Phase 2 N=37 Treatment

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

Secondary Hyperparathyroidism

Bottom Line

View on ClinicalTrials.gov: NCT01414114 ↗

Enrolled (actual)

Serious AEs

8.1%

Results posted

Apr 2017

Primary outcome: Primary: Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period — -53.6; -55.6; -50.8 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Etelcalcetide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: KAI Pharmaceuticals
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period	-53.6; -55.6; -50.8	—
SECONDARY Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period	89; 95; 80	—
SECONDARY Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period	56; 76; 27	—
SECONDARY Percent Change From Baseline in Corrected Calcium During the Efficacy Period	-15.1; -13.0; -17.9	—
SECONDARY Percent Change From Baseline in Phosphorus During the Efficacy Period	-10.4; -7.7; -14.2	—

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01414114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.