Back to results

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

Primary Purpose

Hyperparathyroidism, Secondary

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Placebo

Etelcalcetide

About this trial

This is an interventional treatment trial for Hyperparathyroidism, Secondary focused on measuring Clinical Trial, Phase 1, Renal Dialysis, Secondary Hyperparathyroidism, Parathyroid hormone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Etelcalcetide

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events

Secondary Outcome Measures

Percent Change From Baseline in Serum Parathyroid Hormone (PTH)

Percent Change From Baseline in Serum Corrected Calcium

Percent Change From Baseline in Ionized Calcium

Percent Change From Baseline in Serum Phosphorus

Percent Change From Baseline in Calcium Phosphorus Product

Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide

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

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

Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide

Full Information

NCT ID

NCT01134562

First Posted

May 28, 2010

Last Updated

May 26, 2017

Sponsor

KAI Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01134562

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

September 7, 2010 (undefined)

Primary Completion Date

April 2, 2011 (Actual)

Study Completion Date

April 2, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

KAI Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperparathyroidism, Secondary

Keywords

Clinical Trial, Phase 1, Renal Dialysis, Secondary Hyperparathyroidism, Parathyroid hormone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Etelcalcetide

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single IV injection.

Intervention Type

Drug

Intervention Name(s)

Etelcalcetide

Other Intervention Name(s)

KAI-4169, AMG 416

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Time Frame

For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Serum Parathyroid Hormone (PTH)

Time Frame

Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29

Title

Percent Change From Baseline in Serum Corrected Calcium

Time Frame

Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29

Title

Percent Change From Baseline in Ionized Calcium

Time Frame

Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).

Title

Percent Change From Baseline in Serum Phosphorus

Time Frame

Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).

Title

Percent Change From Baseline in Calcium Phosphorus Product

Time Frame

Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).

Title

Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide

Time Frame

Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).

Title

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

Time Frame

Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).

Title

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

Time Frame

Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).

Title

Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide

Time Frame

Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory Bell, MD

Organizational Affiliation

KAI Pharmaceuticals

Official's Role

Study Director

Facility Information:

City

Cypress

State/Province

California

Country

United States

City

Shreveport

State/Province

Louisiana

Country

United States

City

Houston

State/Province

Texas

Country

United States

City

Brisbane

State/Province

Queensland

Country

Australia

City

Melbourne

State/Province

Victoria

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs