UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031200
Receipt number R000035623
Scientific Title Effect of polaprezinc vs zinc acetate dihydrate in Patients Receiving Hemodialysis With Zn deficiency; a single center, open label, randomized clinical study
Date of disclosure of the study information 2018/02/08
Last modified on 2020/01/14 09:58:57

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Basic information

Public title

Effect of polaprezinc vs zinc acetate dihydrate in Patients Receiving Hemodialysis With Zn deficiency; a single center, open label, randomized clinical study

Acronym

Effect of polaprezinc vs zinc acetate dihydrate in Patients Receiving Hemodialysis With Zn deficiency; a single center, open label, randomized clinical study

Scientific Title

Effect of polaprezinc vs zinc acetate dihydrate in Patients Receiving Hemodialysis With Zn deficiency; a single center, open label, randomized clinical study

Scientific Title:Acronym

Effect of polaprezinc vs zinc acetate dihydrate in Patients Receiving Hemodialysis With Zn deficiency; a single center, open label, randomized clinical study

Region

Japan


Condition

Condition

Patients on maintenance hemodialysis with zinc deficiency

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To inverstigate the effcicasy and safety of zinc acetate dihydrate (NOBELZIN) in patients on hemodialysis with zinc deficiency by prospective randomized study comaring polaprezinc.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The cahnge in the serum levels of zinc 6 months after the trial

Key secondary outcomes

The change in Erythropoeisis stimulant agent resistance 6 months after the trial
The change in the serum levels of copper 6 months after the trial


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


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

zinc acetate dihydrate 25mg twice a day, for 24 weeks

Interventions/Control_2

Polaprezinc 75mg twice a day, for 24 weeks

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Hemodialysis patients, hemodialysis vintage >6months, with serum levels of zinc <70 microgram/dL
2.Age of >20 years old
3. Patients who are able to understand contents of this trial and give written informed consents

Key exclusion criteria

1. Hemodialysis vintage of <6 months
2. Already priscribed polaprenzinc or zinc acetate dihydrate
3. Unwillingness to participate in the study
4. Recent active infection
5. End stage of malignancy
6. Previous history of blood transfusion within at least 3 months before the trial
7. Severe liver damage
8. Drug/alcohol abuse
9. Patients who are not appropriate for the tial

Target sample size

110


Research contact person

Name of lead principal investigator

1st name Shingo
Middle name
Last name Hatakeyama

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Urology

Zip code

036-8562

Address

Hirosaki

TEL

0172395091

Email

shingorilla2@gmail.com


Public contact

Name of contact person

1st name Shingo
Middle name
Last name Hatakeyama

Organization

Dept. of Urology, Hirosaki University Graduate School of Medicine

Division name

Department of Urology

Zip code

036-8562

Address

Hirosaki

TEL

0172395091

Homepage URL


Email

shingorilla2@gmail.com


Sponsor or person

Institute

Hirosaki University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Oyokyo Kidney Research Institute

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Oyokyo Kidney Research Institute Aomori Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hirosaki University Graduate School of Medicine

Address

5 Zaifu-chou

Tel

0172395091

Email

coyama@hirosaki-u.ac.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

鷹揚郷腎研究所青森病院(青森県)


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

91

Results

The ZAH and PPZ groups had 44 and 47 patients, respectively. At 3 months, the change rate of serum zinc levels in the ZAH group was significantly higher than that in the PPZ group. Three months after the study, serum copper levels significantly decreased in the ZAH group, but not in the PPZ group. No significant differences were noted in anemia management in either group. ZAH was superior to PPZ in increasi

Results date posted

2020 Year 01 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The efficacy and safety of zinc acetate hydrate (ZAH) for zinc supplementation in patients on maintenance hemodialysis (MHD) remains unknown.

Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 03 Month 10 Day

Date of IRB

2018 Year 04 Month 11 Day

Anticipated trial start date

2018 Year 04 Month 11 Day

Last follow-up date

2020 Year 01 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 08 Day

Last modified on

2020 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035623


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name