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

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02138838
First received: April 1, 2014
Last updated: June 2, 2017
Last verified: June 2017
  Purpose
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.

Condition Intervention Phase
Chronic Kidney Disease, Secondary Hyperparathyroidism Drug: Cinacalcet HCl Dietary Supplement: Standard of Care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Proportion of subjects who achieve a ≥ 30% reduction from baseline in mean plasma iPTH during Weeks 17 - 20 [ Time Frame: Week 17-20 ]
  • US only proportion of subjects who achieve a ≥ 30% reduction from baseline in mean iPTH at Weeks 11 & 15 [ Time Frame: Weeks 11&15 ]

Secondary Outcome Measures:
  • Proportion of subjects who achieve a mean iPTH ≤ 300 pg/mL (31.8 pmol/L) during weeks 17-20 [ Time Frame: Week 17-20 ]
  • Percent change in iPTH from baseline to the mean value during weeks 17-20 [ Time Frame: Week 17-20 ]
  • Change in corrected total serum calcium from baseline to the mean value during weeks 17-20 [ Time Frame: Week 17-20 ]
  • Change in serum phosphorus from baseline to the mean value during weeks 17-20 [ Time Frame: Week 17-20 ]
  • US only proportion of subjects who achieve a ≥ 30% reduction from baseline in mean iPTH during Weeks 17-20 [ Time Frame: Week 17-20 ]

Enrollment: 55
Actual Study Start Date: November 7, 2014
Study Completion Date: June 23, 2016
Primary Completion Date: June 23, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Dietary Supplement: Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Experimental: Cinacalcet
In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Drug: Cinacalcet HCl
Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets.
Other Names:
  • Sensipar®
  • Mimpara®
Dietary Supplement: Standard of Care
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

Detailed Description:

This was a 24-week, randomized, multicenter, open-label, controlled study. Participants were randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment, or standard of care alone. Randomization was stratified by age group (6 to < 12 and 12 to < 18 years of age). All participants received standard of care which could include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders.

Participants in both treatment groups who completed the 20-week treatment period and those who ended the study due to study closure were eligible to enroll in an open-label extension study (20140159; NCT02341417) for further safety follow-up.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  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: NCT02138838

  Show 60 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02138838     History of Changes
Other Study ID Numbers: 20130356
2013-004958-18 ( EudraCT Number )
Study First Received: April 1, 2014
Last Updated: June 2, 2017

Keywords provided by Amgen:
Chronic Kidney Disease, Secondary Hyperparathyroidism, Dialysis, Pediatric

Additional relevant MeSH terms:
Kidney Diseases
Neoplasm Metastasis
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
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 June 27, 2017