Hyperparathyroidism, SecondaryPhase 3NCT01788046
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
A Phase 3 study testing Etelcalcetide in people with Hyperparathyroidism, Secondary, run by Amgen at 106 sites in 15 countries.
Trial summary
This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients 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
- 515 participants
- Where
- 106 sitesin 15 countries
- Study dates
- 12 Mar 2013to 9 May 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 agrees to not participate in another study of an investigational agent during the study.
- Subject must be receiving hemodialysis 3 times weekly for at least 3 months
- 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
- 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.
- Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
- Other Exclusion Criteria may apply
Trial locations and contacts
106 sites in 15 countries.
106 sites in 15 countries
United States45 sites
Research Site
Alexandria, Virginia, 22304
Research Site
Arlington, Texas, 76015
Research Site
Augusta, Georgia, 30901
Research Site
Azusa, California, 91702
Research Site
Bethesda, Maryland, 20817
Research Site
Beverly Hills, California, 90211
Research Site
Brookhaven, Mississippi, 39601
Research Site
Brooklyn, New York, 11212
Research Site
Charlotte, North Carolina, 28207
Research Site
Chattanooga, Tennessee, 37408
Research Site
Chicago, Illinois, 60616
Research Site
Chula Vista, California, 91910
Research Site
Cincinnati, Ohio, 45206
Research Site
Columbia, South Carolina, 29203
Research Site
Denver, Colorado, 80230
Research Site
Detroit, Michigan, 48202
Research Site
Eatontown, New Jersey, 07724
Research Site
Fairfield, California, 94534
Research Site
Fresh Meadows, New York, 11365
Research Site
Ft. Washington, Maryland, 20744
Research Site
Glendale, California, 91205
Research Site
Great Neck, New York, 11021
Research Site
Gurnee, Illinois, 60031
Research Site
Houston, Texas, 77054
Research Site
Knoxville, Tennessee, 37923
Research Site
Las Vegas, Nevada, 89106
Research Site
Lauderdale Lakes, Florida, 33313
Research Site
Lincoln, Nebraska, 68510
Research Site
Los Angeles, California, 90022
Research Site
Lubbock, Texas, 79430
Research Site
Macon, Georgia, 31217
Research Site
Merrillville, Indiana, 46410
Research Site
Miami, Florida, 33173
Research Site
Mobile, Alabama, 36608
Research Site
Morgantown, West Virginia, 26506-9165
Research Site
New Bern, North Carolina, 28562
Research Site
Northridge, California, 91324
Research Site
Norwalk, California, 90650
Research Site
Ocala, Florida, 34471
Research Site
Riverside, California, 92501
Research Site
Rutland, Vermont, 05701
Research Site
Shreveport, Louisiana, 71101
Research Site
Simi Valley, California, 93065
Research Site
Stamford, Connecticut, 06902
Research Site
Wichita, Kansas, 67214-2998
Belgium6 sites
Research Site
Bonheiden, 2820
Research Site
Brussels, 1090
Research Site
Brussels, 1200
Research Site
Liège, 4000
Research Site
Roeselare, 8800
Research Site
Tournai, 7500
France6 sites
Research Site
Bordeaux, 33075
Research Site
Caen, 14000
Research Site
Grenoble, 38000
Research Site
Marseille, 13253
Research Site
Marseille, 13385
Research Site
Perpignan, 66046
Hungary6 sites
Research Site
Budapest, 1076
Research Site
Budapest, 1106
Research Site
Esztergom, 2500
Research Site
Kecskemét, 6000
Research Site
Miskolc, 3526
Research Site
Zalaegerszeg, 8900
Poland6 sites
Research Site
Gdansk, 80-952
Research Site
Golub-Dobrzyń, 87-400
Research Site
Krakow, 31-501
Research Site
Lodz, 90-153
Research Site
Rybnik, 44-200
Research Site
Warsaw, 04-749
Canada5 sites
Research Site
Edmonton, Alberta, T6G 2B7
Research Site
Halifax, Nova Scotia, B3H 1V7
Research Site
Montreal, Quebec, H4J 1C5
Research Site
New Westminster, British Columbia, V3L 0A6
Research Site
Toronto, Ontario, M5C 2T2
Spain5 sites
Research Site
Barcelona, Catalonia, 08035
Research Site
Barcelona, Catalonia, 08036
Research Site
Córdoba, Andalusia, 14004
Research Site
Granada, Andalusia, 18012
Research Site
Majadahonda, Madrid, 28222
Australia4 sites
Research Site
Adelaide, South Australia, 5000
Research Site
Brisbane, Queensland, 4102
Research Site
Clayton, Victoria, 3168
Research Site
Westmead, New South Wales, 2145
Czechia4 sites
Research Site
Nový Jičín, 741 01
Research Site
Pilsen, 301 00
Research Site
Prague, 140 21
Research Site
Ústí nad Orlicí, 562 18
Israel4 sites
Research Site
Jerusalem, 91120
Research Site
Kfar Saba, 44281
Research Site
Tel HaShomer, 52621
Research Site
Tsrifin, 70300
Italy4 sites
Research Site
Ancona, 60131
Research Site
Lecco, 23900
Research Site
Milan, 20142
Research Site
Quartu Sant'Elena CA, 09045
Netherlands4 sites
Research Site
Amsterdam, 1081 HV
Research Site
Enschede, 7511 JX
Research Site
Rotterdam, 3079 DZ
Research Site
Venlo, 5912 BL
Russia3 sites
Research Site
Moscow, 123183
Research Site
Saint Petersburg, 197110
Research Site
Yaroslavl, 150062
Sweden3 sites
Research Site
Karlstad, 651 85
Research Site
Stockholm, 141 86
Research Site
Uppsala, 751 85
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 (AMG 416) compared with placebo in the treatment of SHPT in CKD patients 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
Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at weeks 5, 9, 13, and 17 (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 |
|---|---|---|
| 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 |
| Etelcalcetide | Experimental | Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks. 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% 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 (cCa x P) 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 posted11 Feb 2013 (estimated)
- Study start12 Mar 2013
- Primary completion14 Apr 2014
- Study completion9 May 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
- 515 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
- NCT01788046
- Sponsor's protocol ID
- 20120230
- Other IDs
- KAI-4169-007, 2012-002806-31
- Status last verified
- Aug 2019
- First submitted
- 7 Feb 2013
- Last updated
- 20 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 20 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
- NCT01788046
- Acronym / sponsor ID
- 20120230
- 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
- 515 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2013 (actual)
- Primary completion
- 14 Apr 2014 (actual)
- Study completion
- 9 May 2014 (actual)
- First posted
- 11 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 (AMG 416) compared with placebo in the treatment of SHPT in CKD patients 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 |
|---|---|---|
| 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. |
| Etelcalcetide | Experimental | Drug: EtelcalcetideParticipants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session 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 agrees to not participate in another study of an investigational agent during the study.
- Subject must be receiving hemodialysis 3 times weekly for at least 3 months
- 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 416Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at weeks 5, 9, 13, and 17 (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 > 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 (cCa x P) 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 20 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.
Related trials for Hyperparathyroidism, Secondary
RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
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
106 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 106 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 20 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 106 sites in United States, Belgium, France, Hungary, Poland 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 > 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 NCT01788046, 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 20 Aug 2019.