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Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01439867
Recruitment Status : Terminated (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.)
First Posted : September 23, 2011
Results First Posted : August 11, 2017
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hyperparathyroidism, Secondary Drug: Cinacalcet hydrochloride Drug: Standard of Care Phase 2

Detailed Description:

This is a multicenter, 26-week, single-arm, open-label, safety study. Participants were to remain on study for 26 weeks or until time of kidney transplantation, whichever came first.

The study and enrollment was placed on partial clinical hold in February 2013 which resulted in changes to the protocol. The study was restarted in April 2014 following these changes.

Participants who completed the 26-week study or were on study when the study was closed in June 2016 were eligible to participate in an open-label extension study (Study 20140159; NCT02341417).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis
Actual Study Start Date : June 22, 2012
Actual Primary Completion Date : June 3, 2016
Actual Study Completion Date : June 3, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Cinacalcet

Prior to the partial clinical hold, the starting dose was 0.25 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 4.2 mg/kg) based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms.

After the partial clinical hold the starting dose was 0.20 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 2.5 or 60 mg, whichever was lower) based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms.

All participants also received standard of care, which may have included vitamin D sterols.

Drug: Cinacalcet hydrochloride
Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily.
Other Names:
  • Sensipar®
  • Mimpara®

Drug: Standard of Care
Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.




Primary Outcome Measures :
  1. Percentage of Participants With Hypocalcemia [ Time Frame: 26 weeks ]
    Hypocalcemia was defined as corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to < 6 years at any time during the study.


Secondary Outcome Measures :
  1. Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study [ Time Frame: 26 weeks ]
  2. Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) [ Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 ]
  3. Percent Change From Baseline in Corrected Serum Calcium [ Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 ]
  4. Percent Change From Baseline in Serum Phosphorous [ Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 ]
  5. Percent Change From Baseline in Calcium Phosphorus Product (Ca x P) [ Time Frame: Baseline and weeks 3, 7, 11, 15, 19, 22, and 24 ]
  6. Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements [ Time Frame: 26 weeks ]
    A participant was considered to have achieved > 30% reduction in iPTH from baseline at any 2 consecutive measurements if percent change of any two consecutive post-baseline iPTH values were < -30% regardless if there was a missing value in between.

  7. Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study [ Time Frame: 26 weeks ]
    A participant was considered to have achieved ≥ 30% reduction in iPTH if the percent change of any post-baseline iPTH value was ≤ -30% from baseline.

  8. Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements [ Time Frame: 26 weeks ]
    A participant was considered to have achieved iPTH between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements if any two consecutive post-baseline iPTH values were within the range regardless if there was a missing value in between. The analysis included all enrolled subjects with at least 1 post-baseline assessment.

  9. Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study [ Time Frame: 26 weeks ]
    A participant was considered to have achieved iPTH < 300 pg/mL (31.8 pmol/L) during the study if any post-baseline iPTH value was < 300 pg/mL.

  10. Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet [ Time Frame: Week 12 ]
  11. Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet [ Time Frame: Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2189 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subjects between the ages of 28 days to < 6 years of age at enrollment (Czech Republic minimum age is ≥ 2 years of age at enrollment)
  • Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing
  • Screening corrected calcium from the central laboratory:
  • ≥ 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years
  • ≥ 8.8 (2.2 mmol/L) if age ≥ 2 to < 6 years
  • Serum phosphorus from the central laboratory:
  • ≥ 5.0 mg/dL (1.25 mmol/L) if age 28 days to < 1 year
  • ≥ 4.5 mg/dL (1.13 mmol/L) if age ≥ 1 to < 6 years
  • SHPT not due to vitamin D deficiency, per investigator assessment
  • Dry weight ≥ 7 kg at the time of screening

Exclusion criterion:

  • 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 CYP 3A4 inhibitors (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole)
  • Use of concomitant medications that may prolong the QTc interval (e.g., ondansetron, albuterol)

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): NCT01439867


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35233
United States, Arkansas
Research Site
Little Rock, Arkansas, United States, 72202
United States, California
Research Site
Los Angeles, California, United States, 90095
United States, Iowa
Research Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40202
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21287
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Research Site
Kansas City, Missouri, United States, 64108
Research Site
Saint Louis, Missouri, United States, 63110
United States, New York
Research Site
Bronx, New York, United States, 10467
United States, North Carolina
Research Site
Greenville, North Carolina, United States, 27834
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45229
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Research Site
Dallas, Texas, United States, 75390
Research Site
Houston, Texas, United States, 77030
Research Site
San Antonio, Texas, United States, 78229
Belgium
Research Site
Bruxelles, Belgium, 1020
Research Site
Gent, Belgium, 9000
Research Site
Leuven, Belgium, 3000
Czechia
Research Site
Praha 5, Czechia, 150 06
France
Research Site
Bron cedex, France, 69677
Research Site
Lille, France, 59800
Research Site
Paris, France, 75012
Research Site
Paris, France, 75015
Research Site
Paris, France, 75019
Germany
Research Site
Heidelberg, Germany, 69120
Hungary
Research Site
Budapest, Hungary, 1083
Research Site
Debrecen, Hungary, 4032
Research Site
Szeged, Hungary, 6720
Italy
Research Site
Genova, Italy, 16147
Research Site
Roma, Italy, 00165
Research Site
Torino, Italy, 10126
Mexico
Research Site
Chihuahua, Mexico, 31000
Netherlands
Research Site
Amsterdam, Netherlands, 1105 AZ
New Zealand
Research Site
Grafton, Auckland, New Zealand, 1023
Poland
Research Site
Gdansk, Poland, 80-952
Research Site
Krakow, Poland, 30-663
Research Site
Warszawa, Poland, 00-576
Russian Federation
Research Site
Moscow, Russian Federation, 107014
Research Site
Saint Petersburg, Russian Federation, 198205
Slovakia
Research Site
Kosice, Slovakia, 040 11
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
Publications:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01439867    
Other Study ID Numbers: 20110100
2011-004618-40 ( EudraCT Number )
First Posted: September 23, 2011    Key Record Dates
Results First Posted: August 11, 2017
Last Update Posted: June 17, 2020
Last Verified: June 2020
Keywords provided by Amgen:
Dialysis
Sensipar
Mimpara
Hemodialysis
Peritoneal Dialysis
Renal
Parathyroid hormone
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
Cinacalcet
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists