Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02138838
• Date of registration: 01/04/2014
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
• Scientific 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
• Date of first enrolment: November 7, 2014
• Target sample size: 55
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02138838
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Czech Republic, Czechia, France, Germany, Greece, Hungary, Italy, Lithuania, New Zealand, Poland, Portugal, Russian Federation, Slovakia, Spain, Ukraine, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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)



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease, Secondary Hyperparathyroidism

Intervention(s)

Dietary Supplement: Standard of Care

Drug: Cinacalcet HCl

Primary Outcome(s)

Percentage of Participants Who Achieved a = 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15 [Time Frame: Baseline and weeks 11 to 15]

Percentage of Participants Who Achieved a = 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period [Time Frame: Baseline and the efficacy assessment period (EAP), weeks 17 to 20]

Secondary Outcome(s)

Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20 [Time Frame: Baseline and weeks 17 to 20]

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]

Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20 [Time Frame: Baseline and weeks 17 to 20]

Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20 [Time Frame: Baseline and weeks 17 to 20]

Secondary ID(s)

2013-004958-18

20130356

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/09/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02138838