ORKEDIA Tablets Special Drug Use Results Survey -Survey on Long-Term Treatment in Patients with Hemodialysis-

ORKEDIA Tablets Special Drug Use Results Survey -Survey on Long-Term Treatment in Patients with Hemodialysis- - ORKEDIA Tablets Special Drug Use Results Survey -Survey on Long-Term Treatment in Patients with Hemodialysis-

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041834

Enrollment

2400

Registered

2020-09-27

Start date

2018-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary hyperparathyroidism (SHPT) on hemodialysis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Among patients with secondary hyperparathyroidism (SHPT) on hemodialysis, patients on hemodialysis who were naive to ORKEDIA(Evocalcet) were enrolled.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Safety 1.Situation related to occurrence of adverse reactions or infections 2.Situation related to occurrence of serious adverse events 3.Investigation of safety specifications 4.Investigation of other adverse events(upper gastrointestinal tract disorders, opacity of the lens or cataract) 5.Identification of factors considered to affect safety Efficacy 1.Time course of the concentrations of whole PTH, intact PTH, corrected serum Ca, serum P, corrected CaP product, and concentrations of serum ALP during the observation period 2.Efficacy rate based on the achievement of the concentrations of whole PTH, intact PTH, corrected serum Ca, and serum P in comparison with those in the guideline(note 1) during and after the observation period 3.Efficacy rate by background of patients 4.Identification of factors considered to affect the evaluation of efficacy note 1)Clinical Practice Guideline for the Management of Chronic Kidney Disease-Mineral and Bone Disorder (Therapeutic Apheresis and Dialysis 2013 17(3) p247 to 288)	—

Measure

Time frame

Safety 1.Situation related to occurrence of adverse reactions or infections 2.Situation related to occurrence of serious adverse events 3.Investigation of safety specifications 4.Investigation of other adverse events(upper gastrointestinal tract disorders, opacity of the lens or cataract) 5.Identification of factors considered to affect safety Efficacy 1.Time course of the concentrations of whole PTH, intact PTH, corrected serum Ca, serum P, corrected CaP product, and concentrations of serum ALP during the observation period 2.Efficacy rate based on the achievement of the concentrations of whole PTH, intact PTH, corrected serum Ca, and serum P in comparison with those in the guideline(note 1) during and after the observation period 3.Efficacy rate by background of patients 4.Identification of factors considered to affect the evaluation of efficacy note 1)Clinical Practice Guideline for the Management of Chronic Kidney Disease-Mineral and Bone Disorder (Therapeutic Apheresis and Dialysis 2013 17(3) p247 to 288)

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Countries

Japan

Contacts

Public ContactHiroshi Kuwazawa

Kyowa Kirin Co., Ltd. Pharmacovigilance Department

hiroshi.kuwazawa.wd@kyowakirin.com070-3143-9628

Outcome results