Open-label Study to Assess the Long-term Safety and Efficacy of AMG 416 (Also Known as KAI-4169) in Patients With Secondary Hyperparathyroidism

Secondary Hyperparathyroidism Clinical Trial

Official title:

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF KAI-4169 (ALSO KNOWN AS AMG 416)IN THE TREATMENT OF CHRONIC KIDNEY DISEASE-MINERAL AND BONE DISORDER IN PATIENTS WITH SECONDARY HYPERPARATHYROIDISM

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01576146
• Other study ID #: KAI-4169-005-01 (aka 20120334)
• Status: Terminated
• Phase: Phase 2
• First received: April 5, 2012
• Last updated: July 21, 2015
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2015
• Source: KAI Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of KAI-4169 in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis subjects.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject provides written informed consent.

• Subject participated in parent study, KAI-4169-005

Exclusion Criteria:

• Subject pregnant or nursing

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• KAI-4169 (also known as AMG 416)
KAI-4169 (also known as AMG 416) will be administered as an IV bolus three times each week for 92 weeks at dosages up to 15 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KAI Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety and tolerability of intravenous (IV) administration of KAI-4169 in hemodialysis subjects with secondary hyperparathyroidism (SHPT) as assessed by the type, frequency, severity, and reported relationship of treatment to adverse events.		96 weeks	Yes
Secondary	Change in intact parathyroid hormone (iPTH) over the course of the treatment period		96 weeks	No
Secondary	Change in corrected calcium over the course of the treatment period.		92 weeks	No
Secondary	Change in phosphorus over the course of the treatment period.		92 weeks	No