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

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01439867
First received: September 22, 2011
Last updated: April 25, 2017
Last verified: April 2017
  Purpose
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Proportion of subjects who develop corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) forages 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for ages ≥ 2 to < 6 years during the study [ Time Frame: 3.5 years ]

Secondary Outcome Measures:
  • Proportion of subjects who develop corrected serum calcium < 8.8 mg/dL (2.2 mmol/L) during the study [ Time Frame: 3.5 years ]
  • PK parameters at week 12 (eg, maximum plasma concentration (Cmax), area under the curve (AUC), apparent clearance (CL/F), apparent volume of distribution (V/F)) [ Time Frame: 3.5 years ]
  • The percent change of plasma iPTH, corrected total serum calcium, serum phosphorous, and Ca x P from baseline to scheduled visits during the study [ Time Frame: 3.5 years ]
  • Achievement of ≥ 30% reduction from baseline in plasma iPTH during the study [ Time Frame: 3.5 years ]
  • Proportion of subjects who have any normal iPTH values between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any two consecutive measurements [ Time Frame: 3.5 years ]
  • Achievement of plasma iPTH values < 300 pg/mL (31.8 pmol/L) during the study [ Time Frame: 3.5 years ]
  • Proportion of subjects who have any decreases in IPTH of ≥ 30% from baseline at two consecutive measurements [ Time Frame: 3.5 years ]

Enrollment: 18
Actual Study Start Date: June 22, 2012
Study Completion Date: June 3, 2016
Primary Completion Date: June 3, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439867

  Show 42 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01439867     History of Changes
Other Study ID Numbers: 20110100
2011-004618-40 ( EudraCT Number )
Study First Received: September 22, 2011
Last Updated: April 25, 2017

Keywords provided by Amgen:
Dialysis
Sensipar
Mimpara
Hemodialysis
Peritoneal Dialysis
Renal
Parathyroid hormone
Pediatric

Additional relevant MeSH terms:
Neoplasm Metastasis
Renal Insufficiency, Chronic
Kidney Diseases
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017