Secondary HyperparathyroidismPhase 1NCT03283098
A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
A Phase 1 study testing Etelcalcetide in people with Secondary Hyperparathyroidism, run by Amgen at 5 sites in China.
Trial summary
This was a multiple-dose, double-blind, randomized, placebo-controlled study. Chinese subjects residing in Mainland China with chronic kidney disease (CKD) receiving hemodialysis were randomized in a 3:1 ratio to receive 5 mg intravenous (IV) of etelcalcetide or placebo 3 times a week (TIW) for approximately 4 weeks… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- Etelcalcetide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 5 sitesChina
- Study dates
- 1 Mar 2018to 4 Feb 2019
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- Resident in Mainland China and of Chinese ancestry
- Male or female subject ≥ 18 and ≤ 70 years of age at the time of screening, with end stage renal disease receiving hemodialysis
- Subject must be receiving hemodialysis 3 times weekly for at least 3 months through a functioning permanent dialysis access prior to Day -2 and have adequate hemodialysis with a delivered Kt/V ≥ 1.2 or urea reduction ratio (URR) ≥ 65% within 4 weeks to screening. The subject's routine hemodialysis session must be of 3-4.5 hours in duration, inclusive
- Subject has stable dialysis prescription and this prescription is not anticipated to significantly change during the course of the study
Who cannot join
- Corrected calcium (calculated) level is < 2.07 mmol/L (8.3 mg/dL), and/or intact PTH level is outside the range of 31.8 - 127.3 pmol/L (300 - 1200 pg/mL)
- Female subjects who are pregnant, lactating/breastfeeding, or who plan to conceive, or breastfeed while on study through 3 months after receiving the dose of study drug
- Female subject of reproductive potential not willing to use a(n) acceptable method(s) of effective birth control during treatment with AMG 416, and for an additional 3 months after the end of treatment with AMG 416. Female subjects who have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal ligation, or who are postmenopausal are not required to use contraception. Postmenopausal is defined as:
- Age > 55 years with cessation of menses for 12 months or more
- Age < 55 but no spontaneous menses for at least 2 years
- Age < 55 years and spontaneous menses within the past 1 years, but currently amenorrheic, AND with postmenopausal gonadrotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (<5.3 pmol/L or 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved
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- Underwent a bilateral oophorectomy
- Females of reproductive potential with a positive pregnancy test, unless medical follow-up confirms the subject is not pregnant
- Previous administration of AMG 416
- Subject has received cinacalcet within the 30 days prior to informed consent (treatment with cinacalcet is prohibited during the study)
- Subject has lost 500 mL or more of blood or plasma within 8 weeks of study drug administration or during the study period
- Anticipated or scheduled to have major surgical procedures during the study period such as kidney transplant or parathyroidectomy
- History of malignancy within 5 years before Day -2 (except non melanoma skin cancers, or cervical carcinoma in situ)
- Subject's 12-lead electrocardiogram (ECG) at screening suggests unstable arrhythmia or other cardiac abnormality that could place the subject at increased risk, based upon the Investigator's opinion
- Subject has current or history of cardiovascular conditions such as uncontrolled hypertension, symptomatic ventricular dysrhythmias, Torsades de Pointes, angina pectoris congestive heart failure (New York Heart Association Classification III or IV), myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Research Site
Beijing, Beijing Municipality, 100044
Research Site
Nanjing, Jiangsu, 210029
Research Site
Shanghai, Shanghai Municipality, 200032
Research Site
Shanghai, Shanghai Municipality, 200040
Research Site
Shanghai, Shanghai Municipality, 200127
About this study
Official title: A Phase 1, Multiple Dose, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pharmacokinetics, Safety and Tolerability of AMG 416 Administered Intravenously to Chinese Subjects With Chronic Kidney Disease on Hemodialysis
This was a multiple-dose, double-blind, randomized, placebo-controlled study. Chinese subjects residing in Mainland China with chronic kidney disease (CKD) receiving hemodialysis were randomized in a 3:1 ratio to receive 5 mg intravenous (IV) of etelcalcetide or placebo 3 times a week (TIW) for approximately 4 weeks, with a subsequent follow up period of approximately 4 weeks.
Doses were given at the end of each scheduled hemodialysis session on study days 1 through day 27 and subject participation was complete after day 55 end-of-study (EOS) procedures were performed. Doses were administered TIW for 4 weeks, for a total of 12 doses.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- Etelcalcetide, Placebo
- Keywords
- Secondary hyperparathyroidism, Chronic kidney disease CKD, Intact parathyroid hormone iPTH, Hemodialysis
- 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
Etelcalcetide was supplied as a sterile, preservative-free, aqueous solution in a single-use 3 mL glass vial.
PlaceboDrug
Placebo supplied to match active intervention.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intravenous (IV) administration of placebo three times a week (TIW) for 4 weeks for a total of 12 doses. Participants were followed for an additional 4 weeks. Receives: Drug: Placebo |
| Etelcalcetide | Experimental | 5 mg intravenous (IV) dose of etelcalcetide three times a week (TIW) for 4 weeks for a total of 12 doses. Participants were followed for an additional 4 weeks. Receives: Drug: Etelcalcetide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) Parameter: Time to Maximum Drug Concentration (Tmax) of Plasma Etelcalcetide on Days 1 and 27
Tmax is the time to maximum drug concentration of plasma etelcalcetide after dosing on Days 1 and 27.
Measured: Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration
PK: Maximum Observed Drug Concentration (Cmax) of Plasma Etelcalcetide on Days 1 and 27
Cmax was defined as the maximum observed plasma drug concentration measured between the time of drug administration to the beginning of the next dialysis session.
Measured: Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration
Pharmacokinetic (PK) Parameter: Area Under the Curve From Time Zero to the Beginning of the Subsequent Hemodialysis Treatment (AUClast) of Plasma Etelcalcetide on Days 1 and 27
AUClast was specifically defined in this study as the area under the concentration time curve measured from the time of drug administration to the beginning of the next dialysis session, following the first and last dose.
Measured: Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29
Pharmacokinetic (PK) Parameter: Accumulation Ratio Comparing Days 1 and 27
Accumulation ratio, calculated as AUClast day 27/AUClast day 1.
Measured: Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29
Secondary outcomes (12)
Participants With Treatment-Emergent Adverse Events (TEAEs)
The severity of each adverse event was assessed using the NCI-CTCAE Version 4.0 according to the following:
- Grade 1 - Mild: Asymptomatic or mild symptoms; intervention not indicated
- Grade 2 - Moderate: Minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL)
- Grade 3 - Severe: Medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL
- Grade 4 - Life-threatening
- Grade 5 - Fatal.
A serious AE is an AE that met one or more of the following criteria:
- Death
- Life-threatening
- Required inpatient hospitalization or prolongation of an existing hospitalization
- Resulted in persistent or significant disability/incapacity
- A congenital anomaly/birth defect
- Important medical events that required medical or surgical intervention to prevent one of the outcomes above.
Measured: Day 1 up to Day 55 (end of study)
Participants With Treatment-Emergent Adverse Events (TEAEs) of Interest
Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. Narrow search criteria used for both standardized MedDRA queries (SMQ) and events of interest (EOI). One preferred term (PT) could match multiple EOIs. Infusion Reaction EOI counts included only those events which had onset day coinciding with study medication infusion and resolved on the same day or the day after onset.
Measured: Day 1 up to Day 55 (end of study)
Participants With Clinically-Significant Changes in Electrocardiograms (ECGs) From Baseline to End of Study
Count of participants who exhibited a clinically significant change in the results of their 12-lead electrocardiograms (ECG) when comparing baseline to end of study ECGs.
Measured: Baseline is Day -2; End of Study is Day 55
Change From Baseline to End of Study in Weight
Change from baseline in weight measured at visit.
Measured: Day 1 up to Day 55
Change From Baseline to End of Study in Systolic and Diastolic Blood Pressures
Participants remained seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure.
Measured: Baseline Day 1 prior to dialysis; End of Study is Day 55
Baseline and Change From Baseline to End of Study in Heart Rate
Participants remained seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure.
Measured: Baseline Day 1 prior to dialysis; End of Study is Day 55
Change From Baseline to End of Study in Calcium
Calcium was tested at a central laboratory.
Measured: Baseline is Day 1 prior to dialysis; End of Study is Day 55
Change From Baseline to End of Study in Corrected Calcium (cCa)
Total serum calcium was corrected if the serum albumin was < 4 g/dL or 40 g/L, otherwise cCa equals total serum calcium.
The correction formula was:
Corrected calcium (mg/dL) = Total calcium (mg/dL) + (4 - albumin [g/dL]) * 0.8
Measured: Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55
Participants With Low Corrected Calcium (cCA) By Category
The lowest cCA value for each participant is reported.
Total serum calcium was corrected if the serum albumin was < 4 g/dL or 40 g/L, otherwise cCa equals total serum calcium.
The correction formula was:
Corrected calcium (mg/dL) = Total calcium (mg/dL) + (4 - albumin [g/dL]) * 0.8
Measured: Timeframes: Days 8, 15, 22, 27, 29, 34, 41, 55
Baseline and Change From Baseline to End of Study in Serum Albumin
Serum albumin was tested at a central laboratory.
Measured: Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55
Change From Baseline to End of Study in Serum Phosphorus
Serum phosphorus was tested at a central laboratory.
Measured: Baseline is Day 1 prior to dialysis; End of Study is Day 55
Participants With Anti-etelcalcetide Antibody at Baseline and Postbaseline
Participants with positive titers for antibodies to etelcalcetide could be asked to return to the clinical research unit to provide additional serum samples.
Measured: Baseline: Day 1 prior to dialysis. Postbaseline: Days 29 and 55 prior to dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Mar 2018
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multiple dose, double-blind, randomized, placebo-controlled clinical study conducted in Chinese subjects residing in Mainland China with chronic kidney disease receiving hemodialysis. The treatment duration will be approximately 4 weeks with a post treatment followup of 4 weeks. A dose will be given at each scheduled hemodialysis session (Dose administered three times a week for 4 weeks, for a total of 12 doses).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 33 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
- NCT03283098
- Sponsor's protocol ID
- 20140197
- Status last verified
- Jan 2020
- First submitted
- 31 Aug 2017
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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.
Publications
Xing C, Chen J, Zuo L, Fang Y, Ding X, Ni Z, Kong C, Shi G, Lu H, Hellawell J, Cheng S, Sohn W. A Phase I, Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Etelcalcetide Administered Intravenously to Chinese Patients With Chronic Kidney Disease Undergoing Hemodialysis. Clin Ther. 2021 Nov;43(11):2013-2023. doi: 10.1016/j.clinthera.2021.09.019. Epub 2021 Nov 11.
PubMed 34774334
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multiple Dose, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pharmacokinetics, Safety and Tolerability of AMG 416 Administered Intravenously to Chinese Subjects With Chronic Kidney Disease on Hemodialysis
- ClinicalTrials.gov ID
- NCT03283098
- Acronym / sponsor ID
- 20140197
- Conditions
- Secondary Hyperparathyroidism
- Keywords
- Secondary hyperparathyroidism, Chronic kidney disease CKD, Intact parathyroid hormone iPTH, Hemodialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Posted 10 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multiple-dose, double-blind, randomized, placebo-controlled study. Chinese subjects residing in Mainland China with chronic kidney disease (CKD) receiving hemodialysis were randomized in a 3:1 ratio to receive 5 mg intravenous (IV) of etelcalcetide or placebo 3 times a week (TIW) for approximately 4 weeks, with a subsequent follow up period of approximately 4 weeks.
Doses were given at the end of each scheduled hemodialysis session on study days 1 through day 27 and subject participation was complete after day 55 end-of-study (EOS) procedures were performed. Doses were administered TIW for 4 weeks, for a total of 12 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a multiple dose, double-blind, randomized, placebo-controlled clinical study conducted in Chinese subjects residing in Mainland China with chronic kidney disease receiving hemodialysis. The treatment duration will be approximately 4 weeks with a post treatment followup of 4 weeks. A dose will be given at each scheduled hemodialysis session (Dose administered three times a week for 4 weeks, for a total of 12 doses).
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIntravenous (IV) administration of placebo three times a week (TIW) for 4 weeks for a total of 12 doses. Participants were followed for an additional 4 weeks. |
| Etelcalcetide | Experimental | Drug: Etelcalcetide5 mg intravenous (IV) dose of etelcalcetide three times a week (TIW) for 4 weeks for a total of 12 doses. Participants were followed for an additional 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- Resident in Mainland China and of Chinese ancestry
- Male or female subject ≥ 18 and ≤ 70 years of age at the time of screening, with end stage renal disease receiving hemodialysis
- Subject must be receiving hemodialysis 3 times weekly for at least 3 months through a functioning permanent dialysis access prior to Day -2 and have adequate hemodialysis with a delivered Kt/V ≥ 1.2 or urea reduction ratio (URR) ≥ 65% within 4 weeks to screening. The subject's routine hemodialysis session must be of 3-4.5 hours in duration, inclusive
- Subject has stable dialysis prescription and this prescription is not anticipated to significantly change during the course of the study
Key exclusion criteria (15 listed)
- Corrected calcium (calculated) level is < 2.07 mmol/L (8.3 mg/dL), and/or intact PTH level is outside the range of 31.8 - 127.3 pmol/L (300 - 1200 pg/mL)
- Female subjects who are pregnant, lactating/breastfeeding, or who plan to conceive, or breastfeed while on study through 3 months after receiving the dose of study drug
- Female subject of reproductive potential not willing to use a(n) acceptable method(s) of effective birth control during treatment with AMG 416, and for an additional 3 months after the end of treatment with AMG 416. Female subjects who have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal ligation, or who are postmenopausal are not required to use contraception. Postmenopausal is defined as:
- Females of reproductive potential with a positive pregnancy test, unless medical follow-up confirms the subject is not pregnant
- Previous administration of AMG 416
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 416Etelcalcetide was supplied as a sterile, preservative-free, aqueous solution in a single-use 3 mL glass vial. | Drug | Etelcalcetide |
| PlaceboPlacebo supplied to match active intervention. | Drug | Placebo |
Primary outcome
Pharmacokinetic (PK) Parameter: Time to Maximum Drug Concentration (Tmax) of Plasma Etelcalcetide on Days 1 and 27
Time frame: Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration
Tmax is the time to maximum drug concentration of plasma etelcalcetide after dosing on Days 1 and 27.
PK: Maximum Observed Drug Concentration (Cmax) of Plasma Etelcalcetide on Days 1 and 27
Time frame: Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration
Cmax was defined as the maximum observed plasma drug concentration measured between the time of drug administration to the beginning of the next dialysis session.
Pharmacokinetic (PK) Parameter: Area Under the Curve From Time Zero to the Beginning of the Subsequent Hemodialysis Treatment (AUClast) of Plasma Etelcalcetide on Days 1 and 27
Time frame: Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29
AUClast was specifically defined in this study as the area under the concentration time curve measured from the time of drug administration to the beginning of the next dialysis session, following the first and last dose.
Pharmacokinetic (PK) Parameter: Accumulation Ratio Comparing Days 1 and 27
Time frame: Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29
Accumulation ratio, calculated as AUClast day 27/AUClast day 1.
12 secondary outcomes
Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 55 (end of study)
Participants With Treatment-Emergent Adverse Events (TEAEs) of Interest
Time frame: Day 1 up to Day 55 (end of study)
Participants With Clinically-Significant Changes in Electrocardiograms (ECGs) From Baseline to End of Study
Time frame: Baseline is Day -2; End of Study is Day 55
Change From Baseline to End of Study in Weight
Time frame: Day 1 up to Day 55
Change From Baseline to End of Study in Systolic and Diastolic Blood Pressures
Time frame: Baseline Day 1 prior to dialysis; End of Study is Day 55
Baseline and Change From Baseline to End of Study in Heart Rate
Time frame: Baseline Day 1 prior to dialysis; End of Study is Day 55
Change From Baseline to End of Study in Calcium
Time frame: Baseline is Day 1 prior to dialysis; End of Study is Day 55
Change From Baseline to End of Study in Corrected Calcium (cCa)
Time frame: Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55
Participants With Low Corrected Calcium (cCA) By Category
Time frame: Timeframes: Days 8, 15, 22, 27, 29, 34, 41, 55
Baseline and Change From Baseline to End of Study in Serum Albumin
Time frame: Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55
Change From Baseline to End of Study in Serum Phosphorus
Time frame: Baseline is Day 1 prior to dialysis; End of Study is Day 55
Participants With Anti-etelcalcetide Antibody at Baseline and Postbaseline
Time frame: Baseline: Day 1 prior to dialysis. Postbaseline: Days 29 and 55 prior to dialysis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34774334Xing C, Chen J, Zuo L, Fang Y, Ding X, Ni Z, Kong C, Shi G, Lu H, Hellawell J, Cheng S, Sohn W. A Phase I, Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Etelcalcetide Administered Intravenously to Chinese Patients With Chronic Kidney Disease Undergoing Hemodialysis. Clin Ther. 2021 Nov;43(11):2013-2023. doi: 10.1016/j.clinthera.2021.09.019. Epub 2021 Nov 11.
- 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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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etelcalcetide in people with Secondary Hyperparathyroidism, run by Amgen at 5 sites in China.
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 5 inclusion and 15 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 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 10 Feb 2020). 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?
Pharmacokinetic (PK) Parameter: Time to Maximum Drug Concentration (Tmax) of Plasma Etelcalcetide on Days 1 and 27 (time frame: Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03283098, which also lists 1 linked publication.
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 10 Feb 2020.