Secondary HyperparathyroidismPhase 3NCT01896232
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
A Phase 3 study testing Etelcalcetide and Cinacalcet in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by Amgen at 182 sites in 22 countries.
Trial summary
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- 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?
- Yes, some participants may receive a placebo
- How many people
- 683 participants
- Where
- 182 sitesin 22 countries
- Study dates
- 13 Aug 2013to 8 Jan 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to screening laboratory assessments
- Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, measured on separate days within 2 weeks prior to randomization
- Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization
- Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization
Who cannot join
- Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment
- Other criteria may apply
Trial locations and contacts
182 sites in 22 countries.
182 sites in 22 countries
United States41 sites
Research Site
Arvada, Colorado, 80002
Research Site
Aurora, Colorado, 80045
Research Site
Azusa, California, 91702
Research Site
Bakersfield, California, 93306
Research Site
Bakersfield, California, 93309
Research Site
Baton Rouge, Louisiana, 70808
Research Site
Burlington, Vermont, 05401
Research Site
Chula Vista, California, 91910
Research Site
Cincinnati, Ohio, 45206
Research Site
Columbus, Mississippi, 39705
Research Site
Columbus, Ohio, 43215
Research Site
Covina, California, 91723
Research Site
Fairfax, Virginia, 22033
Research Site
Granada Hills, California, 91344
Research Site
Great Neck, New York, 11021
Research Site
Gulfport, Mississippi, 39501
Research Site
Houston, Texas, 77030
Research Site
La Mesa, California, 91942
Research Site
La Puente, California, 91744
Research Site
Lafayette, Louisiana, 70501
Research Site
Longmont, Colorado, 80501
Research Site
Los Angeles, California, 90022
Research Site
Madison, Wisconsin, 53713
Research Site
Mineola, New York, 11501
Research Site
Orange, Connecticut, 06477
Research Site
Pembroke Pines, Florida, 33028
Research Site
Philadelphia, Pennsylvania, 19106
Research Site
Pinecrest, Florida, 33156
Research Site
Portsmouth, Virginia, 23704
Research Site
Ridgewood, New York, 11385
Research Site
Rosedale, New York, 11422
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92123
Research Site
San Gabriel, California, 91776
Research Site
Sewell, New Jersey, 08080
Research Site
Southgate, Michigan, 48195
Research Site
Tampa, Florida, 33614
Research Site
The Bronx, New York, 10461
Research Site
Westminster, Colorado, 80031
Research Site
Whittier, California, 90603
Research Site
Wilmington, North Carolina, 28401
Spain11 sites
Research Site
Badajoz, Extremadura, 06080
Research Site
Badalona, Catalonia, 08916
Research Site
Córdoba, Andalusia, 14004
Research Site
Galdakao, Basque Country, 48960
Research Site
Lleida, Catalonia, 25198
Research Site
Madrid, 28007
Research Site
Madrid, 28040
Research Site
Pamplona, Navarre, 31008
Research Site
Puerto Real, Andalusia, 11510
Research Site
Torrevieja, Valencia, 03186
Research Site
Valencia, Valencia, 46017
Germany10 sites
Research Site
Aachen, 52074
Research Site
Coburg, 96450
Research Site
Hamburg, 22297
Research Site
Hanover, 30625
Research Site
Magdeburg, 39120
Research Site
Mettmann, 40822
Research Site
Minden, 32429
Research Site
München, 81675
Research Site
Wiesbaden, 65191
Research Site
Zwickau, 08060
Italy10 sites
Research Site
Cagliari, 09134
Research Site
Florence, 50139
Research Site
Genova, 16132
Research Site
Lecco, 23900
Research Site
Lucca, 55100
Research Site
Milan, 20122
Research Site
Pavia, 27100
Research Site
Pisa, 56126
Research Site
Pordenone, 33170
Research Site
San Giovanni Rotondo FG, 71013
Poland10 sites
Research Site
Gdansk, 80-104
Research Site
Katowice, 40-027
Research Site
Poznan, 60-355
Research Site
Poznan, 61-696
Research Site
Sieradz, 98-200
Research Site
Wadowice, 34-100
Research Site
Warsaw, 01-211
Research Site
Warsaw, 02-507
Research Site
Zabrze, 41-800
Research Site
Żyrardów, 96-300
Russia10 sites
Research Site
Mitishi, 141009
Research Site
Moscow, 123182
Research Site
Moscow, 129327
Research Site
Petrozavodsk, 185019
Research Site
Saint Petersburg, 191104
Research Site
Saint Petersburg, 193318
Research Site
Saint Petersburg, 195067
Research Site
Saint Petersburg, 197110
Research Site
Saint Petersburg, 198510
Research Site
Yaroslavl, 150062
Hungary9 sites
Research Site
Budapest, 1115
Research Site
Győr, 9023
Research Site
Kaposvár, 7400
Research Site
Kistarcsa, 2143
Research Site
Pécs, 7624
Research Site
Pécs, 7633
Research Site
Székesfehérvár, 8000
Research Site
Szigetvár, 7900
Research Site
Zalaegerszeg, 8900
Portugal9 sites
Research Site
Almada, 2800-455
Research Site
Aveiro, 3800-266
Research Site
Estoril, 2765-294
Research Site
Forte Da Casa, 2625-437
Research Site
Guimarães, 4810-273
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Lisbon, 1750-130
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Santo Tirso, 4780-383
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Setúbal, 2900-655
Research Site
Vila Franca de Xira, 2600-076
France8 sites
Research Site
Boulogne-sur-Mer, 62200
Research Site
Lille, 59800
Research Site
Nouilly, 57645
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Paris, 75011
Research Site
Paris, 75014
Research Site
Saint-Ouen, 93400
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Sainte-Foy-lès-Lyon, 66046
Turkey (Türkiye)8 sites
Research Site
Ankara, 06230
Research Site
Ankara, 06500
Research Site
Ankara, 06810
Research Site
Istanbul, 34371
Research Site
Istanbul, 34890
Research Site
Izmir, 35100
Research Site
Izmir, 35340
Research Site
Izmir, 35360
Greece7 sites
Research Site
Alexandroupoli, 68100
Research Site
Athens, 11528
Research Site
Ioannina, 45500
Research Site
Larissa, 41110
Research Site
Nikaia, Piraeus, 18454
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Pátrai, 26500
Research Site
Thessaloniki, 54636
Lithuania7 sites
Research Site
Alytus, 63351
Research Site
Kaunas, 50009
Research Site
Kaunas, 50169
Research Site
Kėdainiai, 57164
Research Site
Klaipėda, LT-93220
Research Site
Šiauliai, 76299
Research Site
Ukmerge, 20184
Switzerland7 sites
Research Site
Aarau, 5001
Research Site
Bern, 3010
Research Site
Geneva, 1211
Research Site
Lausanne, 1003
Research Site
Lausanne, 1011
Research Site
Locarno, 6600
Research Site
Zurich, 8091
Czechia6 sites
Research Site
Nový Jičín, 741 01
Research Site
Prague, 169 00
Research Site
Praha 4 - Nusle, 140 00
Research Site
Slavkov u Brna, 684 01
Research Site
Třinec, 739 61
Research Site
Ústí nad Orlicí, 562 18
Canada5 sites
Research Site
Brampton, Ontario, L6R 3J7
Research Site
Edmonton, Alberta, T6G 2B7
Research Site
Greenfield Park, Quebec, J4V 2H1
Research Site
Saint John, New Brunswick, E2L 4L2
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6
Denmark5 sites
Research Site
Aalborg, 9000
Research Site
Copenhagen, 2100
Research Site
Fredericia, 7000
Research Site
Odense, 5000
Research Site
Roskilde, 4000
Belgium4 sites
Research Site
Genk, 3600
Research Site
Hasselt, 3500
Research Site
Kortrijk, 8500
Research Site
Roeselare, 8800
Austria3 sites
Research Site
Feldkirch, 6807
Research Site
Linz, 4010
Research Site
Vienna, 1220
Estonia3 sites
Research Site
Tallinn, 10617
Research Site
Tallinn, 13419
Research Site
Tartu, 51014
Latvia3 sites
Research Site
Riga, 1001
Research Site
Riga, 1038
Research Site
Valmiera, 4201
New Zealand3 sites
Research Site
Hamilton, 3240
Research Site
Papatoetoe, Auckland, 2025
Research Site
Takapuna, Auckland City, 0622
Sweden3 sites
Research Site
Malmö, 205 02
Research Site
Stockholm, 118 67
Research Site
Trollhättan, 467 85
About this study
Official title: A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
- Being tested
- Etelcalcetide, Cinacalcet, Oral Placebo, Intravenous Placebo
- Keywords
- Secondary Hyperparathyroidism, renal, kidney, kidneys, dialysis, hemodialysis, chronic kidney disease, CKD, SHPT
- 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
Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.
CinacalcetDrug
Also called Sensipar®, Mimpara®
Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.
Oral PlaceboDrug
Administered orally once a day.
Intravenous PlaceboDrug
Administered intravenously (IV) three times per week.
| Study group | Role | What they receive |
|---|---|---|
| Cinacalcet | Active comparator | Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could 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 corrected calcium (cCa) ≥ 8.3 mg/dL. Receives: Drug: Cinacalcet; Drug: Intravenous Placebo |
| 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 could 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; Drug: Oral Placebo |
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 Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
Measured: Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).
Secondary outcomes (7)
Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase
Measured: Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).
Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase
Measured: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks
Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was > 0 or where the episodes of vomiting score was > 0.
Measured: First 8 weeks
Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase
Measured: Baseline and the efficacy assessment phase (weeks 20 - 27)
Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase
Measured: Efficacy assessment phase (weeks 20 - 27)
Mean Severity of Nausea in the First 8 Weeks
Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.
Measured: First 8 weeks
Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks
The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week.
For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.
Measured: First 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study start13 Aug 2013
- Primary completion12 Nov 2014
- Study completion8 Jan 2015
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 (6)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 683 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
- NCT01896232
- Sponsor's protocol ID
- 20120360
- Other IDs
- 2013-000192-33
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2013
- Last updated
- 18 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Block GA, Bushinsky DA, Cheng S, Cunningham J, Dehmel B, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Moe SM, Patel UD, Silver J, Sun Y, Wang H, Chertow GM. Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial. JAMA. 2017 Jan 10;317(2):156-164. doi: 10.1001/jama.2016.19468.
PubMed 28097356Stollenwerk 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 28803497Wu B, Melhem M, Subramanian R, Chen P, Jaramilla Sloey B, Fouqueray B, Hock MB, Skiles GL, Chow AT, Lee E. Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis. J Clin Pharmacol. 2018 Jun;58(6):717-726. doi: 10.1002/jcph.1090. Epub 2018 Mar 13.
PubMed 29534286Block 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 30875390Wolf 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 32082556
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT01896232
- Acronym / sponsor ID
- 20120360
- Keywords
- Secondary Hyperparathyroidism, renal, kidney, kidneys, dialysis, hemodialysis, chronic kidney disease, CKD, SHPT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 683 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2013 (actual)
- Primary completion
- 12 Nov 2014 (actual)
- Study completion
- 8 Jan 2015 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Posted 8 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients 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
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinacalcet | Active comparator | Drug: Cinacalcet, Drug: Intravenous PlaceboParticipants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could 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 corrected calcium (cCa) ≥ 8.3 mg/dL. |
| Etelcalcetide | Experimental | Drug: Etelcalcetide, Drug: Oral PlaceboParticipants 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 could 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 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to screening laboratory assessments
- Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, measured on separate days within 2 weeks prior to randomization
- Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization
- Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization
Key exclusion criteria (2 listed)
- Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment
- Other criteria may apply
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, titrated up to 15 mg based on serum PTH and corrected calcium levels. | Drug | Etelcalcetide |
| CinacalcetAlso: Sensipar®, Mimpara®Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels. | Drug | Cinacalcet |
| Oral PlaceboAdministered orally once a day. | Drug | Etelcalcetide |
| Intravenous PlaceboAdministered intravenously (IV) three times per week. | Drug | Cinacalcet |
Primary outcome
Percentage of Participants With > 30% Reduction From Baseline in Mean 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).
7 secondary outcomes
Percentage of Participants With > 50% Reduction From Baseline in Mean PTH 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 PTH During the Efficacy Assessment Phase
Time frame: Baseline and the efficacy assessment phase (Week 20 to Week 27)
Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks
Time frame: First 8 weeks
Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase
Time frame: Baseline and the efficacy assessment phase (weeks 20 - 27)
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)
Mean Severity of Nausea in the First 8 Weeks
Time frame: First 8 weeks
Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks
Time frame: First 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28097356Block GA, Bushinsky DA, Cheng S, Cunningham J, Dehmel B, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Moe SM, Patel UD, Silver J, Sun Y, Wang H, Chertow GM. Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial. JAMA. 2017 Jan 10;317(2):156-164. doi: 10.1001/jama.2016.19468.
- 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 29534286Wu B, Melhem M, Subramanian R, Chen P, Jaramilla Sloey B, Fouqueray B, Hock MB, Skiles GL, Chow AT, Lee E. Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis. J Clin Pharmacol. 2018 Jun;58(6):717-726. doi: 10.1002/jcph.1090. Epub 2018 Mar 13.
- 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 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.
- 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
182 sites in 22 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 182 sites in 22 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 4 inclusion and 2 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 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 182 sites in United States, Spain, Germany, Italy, Poland and 17 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. 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 8 Feb 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% Reduction From Baseline in Mean 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?
On the ClinicalTrials.gov record for NCT01896232, which also lists 6 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 18 Jul 2019.