Health Condition 1: N281- Cyst of kidney, acquired Health Condition 2: null- Hemodialysis Subjects With Secondary Hyperparathyroidism
Conditions
Interventions
Intervention1: Etelcalcetide (AMG 416): Etelcalcetide (AMG 416) IV TIW (3 times per week) and daily oral placebo tablets.
Treatment duration: 26-weeks
Control Intervention1: Cinacalcet tablets: Cinac
Sponsors
Amgen Technology Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 101 Subject has provided informed consent prior to performing any study-related activities/procedures. 102 Male or female subjects >= 18 years of age or older at the time of signing informed consent. 103 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. The Kt/V formula used for a subject must be the formula used during routine care prior to screening. 104 Dialysate calcium concentration must be >= 2.5 mEq/L (1.25 mmol/L) and stable for at least 4 weeks prior to screening laboratory assessments, and must remain >= 2.5 mEq/L (1.25 mmol/L) for the duration of the study. 105 Subject must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, within 2 weeks prior to randomization. 106 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 or for safety reasons. 107 Subject must have 1 screening predialysis serum cCa laboratory value >= 8.3 mg/dL measured within 2 weeks prior to randomization. 108 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. 109 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 or for safety reasons.
Exclusion criteria
Exclusion criteria: 201 Currently receiving treatment in another investigational device or drug study, or 202 Subject has received etelcalcetide in a prior clinical trial of etelcalcetide. 203 Subject has received cinacalcet during the 3 months prior to the first screening laboratory assessments. 204 Subject has known sensitivity to any of the products or components of either cinacalcet or etelcalcetide to be administered during dosing. 205 Subject has previously been randomized in this study. 206 Anticipated or scheduled parathyroidectomy during the study period. 207 Subject has received a parathyroidectomy within 6 months prior to dosing. 208 Anticipated or scheduled kidney transplant during the study period. 209 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. 210 Malignancy within the last 5 years of screening (except non-melanoma skin cancers or cervical carcinoma in situ). 211 Subject is unwilling or unable to avoid consumption of grapefruit juice during the study period. 212 Subject is pregnant or nursing, or planning to become pregnant or nurse during treatment or within 3 months after the last dose of etelcalcetide or 30 days after the last dose of cinacalcet. 213 Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with investigational product (IP) through 3 months after the last dose of IP. 214 Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes. 215 Subject has a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening. 216 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 times the upper limit of normal (ULN) at screening 217 Subject likely not 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 Investigatorâ??s knowledge. 218 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."
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is achievement of a 30% reduction from baseline in mean predialysis serum PTH level during the EAP of the study (EAP is defined as weeks 20 to 27, inclusive).The primary endpoint of the study is achievement of a 30% reduction from baseline in mean predialysis serum PTH level during the EAP of the study (EAP is defined as weeks 20 to 27, inclusive).Timepoint: during the EAP of the study (EAP is defined as weeks 20 to 27, inclusive). | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Achievement of a 50% reduction from baseline in mean predialysis serum PTH during the EAP (superiority) â?¢ Achievement of a 30% reduction from baseline in mean predialysis serum PTH during the EAP (superiority)Timepoint: during the EAP of the study (EAP is defined as weeks 20 to 27, inclusive).;Other Secondary Efficacy Endpoints â?¢ Percent change from baseline in mean predialysis serum cCa during the EAP â?¢ Achievement of mean predialysis serum P â?¤ 4.5 mg/dL during the EAPTimepoint: during the EAP of the study (EAP is defined as weeks 20 to 27, inclusive). | — |
Countries
China, Hong Kong, India, Malaysia, Republic of Korea, Taiwan
Contacts
Public ContactSonika Shah
Amgen Technology Private Limited
Outcome results
None listed