MMF arm<br>Patients to whom MMF is prescribed by their practitioner. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 
| Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death |  | 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. | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EC-MPS, MMF, kidney transplant, outcomes, mycophenolate sodium, mycophenolic acid (MPA)