UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038759 |
|---|---|
| Receipt number | R000044116 |
| Scientific Title | A randomized controlled non-blinded trial for Comparison of effectiveness between polaprezinc and Zinc acetate hydrate on hypozincemia in hemodialysis patients. |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2019/12/02 17:13:01 |
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Basic information
Public title
Comparison of effectiveness between polaprezinc and Zinc acetate hydrate on hypozincemia in hemodialysis patients.
Acronym
EPZA
Scientific Title
A randomized controlled non-blinded trial for Comparison of effectiveness between polaprezinc and Zinc acetate hydrate on hypozincemia in hemodialysis patients.
Scientific Title:Acronym
EPZA
Region
| Japan |
Condition
Condition
Zinc deficiency
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safty of 50mg/day zinc acetate hydrate and 150mg/day polaprezinc for dialysis patients with hypozincemia.
Basic objectives2
Others
Basic objectives -Others
copper deficiency
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy and safety for 6 months from the start of administration.
Key secondary outcomes
copper deficiency
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Zinc acetate hydrate(25mg/Tb) 1 tablet twice a day for 6 months.
Interventions/Control_2
Polaprezink(75mg/Tb) 1 tablet twice a day for 6 months.
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
| 40 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who undergo hemodialysis 3times a week for 2years or more
Patients whose blood zinc concentration before dialysis is less than 60microg/dL
Patients with written consent
Key exclusion criteria
Patient after enterectomy
Patients with peritoneal dialysis
Pregnant or breastfeeding
Patients allergic to zinc acetate hydrate or polaprezinc
Patients who are unable to carry out contraindications or contraception during the study period
Patients who are difficult to take orally
Patients with serum copper less than 30microg/dL
Patients judged to be inappropriate for inclusion in the study by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Kumagai |
Organization
Kenwakai Hospital
Division name
hemodialysis center
Zip code
395-8522
Address
1936,nakadaira,kanae,iidasi,nagano,395-8522,Japan
TEL
0265233116
k-hirasawa@kenwakai.or.jp
Public contact
Name of contact person
| 1st name | koh |
| Middle name | |
| Last name | hirasawa |
Organization
Kenwakai Hospital
Division name
hemodialysis center
Zip code
395-8522
Address
1936,nakadaira,kanae,iidasi,nagano,395-8522,Japan
TEL
0265233116
Homepage URL
k-hirasawa@kenwakai.or.jp
Sponsor or person
Institute
Kenwakai Hospital
hemodialysis center
Institute
Department
Personal name
Funding Source
Organization
Kenwakai Hospital
hemodialysis center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kenwakai Hospital
Address
1936,nakadaira,kanae,iidasi,nagano,395-8522,Japan
Tel
0265-23-3116
k-hirasawa@kenwakai.or.jp
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
| 2019 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 02 | Day |
Last modified on
| 2019 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044116
