Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

KAI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: Placebo; Drug: Etelcalcetide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254565

20120330 (Other Identifier)

KAI-4169-003

Details and patient eligibility

About

The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject provides written informed consent.
• Intact parathyroid hormone (PTH) at least 350 pg/mL.
• Corrected calcium at least 9.0 mg/dL.
• Hemoglobin at least 9.0 g/dL.
• Adequate hemodialysis three times per week.
• Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests.

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.
• Recent (3 months) parathyroidectomy.
• Serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater than two times the upper limit of normal at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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87 participants in 2 patient groups, including a placebo group

Etelcalcetide

Experimental group

Description:

Participants received etelcalcetide administered by intravenous injection at the end of each hemodialysis session three times a week (TIW). The starting dose level was 5 mg; dose escalation was to proceed to 10 and 20 mg pending safety review of the prior cohort.

Treatment:

Drug: Etelcalcetide

Placebo

Placebo Comparator group

Description:

Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW).

Treatment:

Drug: Placebo