臨床研究等提出・公開システム

Feasibility Clinical Trial in PKR-001

Feasibility Clinical Trial in PKR-001

Kuro-o Makoto

Jichi Medical University

3311-1 Yakushiji Shimotsuke-shi, Tochigi

mkuroo@jichi.ac.jp

Terada Shimpei

KANEKA CORPORATION

2-3-18, Nakanoshima, Kita-ku Osaka

+81-50-3181-4126

Shimpei.Terada@kaneka.co.jp

Complete

July. 25, 2022

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

(1) Patients who fulfill the following conditions for at least one month prior to obtaining consent
-Taking more than 2 phosphorus adsorbents without any change in dosage and administration
-No change in diet therapy
-Patients have been receiving hemodialysis 3 times a week without any change in dialysis conditions (dialyzer, dialysate).
-If osteoporosis drugs or calcimimetics are prescribed, the patient is taking them without any change in dosage and administration.
(2) Patient has a serum phosphorus level of 6.0 mg/dL or higher within 1 month prior to obtaining consent
(3) Patients who have been on hemodialysis for more than 3 months
(4) Patients who are between 20 and 85 years of age on the date of consent

(1) Patients who have undergone parathyroid intervention [parathyroidectomy (PTx), percutaneous ethanol injection therapy (PEIT), etc.] within 1 year prior to obtaining consent or are scheduled to undergo such intervention during the trial
(2) Patients with NYHA classification III or IV cardiac disease
(3) Patients with AS severity classified as severe or very severe aortic stenosis
(4) Patients with severe carotid artery stenosis (stenosis rate >= 70%)
(5) Patients who are pregnant or lactating and wish to become pregnant during the study period
(6) Patients who are unable to consent to an appropriate contraceptive method
(7) Patients who are judged by the investigator/approved investigator to be unable to complete the observation during the study period
(8) Patients with allergies that are medically difficult to control, as determined by the investigator/approved investigator
(9) Other patients whom the investigator/approved investigator judges to be difficult to treat with the investigational device

Both

hyperphosphatemia

In the treatment group, PKR-001 is placed and treated at every hemodialysis session together with a dialyzer.

Serum phosphorus levels at 24 weeks
Safety (adverse events, Adverse Device Effect, bone density)

+81-3-3263-4801

May. 25, 2022

No

none