Back to resultsEfficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
Primary Purpose
Chronic Kidney Disease, Secondary Hyperparathyroidism
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cinacalcet HCl
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease, Secondary Hyperparathyroidism focused on measuring Chronic Kidney Disease, Secondary Hyperparathyroidism, Dialysis, Pediatric
Eligibility Criteria
Inclusion Criteria:
- Age 6 - < 18 years
- Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values ≥ 300 pg/mL during screening
- Corrected calcium value of ≥ 8.8 mg/dL during screening
- Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days prior to screening
- Parent or legally acceptable representative has provided written informed consent and subject has provided written assent when required by institutional guidelines
Exclusion Criteria:
- History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
- Corrected QT interval (QTc) > 500 ms, using Bazett's formula
- QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
- Use of grapefruit juice, herbal medications, or potent cytochrome P450 3A4 (CYP3A4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
- Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care
Cinacalcet
Arm Description
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15
Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated.
This endpoint was the primary endpoint in the US only.
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period
Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated.
This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint.
Secondary Outcome Measures
Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20
Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20
Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20
Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02138838
Brief Title
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
Official Title
A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Amgen decided to terminate the study early to be able to meet US regulatory timelines fo filing. Subjects in treatment were rolled over to the 20140159 study.
Study Start Date
November 7, 2014 (Actual)
Primary Completion Date
June 23, 2016 (Actual)
Study Completion Date
June 23, 2016 (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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
Detailed Description
This was a 24-week, randomized, multicenter, open-label, controlled study. Participants were randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment, or standard of care alone. Randomization was stratified by age group (6 to < 12 and 12 to < 18 years of age). All participants received standard of care which could include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders.
Participants in both treatment groups who completed the 20-week treatment period and those who ended the study due to study closure were eligible to enroll in an open-label extension study (20140159; NCT02341417) for further safety follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Secondary Hyperparathyroidism
Keywords
Chronic Kidney Disease, Secondary Hyperparathyroidism, Dialysis, Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Arm Title
Cinacalcet
Arm Type
Experimental
Arm Description
In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Intervention Type
Drug
Intervention Name(s)
Cinacalcet HCl
Other Intervention Name(s)
Sensipar®, Mimpara®
Intervention Description
Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15
Description
Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated.
This endpoint was the primary endpoint in the US only.
Time Frame
Baseline and weeks 11 to 15
Title
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period
Description
Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated.
This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint.
Time Frame
Baseline and the efficacy assessment period (EAP), weeks 17 to 20
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20
Time Frame
Efficacy assessment period, weeks 17 to 20
Title
Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20
Time Frame
Baseline and weeks 17 to 20
Title
Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20
Time Frame
Baseline and weeks 17 to 20
Title
Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20
Time Frame
Baseline and weeks 17 to 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 6 - < 18 years
Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values ≥ 300 pg/mL during screening
Corrected calcium value of ≥ 8.8 mg/dL during screening
Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days prior to screening
Parent or legally acceptable representative has provided written informed consent and subject has provided written assent when required by institutional guidelines
Exclusion Criteria:
History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
Corrected QT interval (QTc) > 500 ms, using Bazett's formula
QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
Use of grapefruit juice, herbal medications, or potent cytochrome P450 3A4 (CYP3A4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
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
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Research Site
City
Bron cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Research Site
City
Lille
ZIP/Postal Code
59800
Country
France
Facility Name
Research Site
City
Marseille cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Research Site
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Research Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16147
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80129
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Vilinus
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
Research Site
City
Grafton, Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
00-576
Country
Poland
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4050 371
Country
Portugal
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
107014
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Research Site
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Espluques De LLobregat
State/Province
Cataluña
ZIP/Postal Code
08950
Country
Spain
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
01135
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
30756425
Citation
Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.
Results Reference
background
PubMed Identifier
32367309
Citation
Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
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