Overview

This trial is active, not recruiting.

Condition secondary hyperparathyroidism
Treatment kai-4169 (also known as amg 416)
Phase phase 2
Sponsor KAI Pharmaceuticals
Start date March 2012
End date February 2015
Trial size 30 participants
Trial identifier NCT01576146, KAI-4169-005-01 (aka 20120334)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All eligible subjects will receive KAI-4169 (also known as AMG 416)
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

Primary Outcomes

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

Secondary Outcomes

Measure
Change in intact parathyroid hormone (iPTH) over the course of the treatment period
time frame: 96 weeks
Change in corrected calcium over the course of the treatment period.
time frame: 92 weeks
Change in phosphorus over the course of the treatment period.
time frame: 92 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject provides written informed consent. - Subject participated in parent study, KAI-4169-005 Exclusion Criteria: - Subject pregnant or nursing

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by KAI Pharmaceuticals.