Secondary HyperparathyroidismPhase 3NCT03299244
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
A Phase 3 study testing Etelcalcetide and Cinacalcet in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by Amgen at 90 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- What is being tested?
- Etelcalcetide and Cinacalcet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 637 participants
- Where
- 90 sitesin 6 countries
- Study dates
- 15 May 2018to 8 Apr 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
90 sites in 6 countries.
90 sites in 6 countries
China43 sites
Research Site
Beijing, Beijing Municipality, 100034
Research Site
Changchun, Jilin, 130021
Research Site
Changchun, Jilin, 130041
Research Site
Changsha, Hunan, 410008
Research Site
Changsha, Hunan, 410011
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Changzhou, Jiangsu, 213003
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Chengdu, Sichuan, 610041
Research Site
Chengdu, Sichuan, 610072
Research Site
Dalian, Liaoning, 116001
Research Site
Dalian, Liaoning, 116011
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Dalian, Liaoning, 116027
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Guangzhou, Guangdong, 510080
Research Site
Guangzhou, Guangdong, 510120
Research Site
Guangzhou, Guangdong, 510150
Research Site
Guangzhou, Guangdong, 510180
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Guangzhou, Guangdong, 510630
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Hangzhou, Zhejiang, 310003
Research Site
Hangzhou, Zhejiang, 310009
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Lanzhou, Gansu, 730000
Research Site
Nanjing, Jiangsu, 210009
Research Site
Nanjing, Jiangsu, 210029
Research Site
Nanning, Guangxi, 530021
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Nanning, Guangxi, 530022
Research Site
Qingdao, Shandong, 266005
Research Site
Shanghai, Shanghai Municipality, 200072
Research Site
Shanghai, Shanghai Municipality, 200090
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Shanghai, Shanghai Municipality, 200127
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Shanghai, Shanghai Municipality, 200240
Research Site
Shenyang, Liaoning, 110004
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Shenyang, Liaoning, 110022
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Shenzhen, Guangdong, 518035
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Taiyuan, Shanxi, 030001
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Tianjin, Tianjin Municipality, 300052
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Tianjin, Tianjin Municipality, 300121
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Ürümqi, Xinjiang, 830054
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Wuhan, Hubei, 430030
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Wuhan, Hubei, 430034
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Wuhan, Hubei, 430060
Research Site
Wuxi, Jiangsu, 214023
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Xi'an, Shaanxi, 710004
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Zhanjiang, Guangdong, 524001
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Zhengzhou, Henan, 450003
Research Site
Zhengzhou, Henan, 450052
India15 sites
Research Site
Ahmedabad, Gujarat, 380 006
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Belagavi, Karnataka, 590010
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Chandigarh, Punjab, 160 012
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Chennai, Tamil Nadu, 600 006
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Dehradun, Uttarakhand, 248 001
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Kozhikode, Kerala, 673 004
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Kozhikode, Kerala, 673 008
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Lucknow, Uttar Pradesh, 226 014
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Mysuru, Karnataka, 570001
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Nadiād, Gujarat, 387 001
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New Delhi, National Capital Territory of Delhi, 110 017
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New Delhi, National Capital Territory of Delhi, 110 025
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New Delhi, National Capital Territory of Delhi, 110 060
Research Site
New Delhi, National Capital Territory of Delhi, 110 070
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Wardha, 442 004
Taiwan13 sites
Research Site
Changhua, 50006
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Kaohsiung City, 83301
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Keelung, 20401
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New Taipei City, 23561
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Taichung, 40201
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Taichung, 40705
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Tainan, 70403
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Tainan, 71004
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Taipei, 10002
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Taipei, 10449
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Taipei, 11031
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Taipei, 11101
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Taoyuan, 33305
South Korea12 sites
Research Site
Busan, 602-715
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Busan, 602-739
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Daegu, 700-721
Research Site
Gumi-si, Gyeongsangbuk-do, 730-728
Research Site
Guri-si, Gyeonggi-do, 471-701
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Seoul, 130-872
Research Site
Seoul, 133-817
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Seoul, 134-727
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Seoul, 135-720
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Seoul, 150-950
Research Site
Seoul, 156-707
Research Site
Seoul, 156-755
Malaysia4 sites
Research Site
Batu Caves, Selangor (incl. Putrajaya), 68100
Research Site
George Town, Pulau Pinang, 10990
Research Site
Ipoh, Perak, 30450
Research Site
Kuching, Sarawak, 93586
Hong Kong3 sites
Research Site
Hong Kong
Research Site
Kowloon
Research Site
New Territories
About this study
Official title: A Multicenter, Multiple-dose, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet Hydrochloride With Intravenous Doses of Etelcalcetide (AMG 416) in Asian Hemodialysis Subjects With Secondary Hyperparathyroidism
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.
- Being tested
- Etelcalcetide, Cinacalcet
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtelcalcetideDrug
Also called AMG 416, Parsabiv®
Administered intravenously three times per week.
CinacalcetDrug
Also called Sensipar®, Mimpara®
Cinacalcet administered orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| Cinacalcet | Active comparator | 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. Receives: Drug: Cinacalcet |
| Etelcalcetide | Experimental | 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. Receives: Drug: Etelcalcetide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and the efficacy assessment phase (EAP; defined as weeks 20 to 27, inclusive).
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Efficacy assessment phase (weeks 20 - 27, inclusive)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start15 May 2018
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299244
- Sponsor's protocol ID
- 20150238
- Status last verified
- Apr 2021
- First submitted
- 15 Sep 2017
- Last updated
- 30 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multiple-dose, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet Hydrochloride With Intravenous Doses of Etelcalcetide (AMG 416) in Asian Hemodialysis Subjects With Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT03299244
- Acronym / sponsor ID
- 20150238
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 15 May 2018 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Posted 30 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinacalcet | Active comparator | Drug: CinacalcetParticipants 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. |
| Etelcalcetide | Experimental | Drug: EtelcalcetideParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtelcalcetideAlso: AMG 416, Parsabiv®Administered intravenously three times per week. | Drug | Etelcalcetide |
| CinacalcetAlso: Sensipar®, Mimpara®Cinacalcet administered orally once a day. | Drug | Cinacalcet |
Primary outcome
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
Time frame: 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.
4 secondary outcomes
Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase
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
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
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
Time frame: Efficacy assessment phase (weeks 20 - 27, inclusive)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients
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Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
90 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etelcalcetide and Cinacalcet in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by Amgen at 90 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in China, India, Taiwan, South Korea, Malaysia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis (time frame: Baseline and the efficacy assessment phase (EAP; defined as weeks 20 to 27, inclusive).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.