Study of Immunosuppressive Therapy Toxicities in Kidney Transplant Recipients at Regional or Satellite Community Clinics

Study Overview
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Brief Summary
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This is a multicentre, observational, non-interventional, retrospective analysis by chart review.

Detailed Description
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This study will compare differences in patient and graft related outcomes in renal transplant recipients followed in regional transplant centers versus satellite clinics.

Official Title
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Regional Transplant Programs Study of Immunosuppressive Therapy Related Toxicities in Renal Transplant Recipients Managed at Regional or Satellite Community Nephrology Clinics

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Other: Chart Review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 months post transplant Patient had the current transplant during the period 1 July 1997 to no less than 18 months prior to chart review Patient is currently on tacrolimus/MMF or AZA - or cyclosporine/MMF or AZA based immunosuppressive therapy Patient is not a recipient of dual kidney or multi -organ transplant Patient has a functioning graft (i.e. patient does not require dialysis) Patient is recipient of a renal transplant including living or cadaveric, related or non-related, or pediatric en bloc kidneys, but excluding kidney-pancreas transplant recipients Patient received the current transplant at one of six identified regional transplant centers Patient is currently followed in a regional or satellite community based nephrology clinic

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 |
| --- | --- |
| 1. Community Based Clinics<br>Patient charts from community based nephrology clinics | Other: Chart Review<br>* Chart review of patients / graft outcome in renal transplant recipients<br>|
| 2. Regional Clinics<br>Patient charts from regional transplant clinics | Other: Chart Review<br>* Chart review of patients / graft outcome in renal transplant recipients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in renal function over 6-18 months estimated by change in serum creatinine and glomerular filtration rate (GFR) |  | 6, 12 and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of hyperlipidemia, hypertension, weight gain/central adiposity, hypertrichosis, alopecia, diabetes mellitus, bone disease and gingival hyperplasia |  | 6, 12 and 18 months | 
| Comparison of patients on cyclosporine-vs. tacrolimus-based immunoprophylaxis as well as community-based vs. regional transplant nephrology clinics in both incidence of toxicities and related clinical interventions |  | 6, 12 and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplantation, Tacrolimus, Immunosuppression