Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Hyperparathyroidism, Secondary

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Renal Insufficiency

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Female Urogenital Diseases and Pregnancy Complications

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Hormones

Benzocaine

Parathyroid Hormone

Tannic Acid

Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.

Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.

Etelcalcetide

This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.

Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

A serious adverse event is an AE that met at least 1 of the following criteria:

* fatal
* life threatening
* required in-patient hospitalization or prolongation of existing hospitalization
* resulted in persistent or significant disability/incapacity
* congenital anomaly/birth defect
* other medically important serious event.

The relationship of each AE to study treatment was assessed by the investigator.

The following AE grading scale was used:

Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable.

The percentage of participants who maintained plasma parathyroid hormone (PTH) levels within the Kidney Disease Improving Global Outcomes (KDIGO) recommended range of not less than 2x the upper limit of normal (ULN) and not greater than 9x the ULN at months 6, 12, and 18, with the ULN based on the reference range of the assay used at the individual clinical site.

Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.

The percentage of participants with serum corrected calcium (cCa) reported for cumulative time intervals from day 1 through months 6, 12, and 18, using the participant's lowest recorded corrected calcium value during the time interval.

If serum albumin was less than 4.0 g/dL, serum calcium was corrected according to the following formula:

cCa (mg/dL) = total calcium (mg/dL) + (4 - albumin \[g/dL\])\*0.8. If serum albumin was \> 4.0 g/dL no correction was made.

The Common Terminology Criteria for Adverse Events (CTCAE) grades for laboratory parameter values were defined based on the upper/lower limit of normal from the local laboratories contracted by the study centers.

The number of participants who were binding antibody positive post-baseline with a negative or no result at baseline (where baseline for participants previously treated with etelcalcetide is Day 1 of the first study in which they were exposed to etelcalcetide and for participants previously treated with cinacalcet is the ending time point for study 20120360).

Amgen

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Age, Continuous

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Starting values are presented in this table, and are defined as the first non-missing measurement within the first 3 months on or after analysis day 1 (inclusive).

Albumin Corrected Calcium

Phosphorus

The full analysis set includes all participants who received at least 1 dose of etelcalcetide in the current study (20130213).

Study Director

Any adverse event

Serious adverse events

Treatment-related adverse events

Serious treatment-related adverse events

AEs leading to discontinuation of etelcalcetide

Fatal adverse events

Mild adverse events

Moderate adverse events

Severe adverse events

Life-threatening adverse events

Participants who received at least 1 dose of etelcalcetide in the current study (20130213).

Number of Participants With Adverse Events

Month 6

Month 12

Month 18

Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at each time point.

Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal

Percentage of Participants With Serum Phosphorus ≤ the ULN

Day 1 to Month 6

Day 1 to Month 12

Day 1 to Month 18

Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at the beginning of the time interval.

Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL

Increased Alanine Aminotransferase Grade 1 to 3

Increased Alkaline Phosphatase Grade 1 to 3

Increased Aspartate Aminotransferase Grade 1 to 3

Decreased Corrected Calcium Grade 1 to 3

Decreased Corrected Calcium Grade 1 to 4

Decreased ionized Calcium Grade 1 to 3

Decreased ionized Calcium Grade 1 to 4

Decreased Phosphorous Grade 1 to 3

Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters

Participants who received at least 1 dose of etelcalcetide in the current study with a post-baseline antibody result during this study

Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis	NCT02102204	Hyperparathyroi...	Etelcalcetide	18 Years - 110 Years	Amgen
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis	NCT02102204	Hyperparathyroi...	Etelcalcetide	18 Years - 110 Years	Amgen
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis	NCT02102204	Hyperparathyroi...	Etelcalcetide	18 Years - 110 Years	Amgen
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis	NCT02102204	Hyperparathyroi...	Etelcalcetide	18 Years - 110 Years	Amgen

Spots Global Cancer Trial Database for secondary hyperparathyroidism (shpt), chrominc kidney disease (ckd), hemodialysis