Phase 3 double-blind study of KHK7580

Phase 3 Study of KHK7580 (A Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects with Secondary Hyperparathyroidism Receiving Hemodialysis)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222961

Enrollment

600

Registered

2015-09-10

Start date

2015-09-10

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 receiving hemodialysis

Interventions

investigational material(s) Generic name etc : KHK7580 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Personally submitted written voluntary informed consent to participate in the study - Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening - Mean intact parathyroid hormone (PTH) level of > 240 pg/ml at screening, at 2 weeks and 1 week before the start of study treatment

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Efficacy Number and percentage of subjects in the evaluation period achieving a mean intact PTH level of >= 60 pg/mL and =<240 pg/mL	—

Secondary

Measure	Time frame
Efficacy Number and percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of >= 30% (percent change =<-30%) from baseline	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026