Hyperparathyroidism, SecondaryPhase 3NCT02102204

Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

A Phase 3 study testing Etelcalcetide in people with Hyperparathyroidism, Secondary, run by Amgen at 228 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis. Read more about this study

Who is it for?: Ages 18 to 110 years
Conditions the study is for: Hyperparathyroidism, Secondary
What is being tested?: Etelcalcetide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 902 participants
Where: 228 sitesin 24 countries
Study dates: 25 Mar 2014to 26 Jun 2017
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 110 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
Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)
Female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study
Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months

Who cannot join

Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies)
Subject has known sensitivity to any of the products or components to be administered during dosing
Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study
Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L
Subject is pregnant or nursing

Trial locations and contacts

228 sites in 24 countries.

Country

City, postcode or hospital

228 sites in 24 countries

United States68 sites

Research Site
Alhambra, California, 91801
Research Site
Arlington, Texas, 76015
Research Site
Augusta, Georgia, 30909
Research Site
Aurora, Colorado, 80045
Research Site
Azusa, California, 91702
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Bakersfield, California, 93308
Research Site
Baton Rouge, Louisiana, 70808
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Bethlehem, Pennsylvania, 18017
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Birmingham, Alabama, 35211
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Bluefield, West Virginia, 24701
Research Site
Brookhaven, Mississippi, 39601
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Brooklyn, New York, 11235
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Burlington, Vermont, 05401
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Chattanooga, Tennessee, 37408
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Cincinnati, Ohio, 45267
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College Point, New York, 11356
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Columbia, South Carolina, 29203
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Columbus, Mississippi, 39705
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Columbus, Ohio, 43215
Research Site
Cudahy, California, 90201
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Detroit, Michigan, 48236
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Dublin, Georgia, 31021
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Durham, North Carolina, 27704
Research Site
Eatontown, New Jersey, 07724
Research Site
Edinburg, Texas, 78539
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Fairfax, Virginia, 22033
Research Site
Granada Hills, California, 91344
Research Site
Great Neck, New York, 11021
Research Site
Gulfport, Mississippi, 39501
Research Site
Hampton, Virginia, 23666
Research Site
Highland Park, Illinois, 60035
Research Site
Houston, Texas, 77030
Research Site
Kansas City, Missouri, 64111
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Knoxville, Tennessee, 37923
Research Site
Las Vegas, Nevada, 89106
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Lincoln, Nebraska, 68510
Research Site
Los Angeles, California, 90022
Research Site
Los Angeles, California, 90048
Research Site
Mechanicsville, Virginia, 23116
Research Site
Meridian, Idaho, 83642
Research Site
Merrillville, Indiana, 46410
Research Site
Miami, Florida, 33150
Research Site
Michigan City, Indiana, 46360
Research Site
Mineola, New York, 11501
Research Site
New Bern, North Carolina, 28562
Research Site
Northridge, California, 91324
Research Site
Ocala, Florida, 34471
Research Site
Oklahoma City, Oklahoma, 73116
Research Site
Pembroke Pines, Florida, 33028
Research Site
Philadelphia, Pennsylvania, 19106
Research Site
Pontiac, Michigan, 48341
Research Site
Reno, Nevada, 89511
Research Site
Riverside, California, 92501
Research Site
Rosedale, New York, 11422
Research Site
San Antonio, Texas, 78229
Research Site
Simi Valley, California, 93065
Research Site
Springfield, Massachusetts, 01107
Research Site
Stamford, Connecticut, 06902
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Tampa, Florida, 33614
Research Site
The Bronx, New York, 10461
Research Site
Tupelo, Mississippi, 38801
Research Site
Vacaville, California, 95687
Research Site
Voorhees Township, New Jersey, 08043
Research Site
Westminster, Colorado, 80031
Research Site
Whittier, California, 90603
Research Site
Wichita, Kansas, 67214-2998
Research Site
Wilmington, North Carolina, 28401
Research Site
Yonkers, New York, 10704

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Poland14 sites

Research Site
Gdansk, 80-952
Research Site
Golub-Dobrzyń, 87-400
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Katowice, 40-027
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Krakow, 31-501
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Lodz, 90-153
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Poznan, 60-355
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Poznan, 61-696
Research Site
Sieradz, 98-200
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Wadowice, 34-100
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Warsaw, 02-097
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Warsaw, 02-507
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Zabrze, 41-800
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Zamość, 87-100
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Żyrardów, 96-300

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Spain14 sites

Research Site
Badajoz, Extremadura, 06080
Research Site
Barcelona, Catalonia, 08003
Research Site
Barcelona, Catalonia, 08025
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Barcelona, Catalonia, 08035
Research Site
Barcelona, Catalonia, 08036
Research Site
Córdoba, Andalusia, 14004
Research Site
Lleida, Catalonia, 25198
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Majadahonda, Madrid, 28222
Research Site
Pamplona, Navarre, 31008
Research Site
Santander, Cantabria, 39008
Research Site
Torrevieja, Valencia, 03186
Research Site
Valencia, Valencia, 46017

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Hungary12 sites

Research Site
Baja, 6500
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Budapest, 1106
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Esztergom, 2500
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Győr, 9023
Research Site
Kaposvár, 7400
Research Site
Kistarcsa, 2143
Research Site
Miskolc, 3526
Research Site
Pécs, 7624
Research Site
Pécs, 7633
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Székesfehérvár, 8000
Research Site
Szigetvár, 7900
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Zalaegerszeg, 8900

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Belgium11 sites

Research Site
Aalst, 9300
Research Site
Baudour, 7331
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Bonheiden, 2820
Research Site
Brussels, 1020
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Brussels, 1200
Research Site
Hasselt, 3500
Research Site
Kortrijk, 8500
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Roeselare, 8800
Research Site
Tournai, 7500

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Russia11 sites

Research Site
Mitishi, 141009
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, 195257
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Saint Petersburg, 196247
Research Site
Saint Petersburg, 197110
Research Site
Saint Petersburg, 198510
Research Site
Yaroslavl, 150062

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Italy10 sites

Research Site
Ancona, 60126
Research Site
Florence, 50139
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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
Verona, 37126

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France9 sites

Research Site
Caen, 14000
Research Site
La Tronche, 38701
Research Site
Lille, 59800
Research Site
Marseille, 13253
Research Site
Paris, 75011
Research Site
Paris, 75014
Research Site
Reims, 51092
Research Site
Saint-Ouen, 93400
Research Site
Saint-Priest-en-Jarez, 42270

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Germany9 sites

Research Site
Aachen, 52074
Research Site
Berlin, 12053
Research Site
Hamburg, 22297
Research Site
Langenhagen, 30853
Research Site
Minden, 32429
Research Site
München, 81675
Research Site
Villingen-Schwenningen, 78052
Research Site
Wiesbaden, 65191
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Zwickau, 08060

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Czechia8 sites

Research Site
Hradec Králové, 500 05
Research Site
Nový Jičín, 741 01
Research Site
Pilsen, 301 00
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Prague, 140 21
Research Site
Prague, 169 00
Research Site
Praha 4 - Nusle, 140 00
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Slavkov u Brna, 684 01
Research Site
Ústí nad Orlicí, 562 18

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Portugal8 sites

Research Site
Almada, 2800-455
Research Site
Aveiro, 3800-266
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Forte Da Casa, 2625-437
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Guimarães, 4810-273
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Lisbon, 1750-130
Research Site
Santo Tirso, 4780-383
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Setúbal, 2900-655
Research Site
Vila Franca de Xira, 2600-076

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Switzerland7 sites

Research Site
Aarau, 5001
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Bern, 3010
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Geneva, 1211
Research Site
Lausanne, 1003
Research Site
Lausanne, 1011
Research Site
Locarno, 6600
Research Site
Zurich, 8091

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Australia6 sites

Research Site
Adelaide, South Australia, 5000
Research Site
Brisbane, Queensland, 4102
Research Site
Clayton, Victoria, 3168
Research Site
Liverpool, New South Wales, 2170
Research Site
Prahan, Victoria, 3004
Research Site
Westmead, New South Wales, 2145

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Canada6 sites

Research Site
Brampton, Ontario, L6R 3J7
Research Site
Edmonton, Alberta, T6G 2B7
Research Site
Greenfield Park, Quebec, J4V 2H1
Research Site
Montreal, Quebec, H4J 1C5
Research Site
Saint John, New Brunswick, E2L 4L2
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6

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Austria5 sites

Research Site
Feldkirch, 6807
Research Site
Graz, 8036
Research Site
Linz, 4020
Research Site
Vienna, 1090
Research Site
Vienna, 1220

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Greece5 sites

Research Site
Alexandroupoli, 68100
Research Site
Larissa, 41110
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Nikaia, Piraeus, 18454
Research Site
Pátrai, 26500
Research Site
Thessaloniki, 54636

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Israel5 sites

Research Site
Ashkelon, 78278
Research Site
Jerusalem, 91120
Research Site
Tel Aviv, 64239
Research Site
Tel HaShomer, 52621
Research Site
Tsrifin, 70300

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Sweden5 sites

Research Site
Karlstad, 651 85
Research Site
Stockholm, 118 67
Research Site
Stockholm, 141 86
Research Site
Trollhättan, 467 85
Research Site
Uppsala, 751 85

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Turkey (Türkiye)5 sites

Research Site
Ankara, 06230
Research Site
Ankara, 06810
Research Site
Istanbul, 34371
Research Site
Istanbul, 34890
Research Site
Izmir, 35100

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Lithuania4 sites

Research Site
Alytus, 63351
Research Site
Kaunas, 50009
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Kaunas, 50169
Research Site
Ukmerge, 20184

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Denmark2 sites

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Copenhagen, 2100
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Fredericia, 7000

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Netherlands2 sites

Research Site
Rotterdam, 3079 DZ
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Venlo, 5912 BL

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Latvia1 site

Research Site
Riga, 1001

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New Zealand1 site

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Hamilton, 3240

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About this study

Official title: A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

Read the detailed description

This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.

Conditions: Hyperparathyroidism, Secondary
Being tested: Etelcalcetide
Keywords: Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis
Medical subject headings: Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EtelcalcetideDrug
Also called KAI-4169, AMG 416, Parasabiv
Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.

Study groups in NCT02102204
Study group	Role	What they receive
Etelcalcetide	Experimental	Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center. Receives: Drug: Etelcalcetide

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
A serious adverse event is an AE that met at least 1 of the following criteria:
- fatal
- life threatening
- required in-patient hospitalization or prolongation of existing hospitalization
- resulted in persistent or significant disability/incapacity
- congenital anomaly/birth defect
- other medically important serious event.
The relationship of each AE to study treatment was assessed by the investigator.
The following AE grading scale was used:
Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable.
Measured: From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.

Secondary outcomes (5)

Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal
The percentage of participants who maintained plasma parathyroid hormone (PTH) levels within the Kidney Disease Improving Global Outcomes (KDIGO) recommended range of not less than 2x the upper limit of normal (ULN) and not greater than 9x the ULN at months 6, 12, and 18, with the ULN based on the reference range of the assay used at the individual clinical site.
Measured: Months 6, 12, and 18
Percentage of Participants With Serum Phosphorus ≤ the ULN
Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.
Measured: Months 6, 12, and 18
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL
The percentage of participants with serum corrected calcium (cCa) reported for cumulative time intervals from day 1 through months 6, 12, and 18, using the participant's lowest recorded corrected calcium value during the time interval.
If serum albumin was less than 4.0 g/dL, serum calcium was corrected according to the following formula:
cCa (mg/dL) = total calcium (mg/dL) + (4 - albumin [g/dL])*0.8. If serum albumin was > 4.0 g/dL no correction was made.
Measured: From day 1 to months 6, 12, and 18
Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters
The Common Terminology Criteria for Adverse Events (CTCAE) grades for laboratory parameter values were defined based on the upper/lower limit of normal from the local laboratories contracted by the study centers.
Measured: Baseline to end of treatment; median duration of treatment was 563 days.
Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies
The number of participants who were binding antibody positive post-baseline with a negative or no result at baseline (where baseline for participants previously treated with etelcalcetide is Day 1 of the first study in which they were exposed to etelcalcetide and for participants previously treated with cinacalcet is the ending time point for study 20120360).
Measured: Baseline and every 6 months (up to 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Mar 201426 Jun 2017

First posted2 Apr 2014 (estimated)
Study start25 Mar 2014
Primary completion4 Nov 2016
Study completion26 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 902 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02102204
Sponsor's protocol ID: 20130213
Other IDs: 2013-004136-30, KAI-4169
Status last verified: Oct 2017
First submitted: 3 Mar 2014
Last updated: 17 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
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All Hyperparathyroidism, Secondary trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis
ClinicalTrials.gov ID: NCT02102204
Acronym / sponsor ID: 20130213
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 902 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 25 Mar 2014 (actual)
Primary completion: 4 Nov 2016 (actual)
Study completion: 26 Jun 2017 (actual)
First posted: 2 Apr 2014 (estimated)
Results: Posted 17 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Etelcalcetide	Experimental	Drug: EtelcalcetideParticipants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.

Who may qualify

Ages: 18 to 110 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject has provided informed consent prior to initiation of any study-specific activities/procedures
Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)
Female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study
Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months

Key exclusion criteria (5 listed)

Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies)
Subject has known sensitivity to any of the products or components to be administered during dosing
Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study
Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L
Subject is pregnant or nursing

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: KAI-4169, AMG 416, ParasabivEtelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.	Drug	Etelcalcetide

Primary outcome

Number of Participants With Adverse Events
Time frame: From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.
A serious adverse event is an AE that met at least 1 of the following criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event. The relationship of each AE to study treatment was assessed by the investigator. The following AE grading scale was used: Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable.

5 secondary outcomes

Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal
Time frame: Months 6, 12, and 18
Percentage of Participants With Serum Phosphorus ≤ the ULN
Time frame: Months 6, 12, and 18
Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL
Time frame: From day 1 to months 6, 12, and 18
Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters
Time frame: Baseline to end of treatment; median duration of treatment was 563 days.
Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies
Time frame: Baseline and every 6 months (up to 24 months)

Results and safety

Results posted to the registry on 17 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etelcalcetide	902	598

Primary outcome: Number of Participants With Adverse Events

Time frame: From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.. Number. Unit: participants

Measure	Etelcalcetide n = 884
Any adverse event	768
Serious adverse events	436
Treatment-related adverse events	287
Serious treatment-related adverse events	4
AEs leading to discontinuation of etelcalcetide	41
Fatal adverse events	89
Mild adverse events	123
Moderate adverse events	219

Population analysed: Participants who received at least 1 dose of etelcalcetide in the current study (20130213).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etelcalcetide	436 of 884 (49.3%)	519 of 884 (58.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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
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REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
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Not yet recruitingPhase 3
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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

228 sites in 24 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 228 sites in 24 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 5 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 228 sites in United States, Poland, Spain, Hungary, Belgium and 19 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 17 Nov 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?

Number of Participants With Adverse Events (time frame: From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.). 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 NCT02102204.

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 17 Nov 2017.