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

NCT ID: NCT00995163

Last Updated: 2012-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8020 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-01-31

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.

Conditions

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End Stage Renal Disease Hyperparathyroidism, Secondary

Keywords

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outcomes study hemodialysis CKD-MBD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tadao Akizawa, MD, PhD

Role: STUDY_CHAIR

Division of Nephrology, Department of Medicine, Showa University School of Medicine

Masafumi Fukagawa, MD, PhD

Role: STUDY_DIRECTOR

Division of Nephrology and Metabolism, Tokai University School of Medicine

Shunichi Fukuhara, MD, PhD

Role: STUDY_DIRECTOR

Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University

Locations

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Kobe, , Japan

Site Status

Countries

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Japan

References

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Kato C, Fujii N, Miyakoshi C, Asada S, Onishi Y, Fukuma S, Nomura T, Wada M, Fukagawa M, Fukuhara S, Akizawa T. Changes in 3-month mineral and bone disorder patterns were associated with all-cause mortality in prevalent hemodialysis patients with secondary hyperparathyroidism. BMC Nephrol. 2020 Oct 12;21(1):432. doi: 10.1186/s12882-020-02088-x.

Reference Type DERIVED
PMID: 33045994 (View on PubMed)

Yamamoto S, Kido R, Onishi Y, Fukuma S, Akizawa T, Fukagawa M, Kazama JJ, Narita I, Fukuhara S. Use of renin-angiotensin system inhibitors is associated with reduction of fracture risk in hemodialysis patients. PLoS One. 2015 Apr 13;10(4):e0122691. doi: 10.1371/journal.pone.0122691. eCollection 2015.

Reference Type DERIVED
PMID: 25874620 (View on PubMed)

Fukuhara S, Akizawa T, Fukagawa M, Onishi Y, Yamaguchi T, Hasegawa T, Kurokawa K. Mineral and bone disorders outcomes study for Japanese chronic kidney disease stage 5D patients: rationale and study design. Ther Apher Dial. 2011 Apr;15(2):169-75. doi: 10.1111/j.1744-9987.2010.00906.x. Epub 2011 Mar 2.

Reference Type DERIVED
PMID: 21426510 (View on PubMed)

Other Identifiers

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MBD-5D

Identifier Type: -

Identifier Source: org_study_id