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 etelcalcetide administered by intravenous injection at the end of each hemodialysis session three times a week (TIW). The starting dose level was 5 mg; dose escalation was to proceed to 10 and 20 mg pending safety review of the prior cohort.

Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW).

Administered intravenously (IV) at the end of hemodialysis

Etelcalcetide

Administered intravenously at the end of hemodialysis

Placebo

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).

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

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

Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.

The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.

KAI Pharmaceuticals

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

Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.

Cohort 1: Placebo

Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.

Cohort 1: Etelcalcetide 5 mg

Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.

Cohort 2: Placebo

Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.

Cohort 2: Etelcalcetide 10 mg

Cohort 3: Placebo

Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.

Cohort 3: Etelcalcetide 5 mg

Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.

Total

Age, Continuous

Sex: Female, Male

Race

Ethnicity

Stratification Factor: Screening Serum Parathyroid Hormone (PTH)

Corrected calcium data were missing for 2 participants in Cohort 3.

Corrected Calcium

Phosphorus values were not collected at Baseline for Cohort 1; data were missing for 7 participants in Cohort 2 and 2 participants in Cohort 3.

Phosphorus

All randomized participants who received at least one 1 dose of investigational product (the modified intent-to-treat \[mITT\] population)

Study Director

The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.

Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase

Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase

Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase

Modified intent-to-treat population with available data

Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase

Modified intent-to-treat population with available data; Phosphorus data were not collected at baseline for participants in Cohort 1.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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