Chronic Kidney Disease, Secondary Hyperparathyroidism
Conditions
Brief summary
The primary objective is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by \> 30% from baseline among participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
Interventions
DRUGEtelcalcetide
Administered intravenously three times per week.
DRUGCinacalcet
Cinacalcet administered orally once a day.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will be randomized by Interactive Voice Response (IVR)/Interactive Web Response (IWR) in a 1:1 ratio to either three times per week (TIW) intravenous (IV) etelcalcetide (and daily oral placebo tablets) or daily oral cinacalcet tablets (and TIW IV placebo) in a double-blind, double-dummy manner. Treatment groups will be blinded to the investigator, participants, and the Amgen study team.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has provided informed consent prior to performing any study-related activities/procedures. * Male or female subjects ≥ 18 years of age or older at the time of signing informed consent. * Subject must be receiving maintenance hemodialysis 3 times weekly for at least 3 months, with adequate hemodialysis based on a delivered measure of dialysis adequacy (Kt/V) ≥ 1.2 or urea reduction ratio ≥ 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. * 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. * 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 or for safety reasons. * Subject must have 1 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 or for safety reasons.
Exclusion criteria
* Currently receiving treatment in another investigational device or drug study, or ≤ 30 days since ending treatment on another investigational device or drug study(s). Other investigational procedures while participating in this study are excluded. * Subject has received etelcalcetide in a prior clinical trial of etelcalcetide. * 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 etelcalcetide to be administered during dosing. * Subject has previously been randomized in 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 of screening (except non-melanoma skin cancers or cervical carcinoma in situ). * Grapefruit juice is prohibited. * 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 * 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. * 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 \< 3.0 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 \[SGOT\]) \> 3 times the upper limit of normal (ULN) at screening. * 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis | Baseline and the efficacy assessment phase (EAP; defined as weeks 20 to 27, inclusive). | Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive). | Predialysis intact parathyroid hormone levels were measured by a central laboratory. |
| Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis | Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive) | Predialysis intact parathyroid hormone levels were measured by a central laboratory. |
| Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (weeks 20 - 27, inclusive) | Predialysis corrected calcium was measured by a central laboratory. |
| Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase | Efficacy assessment phase (weeks 20 - 27, inclusive) | Predialysis serum phosphorus was measured by a central laboratory. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study | From first dose of study drug to end of study; up to 26 weeks + 30 days. | Corrected calcium was measured by the central laboratory. |
| Number of Participants With Treatment-emergent Adverse Events | From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days. | 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 |
| Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study | From first dose of study drug to end of study; up to 26 weeks + 30 days. | Corrected calcium was measured by the central laboratory. |
| Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study | From first dose of study drug to end of study; up to 26 weeks + 30 days. | Corrected calcium was measured by the central laboratory. |
| Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study | From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days. | 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. |
| Number of Participants Who Developed Antibodies to Etelcalcetide | From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days. | Developing antibody incidence is defined as participants who were binding antibody positive post-baseline with a negative or no result at baseline. |
Countries
China, Hong Kong, India, Malaysia, South Korea, Taiwan
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 317 |
| 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. | 320 |
| Total | 637 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 9 | 4 |
| Overall Study | Decision by Sponsor | 4 | 5 |
| Overall Study | Withdrawal by Subject | 34 | 29 |
Baseline characteristics
| Characteristic | Cinacalcet | Etelcalcetide | Total |
|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 12.9 | 52.2 years STANDARD_DEVIATION 13.4 | 51.8 years STANDARD_DEVIATION 13.1 |
| Age, Customized 18 - 64 years | 264 Participants | 262 Participants | 526 Participants |
| Age, Customized 65 - 74 years | 45 Participants | 47 Participants | 92 Participants |
| Age, Customized 75 - 84 years | 8 Participants | 9 Participants | 17 Participants |
| Age, Customized ≥ 85 years | 0 Participants | 2 Participants | 2 Participants |
| Corrected Calcium Level | 9.71 mg/dL STANDARD_DEVIATION 0.75 | 9.73 mg/dL STANDARD_DEVIATION 0.9 | 9.72 mg/dL STANDARD_DEVIATION 0.83 |
| Corrected Calcium Phosphorus Product (cCa x P) | 64.70 mg²/dL² STANDARD_DEVIATION 16.39 | 64.41 mg²/dL² STANDARD_DEVIATION 16.33 | 64.56 mg²/dL² STANDARD_DEVIATION 16.35 |
| Intact Parathyroid Hormone Level | 1299.01 pg/mL STANDARD_DEVIATION 830.99 | 1299.91 pg/mL STANDARD_DEVIATION 853.82 | 1299.46 pg/mL STANDARD_DEVIATION 841.87 |
| Phosphorus Level | 6.67 mg/dL STANDARD_DEVIATION 1.61 | 6.62 mg/dL STANDARD_DEVIATION 1.55 | 6.64 mg/dL STANDARD_DEVIATION 1.58 |
| Race/Ethnicity, Customized Asian Indian | 19 Participants | 19 Participants | 38 Participants |
| Race/Ethnicity, Customized Chinese | 262 Participants | 270 Participants | 532 Participants |
| Race/Ethnicity, Customized Other | 36 Participants | 31 Participants | 67 Participants |
| Sex: Female, Male Female | 138 Participants | 142 Participants | 280 Participants |
| Sex: Female, Male Male | 179 Participants | 178 Participants | 357 Participants |
| Stratification Factor: Country/Region China | 189 Participants | 191 Participants | 380 Participants |
| Stratification Factor: Country/Region Non-China | 128 Participants | 129 Participants | 257 Participants |
| Stratification Factor: Screening Corrected Calcium (cCa) < 9 mg/dL | 62 Participants | 64 Participants | 126 Participants |
| Stratification Factor: Screening Corrected Calcium (cCa) ≥ 9 mg/dL | 255 Participants | 256 Participants | 511 Participants |
| Stratification Factor: Screening Intact Parathyroid Hormone (iPTH) < 900 pg/mL | 128 Participants | 131 Participants | 259 Participants |
| Stratification Factor: Screening Intact Parathyroid Hormone (iPTH) ≥ 900 pg/mL | 189 Participants | 189 Participants | 378 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 317 | 4 / 320 |
| other Total, other adverse events | 293 / 315 | 294 / 318 |
| serious Total, serious adverse events | 61 / 315 | 53 / 318 |
Outcome results
Primary
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | 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 |
| Etelcalcetide | Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis | 71.9 percentage of participants |
Comparison: The analysis was conducted on the full analysis set (637 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment (Cinacalcet - Etelcalcetide), stratified by screening PTH level (\< 900 pg/mL, ≥ 900 pg/mL), screening serum cCa (\< 9.0 mg/dL, ≥ 9.0 mg/dL) measured by the central laboratory, and country (China versus non-China).95% CI: [-3.05, 12.09]
Secondary
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis
Predialysis intact parathyroid hormone levels were measured by a central laboratory.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis | 58.0 percentage of participants |
| Etelcalcetide | Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis | 66.3 percentage of participants |
p-value: 0.03395% CI: [1.03, 1.96]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase
Predialysis intact parathyroid hormone levels were measured by a central laboratory.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase | 41.6 percentage of participants |
| Etelcalcetide | Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase | 59.1 percentage of participants |
p-value: <0.00195% CI: [1.47, 2.77]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase
Predialysis serum phosphorus was measured by a central laboratory.
Time frame: Efficacy assessment phase (weeks 20 - 27, inclusive)
Population: Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cinacalcet | Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase | 26.2 percentage of participants |
| Etelcalcetide | Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase | 29.1 percentage of participants |
p-value: 0.4195% CI: [0.82, 1.65]Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase
Predialysis corrected calcium was measured by a central laboratory.
Time frame: Baseline and the efficacy assessment phase (weeks 20 - 27, inclusive)
Population: Full analysis set; participants with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cinacalcet | Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase | -8.00 percent change | Standard Error 0.5 |
| Etelcalcetide | Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase | -10.69 percent change | Standard Error 0.53 |
p-value: <0.00195% CI: [-4.14, -1.5]Mixed-effects Model Repeated Measures
Other Pre-specified
Number of Participants Who Developed Antibodies to Etelcalcetide
Developing antibody incidence is defined as participants who were binding antibody positive post-baseline with a negative or no result at baseline.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cinacalcet | Number of Participants Who Developed Antibodies to Etelcalcetide | 18 Participants |
Other Pre-specified
Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study
Corrected calcium was measured by the central laboratory.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cinacalcet | Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study | 61 Participants |
| Etelcalcetide | Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study | 109 Participants |
Other Pre-specified
Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study
Corrected calcium was measured by the central laboratory.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cinacalcet | Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study | 194 Participants |
| Etelcalcetide | Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study | 241 Participants |
Other Pre-specified
Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study
Corrected calcium was measured by the central laboratory.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cinacalcet | Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study | 245 Participants |
| Etelcalcetide | Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study | 273 Participants |
Other Pre-specified
Number of Participants With Treatment-emergent Adverse Events
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
Time frame: From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.
Population: Safety analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cinacalcet | Number of Participants With Treatment-emergent Adverse Events | Any treatment-emergent adverse event (TEAE) | 303 Participants |
| Cinacalcet | Number of Participants With Treatment-emergent Adverse Events | Serious adverse events | 61 Participants |
| Cinacalcet | Number of Participants With Treatment-emergent Adverse Events | TEAEs leading to discontinuation of study drug | 15 Participants |
| Cinacalcet | Number of Participants With Treatment-emergent Adverse Events | Fatal adverse events | 9 Participants |
| Cinacalcet | Number of Participants With Treatment-emergent Adverse Events | Treatment-related TEAEs | 243 Participants |
| Cinacalcet | Number of Participants With Treatment-emergent Adverse Events | Treatment-related serious adverse events | 4 Participants |
| Cinacalcet | Number of Participants With Treatment-emergent Adverse Events | Treatment-related TEAEs leading to discontinuation of study drug | 5 Participants |
| Cinacalcet | Number of Participants With Treatment-emergent Adverse Events | Treatment-related fatal adverse events | 1 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Treatment-related fatal adverse events | 1 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Any treatment-emergent adverse event (TEAE) | 306 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Treatment-related TEAEs | 250 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Serious adverse events | 53 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Treatment-related TEAEs leading to discontinuation of study drug | 3 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | TEAEs leading to discontinuation of study drug | 9 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Treatment-related serious adverse events | 4 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Adverse Events | Fatal adverse events | 4 Participants |
Other Pre-specified
Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study
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.
Time frame: From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.
Population: Safety analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cinacalcet | Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study | 15 Participants |
| Etelcalcetide | Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study | 35 Participants |