CompletedNCT03299244Updated Apr 30, 2021Results posted

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

A Phase 3 interventional study of Etelcalcetide and Cinacalcet in Secondary Hyperparathyroidism and Chronic Kidney Disease, sponsored by Amgen. Completed at 90 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-30.

Sponsored by Amgen · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 637
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Secondary Hyperparathyroidism
Chronic Kidney Disease

Browse trials for

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 637 participants (actual)

Study arms

Active comparator
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 the dose may have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum parathyroid hormone (PTH) ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
Drug: Cinacalcet
Experimental
Etelcalcetide
Participants were randomized to receive etelcalcetide administered by intravenous 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 the dose may 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.
Drug: Etelcalcetide

Interventions

DrugEtelcalcetide
Administered intravenously three times per week.
Also known as: AMG 416, Parsabiv®
DrugCinacalcet
Cinacalcet administered orally once a day.
Also known as: Sensipar®, Mimpara®

What researchers measure

Primary outcomes

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).

Secondary outcomes

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).
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)
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)
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)

Other outcomes

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.
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.
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.
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.
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.
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.

Results

Posted Apr 30, 2021

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.

Participant flow — Overall Study
Milestone	Cinacalcet	Etelcalcetide
Started	317	320
Received treatment	315	318
Completed	270	282
Not completed	47	38
Withdrew: Withdrawal by subject	34	29
Withdrew: Decision by sponsor	4	5
Withdrew: Death	9	4

Outcome measures

PrimaryPercentage 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).
Reported as:: Number · percentage of participants

Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
percentage of participants	Cinacalcet	Etelcalcetide
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis	66.2	71.9

Statistical analysis

Cinacalcet vs Etelcalcetide · Treatment difference: 4.52 · 95% CI -3.05 to 12.09Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.

SecondaryPercentage 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).
Reported as:: Number · percentage of participants

Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase
percentage of participants	Cinacalcet	Etelcalcetide
Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase	41.6	59.1

Statistical analysis

Cinacalcet vs Etelcalcetide · Cochran-Mantel-Haenszel · p = <0.001 · Odds ratio (or): 2.02 · 95% CI 1.47 to 2.77Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.

SecondaryPercentage 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)
Reported as:: Number · percentage of participants

Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis
percentage of participants	Cinacalcet	Etelcalcetide
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis	58.0	66.3

Statistical analysis

Cinacalcet vs Etelcalcetide · Cochran-Mantel-Haenszel · p = 0.033 · Odds ratio (or): 1.42 · 95% CI 1.03 to 1.96Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.

SecondaryPercent 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)
Reported as:: Mean · percent change

Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase
percent change	Cinacalcet	Etelcalcetide
Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase	-8.00 ± 0.50	-10.69 ± 0.53

Statistical analysis

Cinacalcet vs Etelcalcetide · Mixed-effects Model Repeated Measures · p = <0.001 · Difference in least squares means: -2.82 · 95% CI -4.14 to -1.50Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region. Standard error of the mean is the standard error of the least squares means difference.

SecondaryPercentage 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)
Reported as:: Number · percentage of participants

Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase
percentage of participants	Cinacalcet	Etelcalcetide
Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase	26.2	29.1

Statistical analysis

Cinacalcet vs Etelcalcetide · Cochran-Mantel-Haenszel · p = 0.41 · Odds ratio (or): 1.16 · 95% CI 0.82 to 1.65Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.

Other pre-specifiedNumber 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.
Reported as:: Count of participants · Participants

Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study
Participants	Cinacalcet	Etelcalcetide
Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study	245	273

Other pre-specifiedNumber 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.
Reported as:: Count of participants · Participants

Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study
Participants	Cinacalcet	Etelcalcetide
Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study	194	241

Other pre-specifiedNumber 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.
Reported as:: Count of participants · Participants

Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study
Participants	Cinacalcet	Etelcalcetide
Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study	61	109

Other pre-specifiedNumber 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.
Reported as:: Count of participants · Participants

Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study
Participants	Cinacalcet	Etelcalcetide
Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study	15	35

Other pre-specifiedNumber 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.
Reported as:: Count of participants · Participants

Number of Participants Who Developed Antibodies to Etelcalcetide
Participants	Etelcalcetide
Number of Participants Who Developed Antibodies to Etelcalcetide	18

Other pre-specifiedNumber 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.
Reported as:: Count of participants · Participants

Number of Participants With Treatment-emergent Adverse Events
Participants	Cinacalcet	Etelcalcetide
Any treatment-emergent adverse event (TEAE)	303	306
Serious adverse events	61	53
TEAEs leading to discontinuation of study drug	15	9
Fatal adverse events	9	4
Treatment-related TEAEs	243	250
Treatment-related serious adverse events	4	4
Treatment-related TEAEs leading to discontinuation of study drug	5	3
Treatment-related fatal adverse events	1	1

Adverse events

Collected over From first dose of study drug to 30 days after last dose (up to 26 weeks + 30 days).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cinacalcet	9/317 (2.8%)	61/315 (19.4%)	293/315 (93%)
Etelcalcetide	4/320 (1.3%)	53/318 (16.7%)	294/318 (92.5%)

Most frequent serious events

Showing 10 of 106

Most frequent serious events
Event	Cinacalcet	Etelcalcetide
PneumoniaInfections and infestations	4/315	7/318
Arteriovenous fistula occlusionInjury, poisoning and procedural complications	3/315	5/318
HypertensionVascular disorders	1/315	4/318
Acute myocardial infarctionCardiac disorders	3/315	0/318
End stage renal diseaseRenal and urinary disorders	2/315	3/318
Arteriosclerosis coronary arteryCardiac disorders	2/315	0/318
Cardiac failure acuteCardiac disorders	2/315	2/318
Coronary artery diseaseCardiac disorders	2/315	0/318
CataractEye disorders	2/315	0/318
PeritonitisInfections and infestations	2/315	1/318

Most frequent other events

Showing 10 of 25

Most frequent other events
Event	Cinacalcet	Etelcalcetide
Blood calcium decreasedInvestigations	218/315	252/318
Muscle spasmsMusculoskeletal and connective tissue disorders	37/315	48/318
VomitingGastrointestinal disorders	47/315	30/318
NauseaGastrointestinal disorders	45/315	35/318
HypocalcaemiaMetabolism and nutrition disorders	15/315	35/318
HyperphosphataemiaMetabolism and nutrition disorders	34/315	26/318
Upper respiratory tract infectionInfections and infestations	33/315	34/318
HypotensionVascular disorders	27/315	34/318
NasopharyngitisInfections and infestations	31/315	28/318
CoughRespiratory, thoracic and mediastinal disorders	29/315	23/318

Baseline characteristics

The full analysis set includes all randomized participants.

Age, Continuous
Age, Continuous(years)	Cinacalcet	Etelcalcetide	Total
Mean	51.5 ± 12.9	52.2 ± 13.4	51.8 ± 13.1

Age, Customized
Age, Customized(Participants)	Cinacalcet	Etelcalcetide	Total
18 - 64 years	264	262	526
65 - 74 years	45	47	92
75 - 84 years	8	9	17
≥ 85 years	0	2	2

Sex: Female, Male
Sex: Female, Male(Participants)	Cinacalcet	Etelcalcetide	Total
Female	138	142	280
Male	179	178	357

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Cinacalcet	Etelcalcetide	Total
Asian Indian	19	19	38
Chinese	262	270	532
Other	36	31	67

Stratification Factor: Screening Intact Parathyroid Hormone (iPTH)
Stratification Factor: Screening Intact Parathyroid Hormone (iPTH)(Participants)	Cinacalcet	Etelcalcetide	Total
< 900 pg/mL	128	131	259
≥ 900 pg/mL	189	189	378

Stratification Factor: Screening Corrected Calcium (cCa)
Stratification Factor: Screening Corrected Calcium (cCa)(Participants)	Cinacalcet	Etelcalcetide	Total
< 9 mg/dL	62	64	126
≥ 9 mg/dL	255	256	511

Stratification Factor: Country/Region
Stratification Factor: Country/Region(Participants)	Cinacalcet	Etelcalcetide	Total
China	189	191	380
Non-China	128	129	257

Intact Parathyroid Hormone Level
Intact Parathyroid Hormone Level(pg/mL)	Cinacalcet	Etelcalcetide	Total
Mean	1299.01 ± 830.99	1299.91 ± 853.82	1299.46 ± 841.87

3 further baseline measures are reported on the registry.

Study locations

90 sites

Research Site
Beijing, Beijing 100034, China
Research Site
Lanzhou, Gansu 730000, China
Research Site
Guangzhou, Guangdong 510080, China
Research Site
Guangzhou, Guangdong 510120, China
Research Site
Guangzhou, Guangdong 510150, China
Research Site
Guangzhou, Guangdong 510180, China
Research Site
Guangzhou, Guangdong 510630, China
Research Site
Shenzhen, Guangdong 518035, China
Research Site
Zhanjiang, Guangdong 524001, China
Research Site
Nanning, Guangxi 530021, China
Research Site
Nanning, Guangxi 530022, China
Research Site
Zhengzhou, Henan 450003, China
Research Site
Zhengzhou, Henan 450052, China
Research Site
Wuhan, Hubei 430030, China
Research Site
Wuhan, Hubei 430034, China
Research Site
Wuhan, Hubei 430060, China
Research Site
Changsha, Hunan 410008, China
Research Site
Changsha, Hunan 410011, China
Research Site
Changzhou, Jiangsu 213003, China
Research Site
Nanjing, Jiangsu 210009, China
Research Site
Nanjing, Jiangsu 210029, China
Research Site
Wuxi, Jiangsu 214023, China
Research Site
Changchun, Jilin 130021, China
Research Site
Changchun, Jilin 130041, China
Research Site
Dalian, Liaoning 116001, China
Research Site
Dalian, Liaoning 116011, China
Research Site
Dalian, Liaoning 116027, China
Research Site
Shenyang, Liaoning 110004, China
Research Site
Shenyang, Liaoning 110022, China
Research Site
Xian, Shaanxi 710004, China
Research Site
Qingdao, Shandong 266005, China
Research Site
Shanghai, Shanghai 200072, China
Research Site
Shanghai, Shanghai 200090, China
Research Site
Shanghai, Shanghai 200127, China
Research Site
Shanghai, Shanghai 200240, China
Research Site
Taiyuan, Shanxi 030001, China
Research Site
Chengdu, Sichuan 610041, China
Research Site
Chengdu, Sichuan 610072, China
Research Site
Tianjin, Tianjin 300052, China
Research Site
Tianjin, Tianjin 300121, China
Research Site
Urumqi, Xinjiang 830054, China
Research Site
Hangzhou, Zhejiang 310003, China
Research Site
Hangzhou, Zhejiang 310009, China
Research Site
Hong Kong, Hong Kong
Research Site
Kowloon, Hong Kong
Research Site
New Territories, Hong Kong
Research Site
New Delhi, Delhi 110 017, India
Research Site
New Delhi, Delhi 110 025, India
Research Site
New Delhi, Delhi 110 060, India
Research Site
New Delhi, Delhi 110 070, India
Research Site
Ahmedabad, Gujarat 380 006, India
Research Site
Nadiad, Gujarat 387 001, India
Research Site
Belagavi, Karnataka 590010, India
Research Site
Mysuru, Karnataka 570001, India
Research Site
Kozhikode, Kerala 673 004, India
Research Site
Kozhikode, Kerala 673 008, India
Research Site
Chandigarh, Punjab 160 012, India
Research Site
Chennai, Tamil Nadu 600 006, India
Research Site
Lucknow, Uttar Pradesh 226 014, India
Research Site
Dehradun, Uttaranchal 248 001, India
Research Site
Wardha, 442 004, India
Research Site
Busan, 602-715, Korea, Republic of
Research Site
Busan, 602-739, Korea, Republic of
Research Site
Daegu, 700-721, Korea, Republic of
Research Site
Gumi-si, Gyeongsangbuk-do, 730-728, Korea, Republic of
Research Site
Guri-si, Gyeonggi-do, 471-701, Korea, Republic of
Research Site
Seoul, 130-872, Korea, Republic of
Research Site
Seoul, 133-817, Korea, Republic of
Research Site
Seoul, 134-727, Korea, Republic of
Research Site
Seoul, 135-720, Korea, Republic of
Research Site
Seoul, 150-950, Korea, Republic of
Research Site
Seoul, 156-707, Korea, Republic of
Research Site
Seoul, 156-755, Korea, Republic of
Research Site
Ipoh, Perak 30450, Malaysia
Research Site
George Town, Pinang 10990, Malaysia
Research Site
Kuching, Sarawak 93586, Malaysia
Research Site
Batu Caves, Selangor (incl. Putrajaya) 68100, Malaysia
Research Site
Changhua, 50006, Taiwan
Research Site
Kaohsiung, 83301, Taiwan
Research Site
Keelung, 20401, Taiwan
Research Site
New Taipei, 23561, Taiwan
Research Site
Taichung, 40201, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Tainan, 70403, Taiwan
Research Site
Tainan, 71004, Taiwan
Research Site
Taipei, 10002, Taiwan
Research Site
Taipei, 10449, Taiwan
Research Site
Taipei, 11031, Taiwan
Research Site
Taipei, 11101, Taiwan
Research Site
Taoyuan, 33305, Taiwan

References and documents

Study documents

Study protocol · Nov 27, 2018
Statistical analysis plan · Apr 14, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting information: Study protocol, Sap, Icf, Csr

Registry details

Key details

Study ID: NCT03299244
Lead sponsor: Amgen
Responsible party: Sponsor
First posted: Oct 3, 2017
Start date: May 15, 2018
Primary completion: Apr 8, 2020
Completion: Apr 8, 2020
Results posted: Apr 30, 2021
Last update: Apr 30, 2021

Study contacts

study director · Amgen

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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

Study summary

Conditions studied

Browse trials for

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Other outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Related links

Study documents

Individual participant data

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria