Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
KAI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01576146
First received: April 5, 2012
Last updated: April 25, 2013
Last verified: April 2013
History of Changes

April 5, 2012
April 25, 2013
March 2012
February 2015   (final data collection date for primary outcome measure)
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. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01576146 on ClinicalTrials.gov Archive Site
  • Change in intact parathyroid hormone (iPTH) over the course of the treatment period [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change in corrected calcium over the course of the treatment period. [ Time Frame: 92 weeks ] [ Designated as safety issue: No ]
  • Change in phosphorus over the course of the treatment period. [ Time Frame: 92 weeks ] [ Designated as safety issue: No ]
  • Change in intact parathyroid hormone (iPTH) over the course of the treatment period [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
  • Change in corrected calcium over the course of the treatment period. [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
  • Change in phosphorus over the course of the treatment period. [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Open-label Study to Assess the Long-term Safety and Efficacy of AMG 416 (Also Known as KAI-4169) in Patients With Secondary Hyperparathyroidism
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

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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Secondary Hyperparathyroidism
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
Experimental: KAI-4169 (also known as AMG 416)
All eligible subjects will receive KAI-4169 (also known as AMG 416)
Intervention: Drug: KAI-4169 (also known as AMG 416)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
April 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject provides written informed consent.
  • Subject participated in parent study, KAI-4169-005

Exclusion Criteria:

  • Subject pregnant or nursing
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01576146
KAI-4169-005-01 (aka 20120334)
No
KAI Pharmaceuticals
KAI Pharmaceuticals
Not Provided
Study Director: William Goodman, MD Amgen
KAI Pharmaceuticals
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP