Hyperparathyroidism, SecondaryPhase 3NCT01785849
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
A Phase 3 study testing Etelcalcetide in people with Hyperparathyroidism, Secondary, run by Amgen at 118 sites in 15 countries.
Trial summary
This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hyperparathyroidism, Secondary
- 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
- 508 participants
- Where
- 118 sitesin 15 countries
- Study dates
- 12 Mar 2013to 12 Jun 2014
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Subject is 18 years of age or older.
- Subject must be receiving hemodialysis 3 times weekly for at least 3 months
- Subject agrees to not participate in another study of an investigational agent during the study.
- Other Inclusion Criteria may apply
Who cannot join
- Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
- Other investigational procedures while participating in this study are excluded.
- Anticipated or scheduled parathyroidectomy during the study period.
- Subject has received a parathyroidectomy within 3 months prior to dosing.
- Anticipated or scheduled kidney transplant during the study period.
- Subject has known sensitivity to any of the products or components to be administered during dosing.
Show all 10Show fewer
- Subject has participated in a prior clinical trial of AMG 416 (also referred to as KAI-4169).
- Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study).
- 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.
- Other Exclusion Criteria may apply
Trial locations and contacts
118 sites in 15 countries.
118 sites in 15 countries
United States51 sites
Research Site
Allentown, Pennsylvania, 18104
Research Site
Amherst, New York, 14226
Research Site
Austin, Texas, 78758
Research Site
Azusa, California, 91702
Research Site
Birmingham, Alabama, 35211
Research Site
Bluefield, West Virginia, 24701
Research Site
Brooklyn, New York, 11235
Research Site
Chapel Hill, North Carolina, 27599
Research Site
Columbia, Tennessee, 38401
Research Site
Covina, California, 91723
Research Site
Detroit, Michigan, 48236
Research Site
Durham, North Carolina, 27704
Research Site
Evanston, Illinois, 60201
Research Site
Fairfax, Virginia, 22033
Research Site
Fort Worth, Texas, 76105
Research Site
Fort Worth, Texas, 76164
Research Site
Grand Prairie, Texas, 75050
Research Site
Houston, Texas, 77030
Research Site
Kalamazoo, Michigan, 49007
Research Site
Kansas City, Missouri, 64111
Research Site
Lakewood, California, 90712
Research Site
Los Angeles, California, 90025
Research Site
Lynwood, California, 90262
Research Site
Mansfield, Texas, 76063
Research Site
Mechanicsville, Virginia, 23116
Research Site
Meridian, Idaho, 83642
Research Site
Nashville, Tennessee, 37205
Research Site
Norfolk, Virginia, 23502
Research Site
Northridge, California, 91324
Research Site
Ontario, California, 91762
Research Site
Orangeburg, South Carolina, 29118
Research Site
Panorama City, California, 91402
Research Site
Pembroke Pines, Florida, 33028
Research Site
Philadelphia, Pennsylvania, 19106
Research Site
Philadelphia, Pennsylvania, 19118
Research Site
Pine Bluff, Arkansas, 71603
Research Site
Pontiac, Michigan, 48341
Research Site
Reno, Nevada, 89511
Research Site
Rosedale, New York, 11422
Research Site
Sacramento, California, 95825
Research Site
San Antonio, Texas, 78205
Research Site
San Antonio, Texas, 78215
Research Site
San Antonio, Texas, 78229
Research Site
Southgate, Michigan, 48195
Research Site
Springfield, Massachusetts, 01107
Research Site
Sumter, South Carolina, 29150
Research Site
The Bronx, New York, 10461
Research Site
Tupelo, Mississippi, 38801
Research Site
Tyler, Texas, 75701
Research Site
Whittier, California, 90603
Research Site
Yonkers, New York, 10704
United Kingdom7 sites
Research Site
Cambridge, CB2 2QQ
Research Site
Coventry, CV2 2DX
Research Site
Glasgow, G11 6NT
Research Site
London, NW3 2QG
Research Site
Nottingham, NG5 1PB
Research Site
Salford, M6 8HD
Research Site
Sheffield, S5 7AU
Hungary6 sites
Research Site
Baja, 6500
Research Site
Budapest, 1037
Research Site
Budapest, 1115
Research Site
Győr, 9023
Research Site
Kaposvár, 7400
Research Site
Pécs, 7624
Poland6 sites
Research Site
Bialystok, 15-540
Research Site
Warsaw, 02-006
Research Site
Warsaw, 02-097
Research Site
Warsaw, 04-141
Research Site
Wroclaw, 51-124
Research Site
Zamość, 87-100
Belgium5 sites
Research Site
Aalst, 9300
Research Site
Baudour, 7331
Research Site
Brussels, 1020
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Leuven, 3000
Research Site
Liège, 4000
Czechia5 sites
Research Site
Hradec Králové, 500 05
Research Site
Prague, 169 00
Research Site
Praha 4 - Nusle, 140 00
Research Site
Slavkov u Brna, 684 01
Research Site
Třinec, 739 61
France5 sites
Research Site
Nantes, 44200
Research Site
Poitiers, 86021
Research Site
Reims, 51092
Research Site
Saint-Ouen, 93400
Research Site
Salouël, 80054
Italy5 sites
Research Site
Milan, 20122
Research Site
Naples, 80131
Research Site
Pavia, 27100
Research Site
San Fermo Della Battaglia (CO), 22020
Research Site
Verona, 37126
Russia5 sites
Research Site
Saint Petersburg, 191104
Research Site
Saint Petersburg, 195067
Research Site
Saint Petersburg, 195257
Research Site
Saint Petersburg, 196247
Research Site
Saint Petersburg, 198510
Spain5 sites
Research Site
Barcelona, Catalonia, 08003
Research Site
Barcelona, Catalonia, 08025
Research Site
Madrid, 28041
Research Site
Madrid, 28046
Research Site
Santander, Cantabria, 39008
Australia4 sites
Research Site
Liverpool, New South Wales, 2170
Research Site
Parkville, Victoria, 3050
Research Site
Prahan, Victoria, 3004
Research Site
St Leonards, New South Wales, 2065
Canada4 sites
Research Site
Brampton, Ontario, L6R 3J7
Research Site
Greenfield Park, Quebec, J4V 2H1
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Québec, Quebec, G1R 2J6
Germany4 sites
Research Site
Berlin, 12053
Research Site
Dresden, 01307
Research Site
Kiel, 24105
Research Site
Villingen-Schwenningen, 78052
Austria3 sites
Research Site
Graz, 8036
Research Site
Linz, 4010
Research Site
Vienna, 1090
Israel3 sites
Research Site
Ashkelon, 78278
Research Site
Nahariya, 22100
Research Site
Tel Aviv, 64239
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.
- Conditions
- Hyperparathyroidism, Secondary
- Being tested
- Etelcalcetide, Placebo
- Keywords
- Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtelcalcetideDrug
Also called AMG 416, KAI-4169
Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at 4-week intervals by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.
PlaceboDrug
Administered intravenously (IV) three times per week.
| Study group | Role | What they receive |
|---|---|---|
| Etelcalcetide | Experimental | Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, for 26 weeks. Receives: Drug: Etelcalcetide |
| Placebo | Placebo comparator | Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase
Participants who did not have any scheduled assessments during the EAP were considered non-responders.
Measured: Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).
Secondary outcomes (5)
Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
Participants who had no scheduled assessments during the EAP were considered non-responders.
Measured: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase
Measured: Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase
Measured: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase
Measured: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase
Measured: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study start12 Mar 2013
- Primary completion22 May 2014
- Study completion12 Jun 2014
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 (9)Papers the sponsor has linked to this study.
- Other trials for Hyperparathyroidism, SecondaryStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 508 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
- NCT01785849
- Sponsor's protocol ID
- 20120229
- Other IDs
- KAI-4169-006, 2012-002805-23
- Status last verified
- Aug 2019
- First submitted
- 5 Feb 2013
- Last updated
- 26 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.
PubMed 28097355Kroenke MA, Weeraratne DK, Deng H, Sloey B, Subramanian R, Wu B, Serenko M, Hock MB. Clinical immunogenicity of the d-amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments. J Immunol Methods. 2017 Jun;445:37-44. doi: 10.1016/j.jim.2017.03.005. Epub 2017 Mar 6.
PubMed 28274835Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.
PubMed 29392552Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.
PubMed 28803497Chen P, Narayanan A, Wu B, Gisleskog PO, Gibbs JP, Chow AT, Melhem M. Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis. Clin Pharmacokinet. 2018 Jan;57(1):71-85. doi: 10.1007/s40262-017-0550-4.
PubMed 28508378Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.
PubMed 30875390Cunningham J, Block GA, Chertow GM, Cooper K, Evenepoel P, Iles J, Sun Y, Urena-Torres P, Bushinsky DA. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019 Apr 16;4(7):987-994. doi: 10.1016/j.ekir.2019.04.010. eCollection 2019 Jul.
PubMed 31317120Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.
PubMed 32082556Hain D, Tomlin H, Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrol Nurs J. 2019 May-Jun;46(3):315-290.
PubMed 31199098
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
- ClinicalTrials.gov ID
- NCT01785849
- Acronym / sponsor ID
- 20120229
- Conditions
- Hyperparathyroidism, Secondary
- Keywords
- Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2013 (actual)
- Primary completion
- 22 May 2014 (actual)
- Study completion
- 12 Jun 2014 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Posted 27 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etelcalcetide | Experimental | Drug: EtelcalcetideParticipants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, for 26 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Subject is 18 years of age or older.
- Subject must be receiving hemodialysis 3 times weekly for at least 3 months
- Subject agrees to not participate in another study of an investigational agent during the study.
- Other Inclusion Criteria may apply
Key exclusion criteria (10 listed)
- Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
- Other investigational procedures while participating in this study are excluded.
- Anticipated or scheduled parathyroidectomy during the study period.
- Subject has received a parathyroidectomy within 3 months prior to dosing.
- Anticipated or scheduled kidney transplant during the study period.
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, KAI-4169Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at 4-week intervals by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg. | Drug | Etelcalcetide |
| PlaceboAdministered intravenously (IV) three times per week. | Drug | Placebo |
Primary outcome
Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase
Time frame: Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).
Participants who did not have any scheduled assessments during the EAP were considered non-responders.
5 secondary outcomes
Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
Time frame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase
Time frame: Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase
Time frame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase
Time frame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase
Time frame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28097355Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.
- Background: PubMed 28274835Kroenke MA, Weeraratne DK, Deng H, Sloey B, Subramanian R, Wu B, Serenko M, Hock MB. Clinical immunogenicity of the d-amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments. J Immunol Methods. 2017 Jun;445:37-44. doi: 10.1016/j.jim.2017.03.005. Epub 2017 Mar 6.
- Background: PubMed 29392552Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.
- Background: PubMed 28803497Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.
- Background: PubMed 28508378Chen P, Narayanan A, Wu B, Gisleskog PO, Gibbs JP, Chow AT, Melhem M. Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis. Clin Pharmacokinet. 2018 Jan;57(1):71-85. doi: 10.1007/s40262-017-0550-4.
- Background: PubMed 30875390Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.
- Background: PubMed 31317120Cunningham J, Block GA, Chertow GM, Cooper K, Evenepoel P, Iles J, Sun Y, Urena-Torres P, Bushinsky DA. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019 Apr 16;4(7):987-994. doi: 10.1016/j.ekir.2019.04.010. eCollection 2019 Jul.
- Background: PubMed 32082556Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.
- Background: PubMed 31199098Hain D, Tomlin H, Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrol Nurs J. 2019 May-Jun;46(3):315-290.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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
118 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etelcalcetide in people with Hyperparathyroidism, Secondary, run by Amgen at 118 sites in 15 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 5 inclusion and 10 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 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 118 sites in United States, United Kingdom, Hungary, Poland, Belgium and 10 more countries. 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 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 27 Mar 2017). 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 a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase (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?
On the ClinicalTrials.gov record for NCT01785849, which also lists 9 linked publications.
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 26 Aug 2019.