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
  Purpose

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.


Condition Intervention Phase
Secondary Hyperparathyroidism
Drug: KAI-4169 (also known as AMG 416)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KAI-4169 (also known as AMG 416)
All eligible subjects will receive KAI-4169 (also known as AMG 416)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subject pregnant or nursing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576146

Sponsors and Collaborators
KAI Pharmaceuticals
Investigators
Study Director: William Goodman, MD Amgen
  More Information

No publications provided

Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01576146     History of Changes
Other Study ID Numbers: KAI-4169-005-01 (aka 20120334)
Study First Received: April 5, 2012
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by KAI Pharmaceuticals:
Clinical Trial, Phase 2
Renal Dialysis
Secondary Hyperparathyroidism
Chronic kidney disease-mineral and bone disorder
Parathyroid hormone

Additional relevant MeSH terms:
Neoplasm Metastasis
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014