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

Phase 2

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: Etelcalcetide

• Registration Number: NCT01414114
• Lead Sponsor: KAI Pharmaceuticals

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

Not available

Study Timeline

• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Study Start: 2011-12-05
• Primary Completion: 2012-05-21
• Study Completion: 2012-05-21
• Disposition First Submitted: 2015-07-08
• Disposition First Submitted QC: 2015-07-08
• Disposition First Posted: 2015-07-30
• Status Verified: 2017-02
• Results First Submitted: 2017-02-27
• Results First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Results First Posted: 2017-04-11
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Etelcalcetide	Etelcalcetide	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.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period	Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)	Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period	Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)	The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period	The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)	The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Percent Change From Baseline in Corrected Calcium During the Efficacy Period	Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)	Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.
Percent Change From Baseline in Phosphorus During the Efficacy Period	Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)	Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.