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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00995163
Acronym
MBD-5D
Enrollment
8020
Registered
2009-10-15
Start date
2008-01-31
Completion date
2011-01-31
Last updated
2012-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Hyperparathyroidism, Secondary

Keywords

outcomes study, hemodialysis, CKD-MBD

Brief summary

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

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.

Interventions

None listed

Sponsors

Kyowa Kirin Co., Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
all-cause mortality3 years
cardiovascular mortality3 years
hospitalization3 years

Secondary

MeasureTime frame
parathyroid interventions3 years
bone fracture3 years
MBD management statusat 1.5 and 3 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026