Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Kidney Diseases

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Bone Density Conservation Agents

Cinacalcet

Hormones

Calcium

Calcium, Dietary

Hormone Antagonists

Participants received a single, oral dose of 0.25 mg/kg cinacalcet.

Single, oral dose of 0.25 mg/kg cinacalcet

The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.

Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease

An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cinacalcet HCl in Pediatric Subjects Aged 28 Days to Less Than 6 Years With Chronic Kidney Disease Receiving Dialysis

A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.

The terminal half-life (T1/2) of cinacalcet associated with the slope of the terminal phase.

Amgen

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.

Cinacalcet 0.25 mg/kg

Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

American Indian or Alaska Native

Asian

Black (or African American)

Native Hawaiian or Other Pacific Islander

White

Other

Race/Ethnicity, Customized

Study Director

Any adverse event (AE)

Serious adverse events

AE leading to discontinuation of study drug

Fatal adverse events

Treatment-related adverse events

Adverse events of interest

All participants who received at least 1 dose of cinacalcet.

Number of Participants With Adverse Events

Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet

Pharmacokinetics analysis set; The AUCinf value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.

Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet

Maximum Observed Plasma Concentration (Cmax) of Cinacalcet

Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax)

Pharmacokinetics analysis set; The T1/2 value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.

Terminal Half-life of Cinacalcet

2 hours post-dose (n = 9)

8 hours post-dose (n = 5)

12 hours post-dose (n = 5)

48 hours post-dose (n = 9)

Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. "n" indicates participants with non-missing data at the time point of interest.

Spots Global Cancer Trial Database for Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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