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ACTIVE: Cinacalcet in Chinese CKD Hemodialysis Patients with SHPT

NCT03123406Phase 4

Key facts

Status: Completed
Start: Apr 2017
Primary completion: Apr 2019
Countries: 1
Sponsor: Kyowa Kirin
Modality: Small Molecules

Drugs: cinacalcet
Conditions: secondary hyperparathyroidism (SHPT)

Overview

Phase 4, open-label trial of cinacalcet in secondary hyperparathyroidism (SHPT) (3 arms), sponsored by Kyowa Kirin. Primary endpoint: Proportion of subjects reaching iPTH target at 32 weeks. Started Apr 2017; status: completed.

Design

3 arms

Study design: Non-randomizedOpen-label

Severe SHPT
iPTH > 900 pg/ml
Moderate SHPT
600 <= iPTH < 900 pg/ml
Mild SHPT
300 <= iPTH < 600 pg/ml

Who it enrols

Adult patients (18-75) with CKD on maintenance hemodialysis (>= 3 months) and secondary hyperparathyroidism (iPTH >= 300 pg/ml). Excludes patients with hypocalcemia (< 2.1 mmol/L), severe heart disease, history of GI bleeding, epilepsy, or recent calcimimetic use (within 6 months).

Endpoints

Primary

Proportion of subjects reaching iPTH target32 weeks

Secondary

Proportion of patients reaching Ca & P target simultaneously32 weeks
Proportion of patients with >= 30% reduction in iPTH level32 weeks
Change of Ca x P32 weeks
Change of alkaline phosphatase (ALP)32 weeks
Change of fibroblast growth factor 23 (FGF23)32 weeks
Adjustment (type or amount) of concomitant medications32 weeks
Proportional change of patients reaching targets in real-world period52 weeks

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