Conditions: Secondary Hyperparathyroidism
Keywords: Clinical Trial, Phase 2 Renal Dialysis Secondary Hyperparathyroidism Chronic kidney disease-mineral and bone disorder Parathyroid hormone
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 37
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).

Detailed description:

Arms:
arm 1: Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.

Interventions: intervention 1: Etelcalcetide
Intervention descriptions: intervention 1: Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.

Protocol document: