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Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

Primary Purpose

Secondary Hyperparathyroidism, Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etelcalcetide
Cinacalcet
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has provided informed consent prior to performing any study-related activities/procedures.
  • Male or female subjects ≥ 18 years of age or older at the time of signing informed consent.
  • Subject must be receiving maintenance hemodialysis 3 times weekly for at least 3 months, with adequate hemodialysis based on a delivered measure of dialysis adequacy (Kt/V) ≥ 1.2 or urea reduction ratio ≥ 65% within 4 weeks prior to screening laboratory assessments. The Kt/V formula used for a subject must be the formula used during routine care prior to screening.
  • Dialysate calcium concentration must be ≥ 2.5 mEq/L (1.25 mmol/L) and stable for at least 4 weeks prior to screening laboratory assessments, and must remain ≥ 2.5 mEq/L (1.25 mmol/L) for the duration of the study.
  • Subject must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, within 2 weeks prior to randomization.
  • Subject currently receiving vitamin D sterols must have had no more than a maximum dose change of 50% within the 4 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable doses for the duration of the study, except for adjustments allowed per protocol or for safety reasons.
  • Subject must have 1 screening predialysis serum cCa laboratory value ≥ 8.3 mg/dL measured within 2 weeks prior to randomization.
  • A subject receiving calcium supplements must have had no more than a maximum dose change of 50% within 2 weeks prior to screening laboratory assessments and remain stable through randomization.
  • A subject receiving phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable dose for the duration of the study, except for adjustments allowed per protocol or for safety reasons.

Exclusion Criteria:

  • Currently receiving treatment in another investigational device or drug study, or ≤ 30 days since ending treatment on another investigational device or drug study(s). Other investigational procedures while participating in this study are excluded.
  • Subject has received etelcalcetide in a prior clinical trial of etelcalcetide.
  • Subject has received cinacalcet during the 3 months prior to the first screening laboratory assessments.
  • Subject has known sensitivity to any of the products or components of either cinacalcet or etelcalcetide to be administered during dosing.
  • Subject has previously been randomized in this study.
  • Anticipated or scheduled parathyroidectomy during the study period.
  • Subject has received a parathyroidectomy within 6 months prior to dosing.
  • Anticipated or scheduled kidney transplant during the study period.
  • Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
  • Malignancy within the last 5 years of screening (except non-melanoma skin cancers or cervical carcinoma in situ).
  • Grapefruit juice is prohibited.
  • Subject is pregnant or nursing, or planning to become pregnant or nurse during treatment or within 3 months after the last dose of etelcalcetide or 30 days after the last dose of cinacalcet
  • Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with investigational product (IP) through 3 months after the last dose of IP.
  • Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes.
  • Subject has a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
  • Subject has clinically significant abnormalities on prestudy clinical examination or abnormalities on the most recent central laboratory tests during the screening period prior to randomization according to the Investigator including but not limited to the following:

    • serum albumin < 3.0 g/dL
    • serum magnesium < 1.5 mg/dL
    • serum transaminase (alanine transaminase [ALT] or serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST] or serum glutamic oxaloacetic transaminase [SGOT]) > 3 times the upper limit of normal (ULN) at screening.
  • Subject likely not available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and Investigator's knowledge.
  • History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cinacalcet

Etelcalcetide

Arm Description

Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and the dose may have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum parathyroid hormone (PTH) ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.

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 the dose may 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.

Outcomes

Primary Outcome Measures

Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory.

Secondary Outcome Measures

Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase
Predialysis intact parathyroid hormone levels were measured by a central laboratory.
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis
Predialysis intact parathyroid hormone levels were measured by a central laboratory.
Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase
Predialysis corrected calcium was measured by a central laboratory.
Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase
Predialysis serum phosphorus was measured by a central laboratory.

Full Information

First Posted
September 15, 2017
Last Updated
April 5, 2021
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT03299244
Brief Title
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
Official Title
A Multicenter, Multiple-dose, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet Hydrochloride With Intravenous Doses of Etelcalcetide (AMG 416) in Asian Hemodialysis Subjects With Secondary Hyperparathyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by > 30% from baseline among participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants will be randomized by Interactive Voice Response (IVR)/Interactive Web Response (IWR) in a 1:1 ratio to either three times per week (TIW) intravenous (IV) etelcalcetide (and daily oral placebo tablets) or daily oral cinacalcet tablets (and TIW IV placebo) in a double-blind, double-dummy manner. Treatment groups will be blinded to the investigator, participants, and the Amgen study team.
Allocation
Randomized
Enrollment
637 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cinacalcet
Arm Type
Active Comparator
Arm Description
Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and the dose may have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum parathyroid hormone (PTH) ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
Arm Title
Etelcalcetide
Arm Type
Experimental
Arm Description
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 the dose may 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.
Intervention Type
Drug
Intervention Name(s)
Etelcalcetide
Other Intervention Name(s)
AMG 416, Parsabiv®
Intervention Description
Administered intravenously three times per week.
Intervention Type
Drug
Intervention Name(s)
Cinacalcet
Other Intervention Name(s)
Sensipar®, Mimpara®
Intervention Description
Cinacalcet administered orally once a day.
Primary Outcome Measure Information:
Title
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis
Description
Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory.
Time Frame
Baseline and the efficacy assessment phase (EAP; defined as weeks 20 to 27, inclusive).
Secondary Outcome Measure Information:
Title
Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase
Description
Predialysis intact parathyroid hormone levels were measured by a central laboratory.
Time Frame
Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive).
Title
Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis
Description
Predialysis intact parathyroid hormone levels were measured by a central laboratory.
Time Frame
Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive)
Title
Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase
Description
Predialysis corrected calcium was measured by a central laboratory.
Time Frame
Baseline and the efficacy assessment phase (weeks 20 - 27, inclusive)
Title
Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase
Description
Predialysis serum phosphorus was measured by a central laboratory.
Time Frame
Efficacy assessment phase (weeks 20 - 27, inclusive)
Other Pre-specified Outcome Measures:
Title
Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study
Description
Corrected calcium was measured by the central laboratory.
Time Frame
From first dose of study drug to end of study; up to 26 weeks + 30 days.
Title
Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study
Description
Corrected calcium was measured by the central laboratory.
Time Frame
From first dose of study drug to end of study; up to 26 weeks + 30 days.
Title
Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study
Description
Corrected calcium was measured by the central laboratory.
Time Frame
From first dose of study drug to end of study; up to 26 weeks + 30 days.
Title
Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study
Description
Common symptoms of hypocalcemia (diminished blood calcium) include paresthesias (fingertips, toes, or perioral), fatigue, muscle cramps, irritability or anxiety, tetany (eg, carpopedal spasm, laryngospasm), Chvostek's sign, seizures, and prolonged QT interval.
Time Frame
From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.
Title
Number of Participants Who Developed Antibodies to Etelcalcetide
Description
Developing antibody incidence is defined as participants who were binding antibody positive post-baseline with a negative or no result at baseline.
Time Frame
From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.
Title
Number of Participants With Treatment-emergent Adverse Events
Description
An adverse event is defined as any untoward medical occurrence in a clinical study participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. The investigator assessed whether each adverse event was possibly related to study drug. A serious adverse event is defined as an adverse event that met at least 1 of the following serious 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
Time Frame
From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has provided informed consent prior to performing any study-related activities/procedures. Male or female subjects ≥ 18 years of age or older at the time of signing informed consent. Subject must be receiving maintenance hemodialysis 3 times weekly for at least 3 months, with adequate hemodialysis based on a delivered measure of dialysis adequacy (Kt/V) ≥ 1.2 or urea reduction ratio ≥ 65% within 4 weeks prior to screening laboratory assessments. The Kt/V formula used for a subject must be the formula used during routine care prior to screening. Dialysate calcium concentration must be ≥ 2.5 mEq/L (1.25 mmol/L) and stable for at least 4 weeks prior to screening laboratory assessments, and must remain ≥ 2.5 mEq/L (1.25 mmol/L) for the duration of the study. Subject must have SHPT as defined by one central laboratory screening predialysis serum PTH value > 500 pg/mL, within 2 weeks prior to randomization. Subject currently receiving vitamin D sterols must have had no more than a maximum dose change of 50% within the 4 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable doses for the duration of the study, except for adjustments allowed per protocol or for safety reasons. Subject must have 1 screening predialysis serum cCa laboratory value ≥ 8.3 mg/dL measured within 2 weeks prior to randomization. A subject receiving calcium supplements must have had no more than a maximum dose change of 50% within 2 weeks prior to screening laboratory assessments and remain stable through randomization. A subject receiving phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable dose for the duration of the study, except for adjustments allowed per protocol or for safety reasons. Exclusion Criteria: Currently receiving treatment in another investigational device or drug study, or ≤ 30 days since ending treatment on another investigational device or drug study(s). Other investigational procedures while participating in this study are excluded. Subject has received etelcalcetide in a prior clinical trial of etelcalcetide. Subject has received cinacalcet during the 3 months prior to the first screening laboratory assessments. Subject has known sensitivity to any of the products or components of either cinacalcet or etelcalcetide to be administered during dosing. Subject has previously been randomized in this study. Anticipated or scheduled parathyroidectomy during the study period. Subject has received a parathyroidectomy within 6 months prior to dosing. Anticipated or scheduled kidney transplant during the study period. Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator. Malignancy within the last 5 years of screening (except non-melanoma skin cancers or cervical carcinoma in situ). Grapefruit juice is prohibited. Subject is pregnant or nursing, or planning to become pregnant or nurse during treatment or within 3 months after the last dose of etelcalcetide or 30 days after the last dose of cinacalcet Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during treatment with investigational product (IP) through 3 months after the last dose of IP. Subject has a history of symptomatic ventricular dysrhythmias or Torsades de Pointes. Subject has a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening. Subject has clinically significant abnormalities on prestudy clinical examination or abnormalities on the most recent central laboratory tests during the screening period prior to randomization according to the Investigator including but not limited to the following: serum albumin < 3.0 g/dL serum magnesium < 1.5 mg/dL serum transaminase (alanine transaminase [ALT] or serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST] or serum glutamic oxaloacetic transaminase [SGOT]) > 3 times the upper limit of normal (ULN) at screening. Subject likely not available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and Investigator's knowledge. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Research Site
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510150
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Research Site
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Facility Name
Research Site
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524001
Country
China
Facility Name
Research Site
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Research Site
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530022
Country
China
Facility Name
Research Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Research Site
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430034
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Research Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Research Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Research Site
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Research Site
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
Research Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Research Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
Research Site
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Facility Name
Research Site
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Facility Name
Research Site
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116027
Country
China
Facility Name
Research Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Research Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110022
Country
China
Facility Name
Research Site
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Facility Name
Research Site
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266005
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200090
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Research Site
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
Research Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
Research Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Research Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300121
Country
China
Facility Name
Research Site
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Facility Name
Research Site
City
Kowloon
Country
Hong Kong
Facility Name
Research Site
City
New Territories
Country
Hong Kong
Facility Name
Research Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 017
Country
India
Facility Name
Research Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 025
Country
India
Facility Name
Research Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 060
Country
India
Facility Name
Research Site
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110 070
Country
India
Facility Name
Research Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 006
Country
India
Facility Name
Research Site
City
Nadiad
State/Province
Gujarat
ZIP/Postal Code
387 001
Country
India
Facility Name
Research Site
City
Belagavi
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Facility Name
Research Site
City
Mysuru
State/Province
Karnataka
ZIP/Postal Code
570001
Country
India
Facility Name
Research Site
City
Kozhikode
State/Province
Kerala
ZIP/Postal Code
673 004
Country
India
Facility Name
Research Site
City
Kozhikode
State/Province
Kerala
ZIP/Postal Code
673 008
Country
India
Facility Name
Research Site
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160 012
Country
India
Facility Name
Research Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 006
Country
India
Facility Name
Research Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226 014
Country
India
Facility Name
Research Site
City
Dehradun
State/Province
Uttaranchal
ZIP/Postal Code
248 001
Country
India
Facility Name
Research Site
City
Wardha
ZIP/Postal Code
442 004
Country
India
Facility Name
Research Site
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Research Site
City
Gumi-si, Gyeongsangbuk-do
ZIP/Postal Code
730-728
Country
Korea, Republic of
Facility Name
Research Site
City
Guri-si, Gyeonggi-do
ZIP/Postal Code
471-701
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
133-817
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
150-950
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Name
Research Site
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30450
Country
Malaysia
Facility Name
Research Site
City
George Town
State/Province
Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Research Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Research Site
City
Batu Caves
State/Province
Selangor (incl. Putrajaya)
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Research Site
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Research Site
City
Keelung
ZIP/Postal Code
20401
Country
Taiwan
Facility Name
Research Site
City
New Taipei
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11031
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11101
Country
Taiwan
Facility Name
Research Site
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing 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 (or other new use) 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.
IPD Sharing 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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.
IPD Sharing URL
https://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

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