Trial Outcomes & Findings for Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis (NCT NCT01785875)

Last Updated: 2019-04-10

Results Overview

Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

891 participants

Primary outcome timeframe

From first dose until 30 days after last dose; the treatment period was 52 weeks.

Results posted on

2019-04-10

Participant Flow

This single-arm study was conducted at 205 centers in the US, Canada, Europe, Israel, Russian Federation and Australia. Participants were enrolled from 31 July 2013 to 9 June 2014. Participants who rolled over into another single-arm extension study 20130213 (NCT02102204) are reported as discontinuing the study due to protocol specified criteria.

This extension study enrolled participants from 1 of 3 parent studies: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970). In Studies 20120229 and 20120230, patients received either placebo or etelcalcetide 3 times a week (TIW) for up to 26 weeks; In Study 20120359, patients received 5 mg etelcalcetide TIW for 4 weeks.

Participant milestones

Participant milestones
Measure	20120229 / 20120230 Placebo Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120229 / 20120230 Etelcalcetide Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120359 Etelcalcetide Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Study STARTED	384	384	123
Overall Study Received Etelcalcetide	383	384	123
Overall Study COMPLETED	90	95	16
Overall Study NOT COMPLETED	294	289	107

Reasons for withdrawal

Reasons for withdrawal
Measure	20120229 / 20120230 Placebo Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120229 / 20120230 Etelcalcetide Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120359 Etelcalcetide Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Overall Study Withdrawal by Subject	41	34	36
Overall Study Lost to Follow-up	19	22	6
Overall Study Death	27	16	7
Overall Study Sponsor Decision	0	2	0
Overall Study Protocol Specified Criteria	207	214	55
Overall Study Missing	0	1	3

Baseline Characteristics

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etelcalcetide n=891 Participants All participants received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks during the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Age, Continuous	58.3 years STANDARD_DEVIATION 14.4 • n=5 Participants
Age, Customized < 65 years	577 participants n=5 Participants
Age, Customized ≥ 65 years	314 participants n=5 Participants
Sex: Female, Male Female	341 Participants n=5 Participants
Sex: Female, Male Male	550 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	29 participants n=5 Participants
Race/Ethnicity, Customized Black (or African American)	270 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	12 participants n=5 Participants
Race/Ethnicity, Customized White	567 participants n=5 Participants
Race/Ethnicity, Customized Other	12 participants n=5 Participants
Ethnicity Hispanic/Latino	122 participants n=5 Participants
Ethnicity Not Hispanic/Latino	769 participants n=5 Participants
Parathyroid Hormone (PTH) Level < 600 pg/mL	405 participants n=5 Participants
Parathyroid Hormone (PTH) Level 600 - ≤ 1000 pg/mL	221 participants n=5 Participants
Parathyroid Hormone (PTH) Level > 1000 pg/mL	228 participants n=5 Participants
Parathyroid Hormone (PTH) Level Missing	37 participants n=5 Participants
PTH Concentration	769.5 pg/mL STANDARD_DEVIATION 574.4 • n=5 Participants
Corrected Calcium	9.67 mg/dL STANDARD_DEVIATION 0.68 • n=5 Participants
Phosphorus	5.63 mg/dL STANDARD_DEVIATION 1.75 • n=5 Participants
Corrected Calcium Phosphorus Product (cCa x P)	54.36 mg²/dL² STANDARD_DEVIATION 17.17 • n=5 Participants

PRIMARY outcome

Timeframe: From first dose until 30 days after last dose; the treatment period was 52 weeks.

Population: All participants who received at least 1 dose of etelcalcetide.

Outcome measures

Outcome measures
Measure	20120229 / 20120230 Etelcalcetide n=384 Participants Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120229 / 20120230 Placebo n=383 Participants Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120359 Etelcalcetide n=123 Participants Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	Etelcalcetide Total n=890 Participants Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Number of Participants With Adverse Events (AEs) Any adverse event	337 participants	354 participants	108 participants	799 participants
Number of Participants With Adverse Events (AEs) Serious adverse events	142 participants	161 participants	53 participants	356 participants
Number of Participants With Adverse Events (AEs) Treatment-related adverse events	141 participants	215 participants	36 participants	392 participants
Number of Participants With Adverse Events (AEs) Treatment-related serious adverse events	5 participants	6 participants	2 participants	13 participants
Number of Participants With Adverse Events (AEs) AEs leading to discontinuation of etelcalcetide	11 participants	22 participants	8 participants	41 participants
Number of Participants With Adverse Events (AEs) Fatal adverse events	16 participants	27 participants	8 participants	51 participants

PRIMARY outcome

Timeframe: 52 weeks

Population: All participants who received at least 1 dose of etelcalcetide.

Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.

Outcome measures

Outcome measures
Measure	20120229 / 20120230 Etelcalcetide Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120229 / 20120230 Placebo n=890 Participants Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120359 Etelcalcetide Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	Etelcalcetide Total Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Alanine aminotransferase increase	—	1 participants	—	—
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Albumin decrease	—	9 participants	—	—
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Alkaline phosphatase increase	—	2 participants	—	—
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Aspartate aminotransferase increase	—	3 participants	—	—
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Bilirubin increase	—	1 participants	—	—
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Calcium (corrected) decrease	—	51 participants	—	—
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Calcium (corrected) increase	—	8 participants	—	—
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Phosphorus decrease	—	77 participants	—	—
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Potassium decrease	—	9 participants	—	—
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Potassium increase	—	69 participants	—	—
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Hemoglobin decrease	—	4 participants	—	—
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 Hemoglobin increase	—	1 participants	—	—

PRIMARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit

Population: Participants who received at least 1 dose of etelcalcetide and with a post-baseline antibody result.

A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.

Outcome measures

Outcome measures
Measure	20120229 / 20120230 Etelcalcetide n=384 Participants Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120229 / 20120230 Placebo n=369 Participants Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120359 Etelcalcetide n=123 Participants Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	Etelcalcetide Total n=876 Participants Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Number of Participants Who Developed Anti-etelcalcetide Antibodies	15 participants	10 participants	2 participants	27 participants

PRIMARY outcome

Timeframe: Baseline and Weeks 24 and 48

Population: Participants who received at least 1 dose of etelcalcetide and with available data at each time point (indicated by n)

Blood pressure (BP) values were taken post-hemodialysis assessments.

Outcome measures

Outcome measures
Measure	20120229 / 20120230 Etelcalcetide n=384 Participants Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120229 / 20120230 Placebo n=383 Participants Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120359 Etelcalcetide n=123 Participants Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	Etelcalcetide Total n=890 Participants Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Change From Baseline in Blood Pressure Diastolic BP Week 48 (n = 305, 317, 74, 696)	0.8 mmHg Standard Error 0.9	1.1 mmHg Standard Error 0.9	-2.6 mmHg Standard Error 1.7	0.6 mmHg Standard Error 0.6
Change From Baseline in Blood Pressure Systolic BP Week 24 (n = 329, 342, 104, 775)	4.5 mmHg Standard Error 1.4	4.0 mmHg Standard Error 1.5	-5.5 mmHg Standard Error 2.8	2.9 mmHg Standard Error 1.0
Change From Baseline in Blood Pressure Systolic BP Week 48 (n = 305, 317, 74, 696)	6.5 mmHg Standard Error 1.5	3.5 mmHg Standard Error 1.6	-6.8 mmHg Standard Error 3.0	3.8 mmHg Standard Error 1.0
Change From Baseline in Blood Pressure Diastolic BP Week 24 (n = 329, 343, 104, 776)	1.2 mmHg Standard Error 0.9	2.2 mmHg Standard Error 0.8	-5.1 mmHg Standard Error 1.5	0.8 mmHg Standard Error 0.6

SECONDARY outcome

Timeframe: Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)

Population: Participants with pre-dialysis PTH assessment at baseline and during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide.

The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.

Outcome measures

Outcome measures
Measure	20120229 / 20120230 Etelcalcetide n=332 Participants Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120229 / 20120230 Placebo n=341 Participants Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120359 Etelcalcetide n=106 Participants Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	Etelcalcetide Total n=779 Participants Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase	54.5 percentage of participants Interval 49.0 to 60.0	81.2 percentage of participants Interval 76.7 to 85.2	65.1 percentage of participants Interval 55.2 to 74.1	67.7 percentage of participants Interval 64.2 to 70.9

SECONDARY outcome

Timeframe: Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

Population: Participants with pre-dialysis PTH assessment at baseline and during EAP12

The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.

Outcome measures

Outcome measures
Measure	20120229 / 20120230 Etelcalcetide n=300 Participants Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120229 / 20120230 Placebo n=302 Participants Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120359 Etelcalcetide n=74 Participants Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	Etelcalcetide Total n=676 Participants Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12	53.3 percentage of participants Interval 47.5 to 59.1	82.5 percentage of participants Interval 77.7 to 86.6	63.5 percentage of participants Interval 51.5 to 74.4	67.5 percentage of participants Interval 63.8 to 71.0

SECONDARY outcome

Timeframe: Baseline and the efficacy assessment phase

Population: Participants with predialysis PTH assessment during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide

Outcome measures

Outcome measures
Measure	20120229 / 20120230 Etelcalcetide n=355 Participants Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120229 / 20120230 Placebo n=352 Participants Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	20120359 Etelcalcetide n=108 Participants Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	Etelcalcetide Total n=815 Participants Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
Percentage of Participants With PTH ≤ 300 pg/mL During the EAP	59.7 percentage of participants Interval 54.4 to 64.9	55.7 percentage of participants Interval 50.3 to 60.9	54.6 percentage of participants Interval 44.8 to 64.2	57.3 percentage of participants Interval 53.8 to 60.7

SECONDARY outcome

Timeframe: Week 46 to 53

Population: Participants with predialysis PTH assessment during the EAP12