Phase 2
N=87
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT01254565 ↗Enrolled (actual)
87
Serious AEs
12.8%
Results posted
Apr 2017
Primary outcome: Primary: Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase — 0.3; -19.4; 28.5; -49.4 percent change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Etelcalcetide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- KAI Pharmaceuticals
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase |
0.3; -19.4; 28.5; -49.4; 2.3; -33.0 | <0.0001 sig |
| SECONDARY Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase |
0.0; 33.3; 9.5; 76.2; 15.4; 53.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase |
0.0; 16.7; 4.8; 66.7; 7.7; 46.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase |
1.7; -7.3; -1.7; -13.0; 1.0; -6.0 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Mean Phosphorus (P) During the Efficacy Assessment Phase |
1.4; -2.4; 14.1; -7.3 | 0.2255 |
| SECONDARY Percent Change From Baseline in Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase |
-0.3; -11.0; 14.7; -12.6 | 0.0112 sig |
| SECONDARY Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase |
0.0; 0.0; 4.8; 47.6; 15.4; 46.2 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01254565). 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.