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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001656
Receipt No. R000001997
Scientific Title Evaluation of efficacy and safety of active vitamin D treatment for secondary hyperparathyroidism in patients on maintenance hemodialysis; competitive study
Date of disclosure of the study information 2009/01/25
Last modified on 2014/09/29

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Basic information
Public title Evaluation of efficacy and safety of active vitamin D treatment for secondary hyperparathyroidism in patients on maintenance hemodialysis; competitive study
Acronym Randomized clinical trial with alfacalcidol versus maxacalcitol
Scientific Title Evaluation of efficacy and safety of active vitamin D treatment for secondary hyperparathyroidism in patients on maintenance hemodialysis; competitive study
Scientific Title:Acronym Randomized clinical trial with alfacalcidol versus maxacalcitol
Region
Japan

Condition
Condition secondary hyperparathyroidism(SHPT)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of study is to evaluate the effect of differential active vitamin D (alfacalcidol versus maxacalcitol) for SHPT in patients on maintenance hemodialysis(MHD).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The percentage achievement of recommendation value (60-180pg/mL) of intact parathyroid hormone(PTH).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 affacalcidol
Interventions/Control_2 maxacalcitol
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)Renal dysfunction: end-stage chronic kidney disease, require maintenance dialysis due to renal dysfunction
2) Expected survival time is more than 6 months
3)Fully informed consent was obtained
4)Intact PTH level 180pg/mL-500pg/mL
5)Serum P level 3.5-7.0mg/dL
6)Serum adjusted Ca 8.4-10.5mg/dL
Key exclusion criteria 1) Malignancy,malnutrition, active inflammatory or infectious disease
2)Severe heart failure and liver dysfunction
3)Pregnancy, during breast-feeding
4)Patients with allergy to affacalcidol and maxacalcitol
5)Primary hyperparathyroidism patients
6)Aluminum and Fe associated bone disease patients
7)Post parathyroidectomy patients, patients received percutaneous ethanol or vitamin D injection
8) Judged inappropriate for this study by the physicians
9)Parients who were recruited another clinical trial within 3 months
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu Honda
Organization Showa University School of Medicine
Division name Division of Nephrology , Department of Medicine
Zip code
Address 1-5-8, Hatanodai, Shinagawaku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Showa University Showa University School of Medicine
Division name Division of Nephrology Department of Medicine
Zip code
Address
TEL
Homepage URL
Email hondah@med.showa-u.ac.jp

Sponsor
Institute Division of Nephrology Department of Medicine Showa University School of Medicin
Institute
Department

Funding Source
Organization Division of Nephrology Department of Medicine Showa University School of Medicin
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 01 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 01 Month 25 Day
Last modified on
2014 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001997

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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