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Study of Etelcalceide in Pediatric Subjects With Secondary Hyperparathyroidism and CKD on Hemodialysis

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ClinicalTrials.gov Identifier: NCT03633708
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Chronic Kidney Disease Drug: Etelcalcetide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Open-label, Controlled, Multiple Dose, Efficacy, Safety, PK, and PD Study of Etelcalcetide in Pediatric Subjects 28 Days to < 18 YOA With Secondary Hyperparathyroidism and CKD Receiving Maintenance Hemodialysis
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Etelcalcetide
Randomized in a 3:1 ratio to receive etelcalcetide in addition to standard of care
Drug: Etelcalcetide
Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling intact parathyroid hormone (iPTH), Ca, and phosphorus and has recently been approved for use in adult patients with SHPT treated with hemodialysis in both the United States and Europe

Active Comparator: Control
Randomized in a 3:1 ratio to receive etelcalcetide in addition standard of care alone (control arm)
Drug: Etelcalcetide
Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling intact parathyroid hormone (iPTH), Ca, and phosphorus and has recently been approved for use in adult patients with SHPT treated with hemodialysis in both the United States and Europe




Primary Outcome Measures :
  1. Change of intact parathyroid hormone (iPTH) levels in children ages 28d to <18y with secondary hyperparathyroidism (sHPT) receiving maintenance hemodialysis [ Time Frame: 32 weeks ]
    Achievement of at least a 30% reduction from baseline in mean iPTH during the efficacy assessment phase (EAP)


Secondary Outcome Measures :
  1. Corrected serum calcium levels of < 8.0 mg/dL in children aged 2 years to <18 years old [ Time Frame: 32 weeks ]
  2. Corrected serum calcium levels of < 8.6 mg/dL in children aged 28 days to <18 years old [ Time Frame: 32 weeks ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Dry weight ≥ 7 kg during screening.
  • Diagnosed with CKD and SHPT undergoing hemodialysis at the time of screening.
  • Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values ≥ 400 pg/mL (42 pmol/L) during screening, on separate days and within 2 weeks of enrolment.
  • Serum cCa value ≥ 9.0 mg/dL (2.25 mmol/L) for subjects ≥ 2 years of age and older and serum cCa value ≥ 9.6 mg/dL (2.4 mmol/L) for subjects 28 days to < 2 years of age obtained from the central laboratory during screening.
  • Dialysate Ca level ≥ 2.5 mEq/L during screening.
  • SHPT not due to vitamin D deficiency, per investigator assessment.

Exclusion

  • Anticipated or scheduled parathyroidectomy or kidney transplant during the study period.
  • Subject has received a parathyroidectomy within 6 months prior to randomization.
  • Receipt of cinacalcet therapy within 30 days prior to screening assessments and through randomization.
  • Receipt of etelcalcetide within 6 months prior to screening assessments and through randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633708


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, Missouri
Research Site Recruiting
Kansas City, Missouri, United States, 64108
United States, New York
Research Site Recruiting
New York, New York, United States, 10029
United States, Ohio
Research Site Recruiting
Cincinnati, Ohio, United States, 45229
Research Site Recruiting
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Research Site Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Utah
Research Site Recruiting
Salt Lake City, Utah, United States, 84113
Argentina
Research Site Recruiting
San Miguel de Tucuman, Tucuman, Argentina, 4000
Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of, 110-744
Research Site Recruiting
Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 50612
Malaysia
Research Site Recruiting
Kota Bharu, Kelantan, Malaysia, 15586
Research Site Recruiting
Seremban, Negri Sembilan, Malaysia, 70300
Research Site Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50300
Russian Federation
Research Site Recruiting
Moscow, Russian Federation, 107014
Research Site Recruiting
Saint Petersburg, Russian Federation, 198205
Research Site Recruiting
Samara, Russian Federation, 443095
Singapore
Research Site Recruiting
Singapore, Singapore, 119074
Taiwan
Research Site Recruiting
Kaohsiung, Taiwan, 81362
Research Site Recruiting
Taipei, Taiwan, 10041
Research Site Recruiting
Taoyuan, Taiwan, 33305
Turkey
Research Site Recruiting
Ankara, Turkey, 06230
Research Site Recruiting
Ankara, Turkey, 06490
Research Site Recruiting
Ankara, Turkey, 06500
Research Site Recruiting
Istanbul, Turkey, 34098
Research Site Recruiting
Izmir, Turkey, 35040
Research Site Recruiting
Kayseri, Turkey, 38039
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03633708     History of Changes
Other Study ID Numbers: 20140315
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
sHPT
CKD
pediatric
Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases