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

End Stage Renal Disease Clinical Trial

— MBD-5D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995163
• Other study ID #: MBD-5D
• Status: Completed
• Phase: N/A
• First received: October 14, 2009
• Last updated: August 22, 2012
• Start date: January 2008
• Est. completion date: January 2011

Study information

• Verified date: August 2012
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8020
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Diseases
• End Stage Renal Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality		3 years	No
Primary	cardiovascular mortality		3 years	No
Primary	hospitalization		3 years	No
Secondary	parathyroid interventions		3 years	No
Secondary	bone fracture		3 years	No
Secondary	MBD management status		at 1.5 and 3 years	No