Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder

KAI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: Etelcalcetide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01414114

20120331 (Other Identifier)

KAI-4169-005

Details and patient eligibility

About

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).

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects provides written informed consent
• Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL
• Hemoglobin ≥ 8.5 g/dL
• Serum transaminases (alanine transaminase [ALT], aspartate transaminase [AST]) less than 2.5 times the upper limit of normal
• Adequate hemodialysis three times per week

Exclusion criteria

• History or symptomatic ventricular dysrhythmias
• History of angina pectoris or congestive heart failure
• History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
• History of or treatment for seizure disorder within the last 12 months
• Postdialysis systolic blood pressure > 180 mmHg or diastolic blood pressure > 90 mmHg
• Serum magnesium below the lower limit of normal at screening

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Etelcalcetide

Experimental group

Description:

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.

Treatment:

Drug: Etelcalcetide