UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001656 |
|---|---|
| Receipt number | 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 14:37:40 |
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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
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
hondah@med.showa-u.ac.jp
Sponsor or person
Institute
Division of Nephrology Department of Medicine Showa University School of Medicin
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001997
