EUCTR2013-000192-33-DKActive, not recruitingNot Applicable
A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in HemodialysisSubjects With Secondary Hyperparathyroidism
KAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)0 sites600 target enrollmentStarted: July 4, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Subject has provided informed consent.
- •- Subject is 18 years of age or older.
- •- Female subject must be willing to use highly effective contraception during the study and for 3 months after the last dose of investigational product (unless postmenopausal or surgically sterilized).
- •- Subject must be receiving maintenance hemodialysis 3 times weekly for at least 3 months, with adequate hemodialysis with a delivered Kt/V = 1.2 or urea reduction ratio (URR) = 65% within 4 weeks prior to screening laboratory assessments.
- •- Dialysate calcium concentration must be = 2.5 mEq/L and stable for at least 4 weeks prior to screening laboratory assessments, and must remain = 2.5 mEq/L for the duration of the study.
- •- Subject must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, within 2 weeks prior to randomization.
- •Subject currently receiving 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 must have one screening predialysis serum cCa laboratory value = 8.3 mg/dL measured within 2 weeks prior to randomization.
- •- A subject receiving calcium supplements must have had no more than a maximum dose change of 50% within 2 weeks prior to screening laboratory assessments and remain stable through randomization.
- •- A 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.
- •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 600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
- •- Currently receiving other investigational procedures while participating in this study are excluded.
- •- Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).
- •- Subject has received cinacalcet during the 3 months prior to the first screening laboratory assessments.
- •- Subject has known sensitivity to any of the products or components of either cinacalcet or AMG 416 to be administered during dosing.
- •- Subject has previously been randomized this study.
- •- Anticipated or scheduled parathyroidectomy during the study period.
- •- Subject has received a parathyroidectomy within 6 months prior to dosing.
- •- Anticipated or scheduled kidney transplant during the study period.
- •- 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.
- •- Malignancy within the last 5 years (except non-melanoma skin cancers or cervical carcinoma in situ).
- •- Subject is pregnant or nursing.
- •- Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes.
- •- Subject has a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months 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 < 2.5 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 evaluation, procedures or completion. This includes a subject who previously received cinacalcet, and in the opinion of the Investigator, is not a good candidate for future cinacalcet treatment.
Investigators
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