Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01896232
Registration number
NCT01896232
Ethics application status
Date submitted
8/07/2013
Date registered
11/07/2013
Date last updated
18/07/2019
Titles & IDs
Public title
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2013-000192-33
Query!
Secondary ID [2]
0
0
20120360
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Secondary Hyperparathyroidism
0
0
Query!
Chronic Kidney Disease
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Renal and Urogenital
0
0
0
0
Query!
Other renal and urogenital disorders
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Other endocrine disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Etelcalcetide
Treatment: Drugs - Cinacalcet
Treatment: Drugs - Oral Placebo
Treatment: Drugs - Intravenous Placebo
Active comparator: Cinacalcet - 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.
Experimental: Etelcalcetide - 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.
Treatment: Drugs: Etelcalcetide
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.
Treatment: Drugs: Cinacalcet
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.
Treatment: Drugs: Oral Placebo
Administered orally once a day.
Treatment: Drugs: Intravenous Placebo
Administered intravenously (IV) three times per week.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).
Query!
Secondary outcome [1]
0
0
Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).
Query!
Secondary outcome [2]
0
0
Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Baseline and the efficacy assessment phase (Week 20 to Week 27)
Query!
Secondary outcome [3]
0
0
Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
First 8 weeks
Query!
Secondary outcome [4]
0
0
Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Baseline and the efficacy assessment phase (weeks 20 - 27)
Query!
Secondary outcome [5]
0
0
Percentage of Participants With Mean Predialysis Serum Phosphorus = 4.5 mg/dL During the Efficacy Assessment Phase
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Efficacy assessment phase (weeks 20 - 27)
Query!
Secondary outcome [6]
0
0
Mean Severity of Nausea in the First 8 Weeks
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
First 8 weeks
Query!
Secondary outcome [7]
0
0
Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
First 8 weeks
Query!
Eligibility
Key inclusion criteria
* 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment
* Other criteria may apply
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
13/08/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
8/01/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
683
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Louisiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Mississippi
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New Jersey
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Pennsylvania
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Vermont
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Virginia
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Wisconsin
Query!
Country [17]
0
0
Austria
Query!
State/province [17]
0
0
Feldkirch
Query!
Country [18]
0
0
Austria
Query!
State/province [18]
0
0
Linz
Query!
Country [19]
0
0
Austria
Query!
State/province [19]
0
0
Wien
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Genk
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Hasselt
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Kortrijk
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Roeselare
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Alberta
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
New Brunswick
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Newfoundland and Labrador
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Ontario
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Quebec
Query!
Country [29]
0
0
Czechia
Query!
State/province [29]
0
0
Novy Jicin
Query!
Country [30]
0
0
Czechia
Query!
State/province [30]
0
0
Praha 4 - Nusle
Query!
Country [31]
0
0
Czechia
Query!
State/province [31]
0
0
Praha 6
Query!
Country [32]
0
0
Czechia
Query!
State/province [32]
0
0
Slavkov u Brna
Query!
Country [33]
0
0
Czechia
Query!
State/province [33]
0
0
Trinec
Query!
Country [34]
0
0
Czechia
Query!
State/province [34]
0
0
Usti nad Orlici
Query!
Country [35]
0
0
Denmark
Query!
State/province [35]
0
0
Aalborg
Query!
Country [36]
0
0
Denmark
Query!
State/province [36]
0
0
Fredericia
Query!
Country [37]
0
0
Denmark
Query!
State/province [37]
0
0
Kobenhavn
Query!
Country [38]
0
0
Denmark
Query!
State/province [38]
0
0
Odense
Query!
Country [39]
0
0
Denmark
Query!
State/province [39]
0
0
Roskilde
Query!
Country [40]
0
0
Estonia
Query!
State/province [40]
0
0
Tallinn
Query!
Country [41]
0
0
Estonia
Query!
State/province [41]
0
0
Tartu
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Boulogne sur Mer
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Lille Cedex
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Nouilly
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Paris
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Saint Ouen
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Saint Priest en Jarez
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Saint-Ouen
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Sainte Foy les Lyon
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Aachen
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Coburg
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Hamburg
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Hannover
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Magdeburg
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Mettmann
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Minden
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
München
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Wiesbaden
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Zwickau
Query!
Country [60]
0
0
Greece
Query!
State/province [60]
0
0
Alexandroupoli
Query!
Country [61]
0
0
Greece
Query!
State/province [61]
0
0
Athens
Query!
Country [62]
0
0
Greece
Query!
State/province [62]
0
0
Ioannina
Query!
Country [63]
0
0
Greece
Query!
State/province [63]
0
0
Larissa
Query!
Country [64]
0
0
Greece
Query!
State/province [64]
0
0
Nikaia, Piraeus
Query!
Country [65]
0
0
Greece
Query!
State/province [65]
0
0
Patra
Query!
Country [66]
0
0
Greece
Query!
State/province [66]
0
0
Thessaloniki
Query!
Country [67]
0
0
Hungary
Query!
State/province [67]
0
0
Budapest
Query!
Country [68]
0
0
Hungary
Query!
State/province [68]
0
0
Gyor
Query!
Country [69]
0
0
Hungary
Query!
State/province [69]
0
0
Kaposvar
Query!
Country [70]
0
0
Hungary
Query!
State/province [70]
0
0
Kistarcsa
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Pecs
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Szekesfehervar
Query!
Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Szigetvar
Query!
Country [74]
0
0
Hungary
Query!
State/province [74]
0
0
Zalaegerszeg
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Cagliari
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Firenze
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Genova
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Lecco
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Lucca
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Milano
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Pavia
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Pisa
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Pordenone
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
San Giovanni Rotondo FG
Query!
Country [85]
0
0
Latvia
Query!
State/province [85]
0
0
Riga
Query!
Country [86]
0
0
Latvia
Query!
State/province [86]
0
0
Valmiera
Query!
Country [87]
0
0
Lithuania
Query!
State/province [87]
0
0
Alytus
Query!
Country [88]
0
0
Lithuania
Query!
State/province [88]
0
0
Kaunas
Query!
Country [89]
0
0
Lithuania
Query!
State/province [89]
0
0
Kedainiai
Query!
Country [90]
0
0
Lithuania
Query!
State/province [90]
0
0
Klaipeda
Query!
Country [91]
0
0
Lithuania
Query!
State/province [91]
0
0
Siauliai
Query!
Country [92]
0
0
Lithuania
Query!
State/province [92]
0
0
Ukmerge
Query!
Country [93]
0
0
New Zealand
Query!
State/province [93]
0
0
Hamilton
Query!
Country [94]
0
0
New Zealand
Query!
State/province [94]
0
0
Papatoetoe, Auckland
Query!
Country [95]
0
0
New Zealand
Query!
State/province [95]
0
0
Takapuna, Auckland City
Query!
Country [96]
0
0
Poland
Query!
State/province [96]
0
0
Gdansk
Query!
Country [97]
0
0
Poland
Query!
State/province [97]
0
0
Katowice
Query!
Country [98]
0
0
Poland
Query!
State/province [98]
0
0
Poznan
Query!
Country [99]
0
0
Poland
Query!
State/province [99]
0
0
Sieradz
Query!
Country [100]
0
0
Poland
Query!
State/province [100]
0
0
Wadowice
Query!
Country [101]
0
0
Poland
Query!
State/province [101]
0
0
Warsawa
Query!
Country [102]
0
0
Poland
Query!
State/province [102]
0
0
Warszawa
Query!
Country [103]
0
0
Poland
Query!
State/province [103]
0
0
Zabrze
Query!
Country [104]
0
0
Poland
Query!
State/province [104]
0
0
Zyrardow
Query!
Country [105]
0
0
Portugal
Query!
State/province [105]
0
0
Almada
Query!
Country [106]
0
0
Portugal
Query!
State/province [106]
0
0
Aveiro
Query!
Country [107]
0
0
Portugal
Query!
State/province [107]
0
0
Estoril
Query!
Country [108]
0
0
Portugal
Query!
State/province [108]
0
0
Forte Da Casa
Query!
Country [109]
0
0
Portugal
Query!
State/province [109]
0
0
Guimarães
Query!
Country [110]
0
0
Portugal
Query!
State/province [110]
0
0
Lisboa
Query!
Country [111]
0
0
Portugal
Query!
State/province [111]
0
0
Santo Tirso
Query!
Country [112]
0
0
Portugal
Query!
State/province [112]
0
0
Setubal
Query!
Country [113]
0
0
Portugal
Query!
State/province [113]
0
0
Vila Franca de Xira
Query!
Country [114]
0
0
Russian Federation
Query!
State/province [114]
0
0
Mitishi
Query!
Country [115]
0
0
Russian Federation
Query!
State/province [115]
0
0
Moscow
Query!
Country [116]
0
0
Russian Federation
Query!
State/province [116]
0
0
Petrozavodsk
Query!
Country [117]
0
0
Russian Federation
Query!
State/province [117]
0
0
Saint Petersburg
Query!
Country [118]
0
0
Russian Federation
Query!
State/province [118]
0
0
Saint-Petersburg
Query!
Country [119]
0
0
Russian Federation
Query!
State/province [119]
0
0
Yaroslavl
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
Andalucía
Query!
Country [121]
0
0
Spain
Query!
State/province [121]
0
0
Cataluña
Query!
Country [122]
0
0
Spain
Query!
State/province [122]
0
0
Comunidad Valenciana
Query!
Country [123]
0
0
Spain
Query!
State/province [123]
0
0
Extremadura
Query!
Country [124]
0
0
Spain
Query!
State/province [124]
0
0
Navarra
Query!
Country [125]
0
0
Spain
Query!
State/province [125]
0
0
País Vasco
Query!
Country [126]
0
0
Spain
Query!
State/province [126]
0
0
Madrid
Query!
Country [127]
0
0
Sweden
Query!
State/province [127]
0
0
Malmö
Query!
Country [128]
0
0
Sweden
Query!
State/province [128]
0
0
Stockholm
Query!
Country [129]
0
0
Sweden
Query!
State/province [129]
0
0
Trollhättan
Query!
Country [130]
0
0
Switzerland
Query!
State/province [130]
0
0
Aarau
Query!
Country [131]
0
0
Switzerland
Query!
State/province [131]
0
0
Bern
Query!
Country [132]
0
0
Switzerland
Query!
State/province [132]
0
0
Geneva 14
Query!
Country [133]
0
0
Switzerland
Query!
State/province [133]
0
0
Lausanne
Query!
Country [134]
0
0
Switzerland
Query!
State/province [134]
0
0
Locarno
Query!
Country [135]
0
0
Switzerland
Query!
State/province [135]
0
0
Zurich
Query!
Country [136]
0
0
Turkey
Query!
State/province [136]
0
0
Ankara
Query!
Country [137]
0
0
Turkey
Query!
State/province [137]
0
0
Istanbul
Query!
Country [138]
0
0
Turkey
Query!
State/province [138]
0
0
Izmir
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Amgen
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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 management with hemodialysis.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01896232
Query!
Trial related presentations / 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. Stollenwerk 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. Stollenwerk 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. Wu 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. Block 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. Wolf 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
MD
Query!
Address
0
0
Amgen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01896232
Download to PDF