Clinical trial NCT00995163: Mineral and Bone Disorders Outcomes in Stage 5D of Chronic Kidney Disease
Official title: Mineral and Bone Disorders Outcomes Study for Japanese Chronic Kidney Disease Stage 5D Patients (MBD-5D)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Hyperparathyroidism, Secondary
Keywords: outcomes study
hemodialysis
CKD-MBD
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-15
Enrollment: 8020
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who are undergoing hemodialysis and who also have secondary hyperparathyroidism(2HPT)

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.

Eligibility 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

Primary outcomes:
measure: all-cause mortality
timeFrame: 3 years
measure: cardiovascular mortality
timeFrame: 3 years
measure: hospitalization
timeFrame: 3 years
Secondary outcomes:
measure: parathyroid interventions
timeFrame: 3 years
measure: bone fracture
timeFrame: 3 years
measure: MBD management status
timeFrame: at 1.5 and 3 years
Other outcomes:
Locations:
city: Kobe
country: Japan
Study officials:
affiliation: Division of Nephrology, Department of Medicine, Showa University School of Medicine
name: Tadao Akizawa, MD, PhD
role: STUDY_CHAIR
affiliation: Division of Nephrology and Metabolism, Tokai University School of Medicine
name: Masafumi Fukagawa, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University
name: Shunichi Fukuhara, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.