Mineral and Bone Disorders Outcomes in Stage 5D of Chronic Kidney Disease

Study Overview
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Brief Summary
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The MBD-5D is a prospective observational study with a case-cohort and a cohort design. Eligible patients are receiving hemodialysis and have secondary hyperparathyroidism. The study's three goals are (1) to record the patients' characteristics, and variation in the patterns of their treatment; (2) to analyze factors associated with variation in those medical practice patterns; and (3) to identify practice patterns and other factors that affect hospitalization, mortality, and other patient-level outcomes.

Detailed Description
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The MBD-5D is a 3-year prospective observational study with a case-cohort and a cohort design. Eligible patients comprise all patients who are receiving hemodialysis at the participating facilities, and who also have secondary hyperparathyroidism(2HPT). The study has 3 goals: to record the characteristics of those patients and variation in the patterns of their treatment; to analyze factors associated with variation in those medical practice patterns; and to identify the practice patterns and other factors that affect hospitalization, mortality, and other patient-level outcomes. In the case-cohort study, the outcomes are relatively infrequent events (all-cause and cardiovascular mortality). The cohort study includes a randomly selected sample of 40% of all study participants; and the outcomes are hospitalization, parathyroid interventions, bone fracture, MBD management status, etc. Explanatory variables comprise medications and other factors likely to be associated with outcomes of dialysis and of 2HPT, and facility-level practice patterns.

Official Title
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Mineral and Bone Disorders Outcomes Study for Japanese Chronic Kidney Disease Stage 5D Patients (MBD-5D)

Conditions
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End Stage Renal Disease, Hyperparathyroidism, Secondary

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients receiving hemodialysis patients whose intact PTH concentration is at least 180 pg/mL (106 pg/mL for whole PTH) OR patients who are receiving intravenous active vitamin D sterols or oral active vitamin D sterols (falecalcitriol) Exclusion Criteria: patients have been undergoing hemodialysis for less than 3 months
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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | 3 years | 
| cardiovascular mortality |  | 3 years | 
| hospitalization |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parathyroid interventions |  | 3 years | 
| bone fracture |  | 3 years | 
| MBD management status |  | at 1.5 and 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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outcomes study, hemodialysis, CKD-MBD