Phase 1
N=28
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Hyperparathyroidism, Secondary
Bottom Line
View on ClinicalTrials.gov: NCT01134562 ↗Enrolled (actual)
28
Serious AEs
2.6%
Results posted
Jan 2018
Primary outcome: Primary: Number of Participants With Adverse Events — 2; 1; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo (Drug); Etelcalcetide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- KAI Pharmaceuticals
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
2; 1; 1; 1; 4; 2 | — |
| SECONDARY Percent Change From Baseline in Serum Parathyroid Hormone (PTH) |
1.381; -63.179; -68.890; -70.021; -72.435; -77.471 | — |
| SECONDARY Percent Change From Baseline in Serum Corrected Calcium |
0.024; 0.106; -2.883; -2.589; -0.572; 1.951 | — |
| SECONDARY Percent Change From Baseline in Ionized Calcium |
-0.118; 0.234; -2.940; -0.122; -0.934; -3.300 | — |
| SECONDARY Percent Change From Baseline in Serum Phosphorus |
6.453; 2.080; -0.255; 5.498; 9.024; 5.608 | — |
| SECONDARY Percent Change From Baseline in Calcium Phosphorus Product |
6.658; 2.064; -2.929; 2.755; 8.239; 7.789 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide |
145; 263; 511; 726; 1140 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide |
1110; 2820; 4920; 9560; 15700 | — |
| SECONDARY Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide |
3180; 5280; 16800; 43800 | — |
| SECONDARY Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide |
64.6; 50.9; 71.7; 60.2; 68.0 | — |
Summary
The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.
Eligibility Criteria
Inclusion Criteria
- Subjects provides written informed consent.
- Intact parathyroid hormone (iPTH) ≥ 400 pg/mL (≥ 300 and < 1200 pg/ml for Cohorts 1-3).
- Serum corrected calcium ≥ 9.0 mg/dL
- Receiving hemodialysis three times per week for at least 3 months and had adequate hemodialysis with a delivered Kt/V (dialyzer clearance of urea * dialysis time/ volume of distribution of urea) ≥ 1.2 or urea reduction ratio (URR)
≥ 65%.
- 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
Data sourced from ClinicalTrials.gov (NCT01134562). 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.