Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

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Amgen

Status and phase

Completed
Phase 3

Conditions

Hyperparathyroidism, Secondary

Treatments

Drug: Etelcalcetide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01785875
2012-002808-41 (EudraCT Number)
20120231
KAI-4169-008 (Other Identifier)

Details and patient eligibility

About

This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

Enrollment

891 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
  • Subject must complete the treatment and follow-up period, or have been discontinued for rising intact parathyroid hormone (iPTH), from an AMG 416 phase 3 parent study prior to the start of dosing in this study: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970).
  • Subject agrees to not participate in another study of an investigational agent during the study.
  • Other Inclusion Criteria may apply

Exclusion criteria

  • Currently receiving treatment in another investigational device or drug study.
  • Currently receiving other investigational procedures while participating in this study.
  • Subject has known sensitivity to any of the products or components to be administered during dosing.
  • Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.

Other Exclusion Criteria may apply

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

891 participants in 1 patient group

Etelcalcetide
Experimental group
Description:
Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Treatment:
Drug: Etelcalcetide

Trial contacts and locations

209

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Data sourced from clinicaltrials.gov

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