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Mineral and Bone Disorders Outcomes in Stage 5D of Chronic Kidney Disease (MBD-5D)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00995163
First received: October 14, 2009
Last updated: August 22, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
End Stage Renal Disease
Hyperparathyroidism, Secondary

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mineral and Bone Disorders Outcomes Study for Japanese Chronic Kidney Disease Stage 5D Patients (MBD-5D)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • all-cause mortality [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • cardiovascular mortality [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • hospitalization [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • parathyroid interventions [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • bone fracture [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • MBD management status [ Time Frame: at 1.5 and 3 years ] [ Designated as safety issue: No ]

Enrollment: 8020
Study Start Date: January 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients who are undergoing hemodialysis and who also have secondary hyperparathyroidism(2HPT)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995163

Locations
Japan
Kobe, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Investigators
Study Chair: Tadao Akizawa, MD, PhD Division of Nephrology, Department of Medicine, Showa University School of Medicine
Study Director: Masafumi Fukagawa, MD, PhD Division of Nephrology and Metabolism, Tokai University School of Medicine
Study Director: Shunichi Fukuhara, MD, PhD Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University
  More Information

No publications provided by Kyowa Hakko Kirin Company, Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT00995163     History of Changes
Other Study ID Numbers: MBD-5D
Study First Received: October 14, 2009
Last Updated: August 22, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyowa Hakko Kirin Company, Limited:
outcomes study
hemodialysis
CKD-MBD

Additional relevant MeSH terms:
Bone Diseases
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
 Musculoskeletal Diseases
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013