End Stage Renal DiseaseMBD-5DNCT00995163
Mineral and Bone Disorders Outcomes in Stage 5D of Chronic Kidney Disease
An observational study of End Stage Renal Disease and Hyperparathyroidism, Secondary, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease, Hyperparathyroidism, Secondary
- How many people
- 8,020 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2008to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who are undergoing hemodialysis and who also have secondary hyperparathyroidism(2HPT)
Who may be able to join
- 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)
Who cannot join
- patients have been undergoing hemodialysis for less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mineral and Bone Disorders Outcomes Study for Japanese Chronic Kidney Disease Stage 5D Patients (MBD-5D)
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.
Read the 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.
- Keywords
- outcomes study, hemodialysis, CKD-MBD
- Medical subject headings
- Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Chronic Kidney Disease-Mineral and Bone Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: 3 years
cardiovascular mortality
Measured: 3 years
hospitalization
Measured: 3 years
Secondary outcomes (3)
parathyroid interventions
Measured: 3 years
bone fracture
Measured: 3 years
MBD management status
Measured: at 1.5 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tadao Akizawa, MD, PhD, Study chair, Division of Nephrology, Department of Medicine, Showa University School of MedicineMasafumi Fukagawa, MD, PhD, Study director, Division of Nephrology and Metabolism, Tokai University School of MedicineShunichi Fukuhara, MD, PhD, Study director, Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995163
- Sponsor's protocol ID
- MBD-5D
- Acronym
- MBD-5D
- Status last verified
- Aug 2012
- First submitted
- 14 Oct 2009
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33045994Yamamoto 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.
PubMed 25874620Fukuhara 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.
PubMed 21426510
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mineral and Bone Disorders Outcomes Study for Japanese Chronic Kidney Disease Stage 5D Patients (MBD-5D)
- ClinicalTrials.gov ID
- NCT00995163
- Acronym / sponsor ID
- MBD-5D / MBD-5D
- Keywords
- outcomes study, hemodialysis, CKD-MBD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,020 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who are undergoing hemodialysis and who also have secondary hyperparathyroidism(2HPT)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- patients have been undergoing hemodialysis for less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all-cause mortality
Time frame: 3 years
cardiovascular mortality
Time frame: 3 years
hospitalization
Time frame: 3 years
3 secondary outcomes
parathyroid interventions
Time frame: 3 years
bone fracture
Time frame: 3 years
MBD management status
Time frame: at 1.5 and 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Derived from this study: PubMed 33045994Kato 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.
- Derived from this study: PubMed 25874620Yamamoto 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.
- Derived from this study: PubMed 21426510Fukuhara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadao Akizawa, MD, PhD study chair
Division of Nephrology, Department of Medicine, Showa University School of Medicine
Masafumi Fukagawa, MD, PhD study director
Division of Nephrology and Metabolism, Tokai University School of Medicine
Shunichi Fukuhara, MD, PhD study director
Department of Epidemiology and Healthcare Research, Graduate School of Medicine, Kyoto University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Hyperparathyroidism, Secondary, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00995163, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2012.