Phase 3 double-blind study of KHK7580

Authors
Category Primary study
Registry of TrialsJapan Pharmaceutical Information Center
Year 2015
INTERVENTION: Intervention name : KHK7580 Dosage And administration of the intervention : Oral administration Control intervention name : KRN1493 INN of the control intervention : cinacalcet hydrochloride Dosage And administration of the control intervention : Oral administration CONDITION: Secondary hyperparathyroidism receiving hemodialysis PRIMARY OUTCOME: Efficacy SECONDARY OUTCOME: Efficacy 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
Epistemonikos ID: 3a3682ed273ef53466bf7c280f9ae52f582bb1ad
First added on: Aug 23, 2024