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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-22

Study Completion Date

2016-06-03

Brief Summary

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

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Detailed Description

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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).

Conditions

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Chronic Kidney Disease Hyperparathyroidism, Secondary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cinacalcet hydrochloride

Intervention Type DRUG

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.

Standard of Care

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Sensipar® Mimpara®

Eligibility Criteria

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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)

Minimum Eligible Age

28 Days

Maximum Eligible Age

2189 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No