Neoplasms

Symptoms and General Pathology

All Conditions

Gland and Hormone Related Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

All Drugs and Chemicals

Hormones

Parathyroid Hormone

Participants received a single dose of placebo intravenous (IV) injection after hemodialysis.

Participants received a single dose of etelcalcetide by intravenous (IV) injection after hemodialysis.

Placebo

Single IV injection. The initial dose was 5 mg and dose escalation proceeded with subsequent doses of 10 mg, 20 mg, 40 mg and 60 mg.

Etelcalcetide

Gregory Bell, MD

The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.

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

A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Tolerability of Single Ascending Doses of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism

KAI Pharmaceuticals

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Pooled Placebo

Participants received a single dose of 5 mg etelcalcetide IV injection after hemodialysis.

Etelcalcetide 5 mg

Participants received a single dose of 10 mg etelcalcetide IV injection after hemodialysis.

Etelcalcetide 10 mg

Participants received a single dose of 20 mg etelcalcetide IV injection after hemodialysis.

Etelcalcetide 20 mg

Participants received a single dose of 40 mg etelcalcetide IV injection after hemodialysis.

Etelcalcetide 40 mg

Participants received a single dose of 60 mg etelcalcetide IV injection after hemodialysis.

Etelcalcetide 60 mg

Participants in Cohort 1 received single doses of 5 mg etelcalcetide and placebo in a crossover design, 7-14 days apart

Cohort 1: Placebo/Etelcalcetide 5 mg

Participants in Cohort 2 received single doses of 10 mg etelcalcetide and placebo in a crossover design, 7-14 days apart

Cohort 2: Placebo/Etelcalcetide 10 mg

Participants in Cohort 3 received single doses of 20 mg etelcalcetide and placebo in a crossover design, 7-14 days apart

Cohort 3: Placebo/Etelcalcetide 20 mg

Participants in Cohort 4 received a single dose of 40 mg etelcalcetide or placebo in a parallel group design.

Cohort 4: Placebo/Etelcalcetide 40 mg

Participants in Cohort 5 received a single dose of 60 mg etelcalcetide or placebo in a parallel group design.

Cohort 5: Placebo/Etelcalcetide 60 mg

Total

Age, Continuous

Sex: Female, Male

Race

Ethnicity

Study Director

Any adverse events

Serious adverse events

Withdrawal due to adverse events

Deaths due to adverse events

Treatment-related adverse events

All participants who were randomized and received any amount of study medication.

Number of Participants With Adverse Events

30 Minutes

1 Hour

4 Hours

8 Hours

18 Hours

24 Hours

32 Hours

42 Hours

48 Hours

56 Hours

Day 4-Discharge

Day 8

Day 15

Day 29

Participants received a single dose of placebo IV injection after hemodialysis.

Participants who were randomized and received any amount of study medication with available data at each time point. Only participants in Cohorts 4 and 5 had PTH assessed on days 8, 15 and 29.

Percent Change From Baseline in Serum Parathyroid Hormone (PTH)

Participants who were randomized and received any amount of study medication and with available data at each time point. Only participants in Cohorts 4 and 5 had serum corrected calcium assessed on days 8, 15 and 29.

Percent Change From Baseline in Serum Corrected Calcium

Participants who were randomized and received any amount of study medication with available data at each time point

Percent Change From Baseline in Ionized Calcium

Participants who were randomized and received any amount of study medication with available data at each time point.

Percent Change From Baseline in Serum Phosphorus

Percent Change From Baseline in Calcium Phosphorus Product

Participants who were randomized and received any amount of etelcalcetide.

Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide

Participants who were randomized and received any amount of etelcalcetide with available data.

Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide

Participants who were randomized and received any amount of etelcalcetide and with available data; The half-life associated with the terminal (log-linear) elimination phase values for the 40 mg dose level were not calculated due to poor log linear regression of the log concentration versus time profile during the terminal phase (r2 values \<0.7).

Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide

Participants who were randomized and received any amount of etelcalcetide and with available data.

Spots Global Cancer Trial Database for Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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