A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

KAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)0 sites500 target enrollmentFebruary 26, 2013

ConditionsSecondary hyperparathyroidism in subjects with chronic kidney disease MedDRA version: 17.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disorders MedDRA version: 17.0Level: LLTClassification code 10020706Term: Hyperparathyroidism NOSSystem Organ Class: 10014698 - Endocrine disorders Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Secondary hyperparathyroidism in subjects with chronic kidney disease
Sponsor: KAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)
Enrollment: 500
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 26, 2013

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

KAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)

Eligibility Criteria

Inclusion Criteria

•Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
•Subject is 18 years of age or older.
•Female subjects who are post menopausal (post menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use highly effective contraception during the study and for 3 months after the last dose. Women of child\-bearing potential must have a negative serum pregnancy test within 2 weeks prior to the first dose of investigational product.
•Subject receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 4 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable doses for the duration of the study, except for adjustments allowed per protocol.
•Subject receiving phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable dose for the duration of the study, except for adjustments allowed per
•Subject receiving calcium supplements must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments and remain stable through randomization.
•Subject must be receiving hemodialysis 3 times weekly for at least 3 months and have adequate hemodialysis with a delivered Kt/V \= 1\.2 or urea reduction ratio (URR) \= 65% within 4 weeks prior to screening laboratory assessments.
•Dialysis prescription dialysate calcium concentration must be \= 2\.25 mEq/L and stable for at least 4 weeks prior to screening laboratory assessments, remain stable through randomization and remain \= 2\.25 mEq/L for the duration of the study.
•Subject must have 2 consecutive screening predialysis serum iPTH labs drawn on separate days within 2 weeks prior to randomization and the results of both must be \> 400 pg/mL. Enrollment of subjects with mean screening iPTH \> 1000 pg/mL will be limited to approximately 20% of subjects.
•Subject must have 2 consecutive screening predialysis serum cCa (Albumin corrected calcium concentration) labs drawn on separate days within 2 weeks prior to randomization and the results of both must be \= 8\.3 mg/dL.

Exclusion Criteria

•Subject currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
•Other investigational procedures while participating in this study are excluded.
•Anticipated or scheduled parathyroidectomy during the study period.
•Subject has received a parathyroidectomy within 3 months prior to dosing.
•Anticipated or scheduled kidney transplant during the study period.
•Subject has known sensitivity to any of the products or components to be administered during dosing.
•Subject has previously been randomized in this study
•Subject has received AMG 416 in a prior clinical trial of AMG 416 (also referred to
•as KAI\-4169\).
•Subject has received cinacalcet within the 4 weeks prior to screening labs