Trial Outcomes & Findings for Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) (NCT NCT03299244)

NCT ID: NCT03299244

Last Updated: 2021-04-30

Results Overview

Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

637 participants

Primary outcome timeframe

Baseline and the efficacy assessment phase (EAP; defined as weeks 20 to 27, inclusive).

Results posted on

2021-04-30

Participant Flow

This study was conducted at 84 centers including mainland China (43 centers), Hong Kong (2 centers), India (12 centers), South Korea (11 centers), Malaysia (4 centers), and Taiwan (12 centers). Participants were enrolled from 15 May 2018 to 12 September 2019.

Participants were randomized 1:1 to receive etelcalcetide or cinacalcet. Randomization was stratified by screening serum parathyroid hormone (PTH) level (\< 900 pg/mL, ≥ 900 pg/mL) (\< 95.40 pmol/L, ≥ 95.40 pmol/L), screening serum corrected calcium (cCa) measured by the central laboratory (≥ 9.0 mg/dL, \< 9.0 mg/dL) (≥ 2.25 mmol/L, \< 2.25 mmol/L), and country (China versus non-China).

Participant milestones

Participant milestones
Measure	Cinacalcet Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Overall Study STARTED	317	320
Overall Study Received Treatment	315	318
Overall Study COMPLETED	270	282
Overall Study NOT COMPLETED	47	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Cinacalcet Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Overall Study Withdrawal by Subject	34	29
Overall Study Decision by Sponsor	4	5
Overall Study Death	9	4

Baseline Characteristics

Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cinacalcet n=317 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=320 Participants Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Total n=637 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 12.9 • n=5 Participants	52.2 years STANDARD_DEVIATION 13.4 • n=7 Participants	51.8 years STANDARD_DEVIATION 13.1 • n=5 Participants
Age, Customized 18 - 64 years	264 Participants n=5 Participants	262 Participants n=7 Participants	526 Participants n=5 Participants
Age, Customized 65 - 74 years	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Age, Customized 75 - 84 years	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Age, Customized ≥ 85 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	138 Participants n=5 Participants	142 Participants n=7 Participants	280 Participants n=5 Participants
Sex: Female, Male Male	179 Participants n=5 Participants	178 Participants n=7 Participants	357 Participants n=5 Participants
Race/Ethnicity, Customized Asian Indian	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	262 Participants n=5 Participants	270 Participants n=7 Participants	532 Participants n=5 Participants
Race/Ethnicity, Customized Other	36 Participants n=5 Participants	31 Participants n=7 Participants	67 Participants n=5 Participants
Stratification Factor: Screening Intact Parathyroid Hormone (iPTH) < 900 pg/mL	128 Participants n=5 Participants	131 Participants n=7 Participants	259 Participants n=5 Participants
Stratification Factor: Screening Intact Parathyroid Hormone (iPTH) ≥ 900 pg/mL	189 Participants n=5 Participants	189 Participants n=7 Participants	378 Participants n=5 Participants
Stratification Factor: Screening Corrected Calcium (cCa) < 9 mg/dL	62 Participants n=5 Participants	64 Participants n=7 Participants	126 Participants n=5 Participants
Stratification Factor: Screening Corrected Calcium (cCa) ≥ 9 mg/dL	255 Participants n=5 Participants	256 Participants n=7 Participants	511 Participants n=5 Participants
Stratification Factor: Country/Region China	189 Participants n=5 Participants	191 Participants n=7 Participants	380 Participants n=5 Participants
Stratification Factor: Country/Region Non-China	128 Participants n=5 Participants	129 Participants n=7 Participants	257 Participants n=5 Participants
Intact Parathyroid Hormone Level	1299.01 pg/mL STANDARD_DEVIATION 830.99 • n=5 Participants	1299.91 pg/mL STANDARD_DEVIATION 853.82 • n=7 Participants	1299.46 pg/mL STANDARD_DEVIATION 841.87 • n=5 Participants
Corrected Calcium Level	9.71 mg/dL STANDARD_DEVIATION 0.75 • n=5 Participants	9.73 mg/dL STANDARD_DEVIATION 0.90 • n=7 Participants	9.72 mg/dL STANDARD_DEVIATION 0.83 • n=5 Participants
Phosphorus Level	6.67 mg/dL STANDARD_DEVIATION 1.61 • n=5 Participants	6.62 mg/dL STANDARD_DEVIATION 1.55 • n=7 Participants	6.64 mg/dL STANDARD_DEVIATION 1.58 • n=5 Participants
Corrected Calcium Phosphorus Product (cCa x P)	64.70 mg²/dL² STANDARD_DEVIATION 16.39 • n=5 Participants	64.41 mg²/dL² STANDARD_DEVIATION 16.33 • n=7 Participants	64.56 mg²/dL² STANDARD_DEVIATION 16.35 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and the efficacy assessment phase (EAP; defined as weeks 20 to 27, inclusive).

Population: Full analysis set; participants with iPTH data during the EAP.

Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory.

Outcome measures

Outcome measures
Measure	Cinacalcet n=278 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=295 Participants Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis	66.2 percentage of participants	71.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive).

Population: Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (non-responder imputation).

Predialysis intact parathyroid hormone levels were measured by a central laboratory.

Outcome measures

Outcome measures
Measure	Cinacalcet n=317 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=320 Participants Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase	41.6 percentage of participants	59.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive)

Population: Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP.

Predialysis intact parathyroid hormone levels were measured by a central laboratory.

Outcome measures

Outcome measures
Measure	Cinacalcet n=317 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=320 Participants Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis	58.0 percentage of participants	66.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline and the efficacy assessment phase (weeks 20 - 27, inclusive)

Population: Full analysis set; participants with available data

Predialysis corrected calcium was measured by a central laboratory.

Outcome measures

Outcome measures
Measure	Cinacalcet n=277 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=295 Participants Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase	-8.00 percent change Standard Error 0.50	-10.69 percent change Standard Error 0.53

SECONDARY outcome

Timeframe: Efficacy assessment phase (weeks 20 - 27, inclusive)

Population: Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders.

Predialysis serum phosphorus was measured by a central laboratory.

Outcome measures

Outcome measures
Measure	Cinacalcet n=317 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=320 Participants Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase	26.2 percentage of participants	29.1 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug to end of study; up to 26 weeks + 30 days.

Population: Participants in the safety analysis set with at least 1 post-baseline cCa value. The safety analysis set includes all randomized participants who received at least 1 dose of study drug.

Corrected calcium was measured by the central laboratory.

Outcome measures

Outcome measures
Measure	Cinacalcet n=310 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=317 Participants Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study	245 Participants	273 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug to end of study; up to 26 weeks + 30 days.

Population: Participants in the safety analysis set with at least 1 post-baseline cCa value.

Corrected calcium was measured by the central laboratory.

Outcome measures

Outcome measures
Measure	Cinacalcet n=310 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=317 Participants Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study	194 Participants	241 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug to end of study; up to 26 weeks + 30 days.

Population: Participants in the safety analysis set with at least 1 post-baseline cCa value.

Corrected calcium was measured by the central laboratory.

Outcome measures

Outcome measures
Measure	Cinacalcet n=310 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=317 Participants Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study	61 Participants	109 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.

Population: Safety analysis set

Common symptoms of hypocalcemia (diminished blood calcium) include paresthesias (fingertips, toes, or perioral), fatigue, muscle cramps, irritability or anxiety, tetany (eg, carpopedal spasm, laryngospasm), Chvostek's sign, seizures, and prolonged QT interval.

Outcome measures

Outcome measures
Measure	Cinacalcet n=315 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=318 Participants Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study	15 Participants	35 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.

Population: Safety analysis set participants assigned to etelcalcetide with a post-baseline antibody result.

Developing antibody incidence is defined as participants who were binding antibody positive post-baseline with a negative or no result at baseline.

Outcome measures

Outcome measures
Measure	Cinacalcet n=307 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Number of Participants Who Developed Antibodies to Etelcalcetide	18 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.

Population: Safety analysis set

An adverse event is defined as any untoward medical occurrence in a clinical study participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. The investigator assessed whether each adverse event was possibly related to study drug. A serious adverse event is defined as an adverse event that met at least 1 of the following serious 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

Outcome measures

Outcome measures
Measure	Cinacalcet n=315 Participants Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=318 Participants Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Number of Participants With Treatment-emergent Adverse Events Any treatment-emergent adverse event (TEAE)	303 Participants	306 Participants
Number of Participants With Treatment-emergent Adverse Events Serious adverse events	61 Participants	53 Participants
Number of Participants With Treatment-emergent Adverse Events TEAEs leading to discontinuation of study drug	15 Participants	9 Participants
Number of Participants With Treatment-emergent Adverse Events Treatment-related TEAEs	243 Participants	250 Participants
Number of Participants With Treatment-emergent Adverse Events Treatment-related serious adverse events	4 Participants	4 Participants
Number of Participants With Treatment-emergent Adverse Events Fatal adverse events	9 Participants	4 Participants
Number of Participants With Treatment-emergent Adverse Events Treatment-related TEAEs leading to discontinuation of study drug	5 Participants	3 Participants
Number of Participants With Treatment-emergent Adverse Events Treatment-related fatal adverse events	1 Participants	1 Participants

Adverse Events

Cinacalcet

Serious events: 61 serious events

Other events: 293 other events

Deaths: 9 deaths

Etelcalcetide

Serious events: 53 serious events

Other events: 294 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cinacalcet n=315 participants at risk Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.	Etelcalcetide n=318 participants at risk Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
Gastrointestinal disorders Abdominal discomfort	5.4% 17/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.7% 15/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	3.8% 12/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.7% 18/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	4.4% 14/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.0% 19/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	14.3% 45/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	11.0% 35/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	14.9% 47/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	9.4% 30/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chest discomfort	5.1% 16/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.7% 15/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	9.8% 31/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.8% 28/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	10.5% 33/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	10.7% 34/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood calcium decreased	69.2% 218/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	79.2% 252/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood calcium increased	5.1% 16/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.0% 16/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood pressure increased	5.7% 18/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.8% 12/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	5.7% 18/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.1% 10/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	5.4% 17/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.8% 12/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	4.1% 13/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.0% 19/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperphosphataemia	10.8% 34/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.2% 26/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	4.8% 15/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	11.0% 35/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	5.4% 17/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.2% 7/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	11.7% 37/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	15.1% 48/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	7.6% 24/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	8.8% 28/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	2.5% 8/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.9% 22/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	9.2% 29/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	7.2% 23/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	4.1% 13/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.0% 16/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Dialysis hypotension	3.5% 11/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.7% 18/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertension	5.7% 18/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.0% 16/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypotension	8.6% 27/315 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	10.7% 34/318 • From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days). All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.