Unique ID issued by UMIN | UMIN000031200 |
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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 |
Effect of polaprezinc vs zinc acetate dihydrate in Patients Receiving Hemodialysis With Zn deficiency; a single center, open label, randomized clinical study
Effect of polaprezinc vs zinc acetate dihydrate in Patients Receiving Hemodialysis With Zn deficiency; a single center, open label, randomized clinical study
Effect of polaprezinc vs zinc acetate dihydrate in Patients Receiving Hemodialysis With Zn deficiency; a single center, open label, randomized clinical study
Effect of polaprezinc vs zinc acetate dihydrate in Patients Receiving Hemodialysis With Zn deficiency; a single center, open label, randomized clinical study
Japan |
Patients on maintenance hemodialysis with zinc deficiency
Nephrology |
Others
NO
To inverstigate the effcicasy and safety of zinc acetate dihydrate (NOBELZIN) in patients on hemodialysis with zinc deficiency by prospective randomized study comaring polaprezinc.
Safety,Efficacy
Confirmatory
Not applicable
The cahnge in the serum levels of zinc 6 months after the trial
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
2
Treatment
Medicine |
zinc acetate dihydrate 25mg twice a day, for 24 weeks
Polaprezinc 75mg twice a day, for 24 weeks
20 | years-old | <= |
Not applicable |
Male and Female
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
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
110
1st name | Shingo |
Middle name | |
Last name | Hatakeyama |
Hirosaki University Graduate School of Medicine
Department of Urology
036-8562
Hirosaki
0172395091
shingorilla2@gmail.com
1st name | Shingo |
Middle name | |
Last name | Hatakeyama |
Dept. of Urology, Hirosaki University Graduate School of Medicine
Department of Urology
036-8562
Hirosaki
0172395091
shingorilla2@gmail.com
Hirosaki University Graduate School of Medicine
Oyokyo Kidney Research Institute
Other
Oyokyo Kidney Research Institute Aomori Hospital
Hirosaki University Graduate School of Medicine
5 Zaifu-chou
0172395091
coyama@hirosaki-u.ac.jp
NO
鷹揚郷腎研究所青森病院(青森県)
2018 | Year | 02 | Month | 08 | Day |
Published
91
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
2020 | Year | 01 | Month | 14 | Day |
The efficacy and safety of zinc acetate hydrate (ZAH) for zinc supplementation in patients on maintenance hemodialysis (MHD) remains unknown.
Completed
2018 | Year | 03 | Month | 10 | Day |
2018 | Year | 04 | Month | 11 | Day |
2018 | Year | 04 | Month | 11 | Day |
2020 | Year | 01 | Month | 14 | Day |
2018 | Year | 02 | Month | 08 | Day |
2020 | Year | 01 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035623
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