Unique ID issued by UMIN | UMIN000025478 |
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Receipt number | R000029320 |
Scientific Title | Clinical evaluation of the effect of ferric citrate hydrate in hemodialysis patients with renal anemia and hyperphosphatemia |
Date of disclosure of the study information | 2016/12/31 |
Last modified on | 2019/10/16 15:58:59 |
Clinical evaluation of the effect of ferric citrate hydrate in hemodialysis patients with renal anemia and hyperphosphatemia
The effect of ferric citrate hydrate in hemodialysis patients with renal anemia and hyperphosphatemia
Clinical evaluation of the effect of ferric citrate hydrate in hemodialysis patients with renal anemia and hyperphosphatemia
The effect of ferric citrate hydrate in hemodialysis patients with renal anemia and hyperphosphatemia
Japan |
End stage kidney disease with renal and iron deficiency anemia and hyperphosphatemia
Nephrology |
Others
NO
To evaluate the clinical effect of ferric citrate hydrate in hemodialysis patients
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
After 52 weeks
1. The rate of the accomplishment of the target of IP(3.5~6.0mg/dl)
2. The rate of the accomplishment of the target of Hb(10~12g/dl) and the average
3. Dose of ferric citrate hydrate
1. Fe Ferritin TSAT
2. cCa
3. Alb
4. hsCRP
5. BNP
6. Hb cyclimg
7. side effect
8. Dose of ESA
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
oral administration of ferric citrate hydrate for 52weeks
Not applicable |
Not applicable |
Male and Female
Iron deficiency anemia
TSAT<20%,Ferritin<100ng/ml
History of hypersensitivity to ferric citrate
Intake of other Iron-contained drugs
digestive hemorrhage or IBD patient
pregnancy or planned pregnancy
malignancy
physician's decision
80
1st name | |
Middle name | |
Last name | Kazuaki Soejima |
Saiseikai Kumamoto Hospital
kidney and urology center
Chikami 5-3-1,Minami-ku, Kumamoto
096-351-8000
hironobu-inoue@saiseikaikumamoto.jp
1st name | |
Middle name | |
Last name | Hironobu Inoue |
Saiseikai Kumamoto Hospital
kidney and urology center
Chikami 5-3-1,Minami-ku, Kumamoto
096-351-8000
hironobu-inoue@saiseikaikumamoto.jp
Saiseikai Kumamoto Hospital
Saiseikai Kumamoto Hospital
Self funding
NO
2016 | Year | 12 | Month | 31 | Day |
Partially published
Completed
2015 | Year | 12 | Month | 16 | Day |
2016 | Year | 04 | Month | 01 | Day |
2016 | Year | 04 | Month | 01 | Day |
2019 | Year | 12 | Month | 31 | Day |
2016 | Year | 12 | Month | 30 | Day |
2019 | Year | 10 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029320
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