A study of AMG 416 in the treatment of secondary hyperparathyroidism in chronic kidney disease

• Conditions: Secondary 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]

• Registration Number: EUCTR2012-002805-23-AT
• Lead Sponsor: KAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-26
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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
protocol.
• 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.
• Subject agrees to not participate in another study of an investigational agent during the study.
• Subject’s legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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
• Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
• Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
• Subject history of malignancy within the last 5 years (except non-melanoma skin cancers, or cervical carcinoma in situ).
• Subject has a serious concurrent medical condition (eg, malignancy) likely to result in death during the next 12 months.
• Subject is pregnant or nursing.
• Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes.
• Subject’s screening 12-lead electrocardiogram (ECG) suggests unstable arrhythmia or other cardiac abnormality that could place the subject at increased risk, based upon the Investigator’s opinion.
• Subject has a history of poorly controlled hypertension.
• Subject has a history within the past 6 months of either angina pectoris with symptoms that occur at rest or minimal activity or a history of congestive heart failure (New York Heart Association Classification III or IV).
• Subject has a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
• Subject is receiving treatment for a seizure disorder or has a history of a seizure within the last 12 months prior to screening.
• Subject has had surgery (except minor surgery) within the last 8 weeks prior to screening.
• Subject has clinically significant abnormalities on prestudy clinical
examination or abnormalities on the most recent central laboratory tests during the screening period prior to randomization according to the Investigator including but not limited to the following:
• Serum albumin = 3.0 g/dL
• Serum magnesium < 1.5 mg/dL
• Serum transaminase (alanine transaminase [ALT] or Serum
glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST] or serum glutamic oxaloacetic transaminase [SGOT]) > 2.5 times the upper limit of normal (ULN) at screening
• Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and Investigator’s knowledge.
• History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study eva

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified