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A Study to Assess the Efficacy and Safety of Cinacalcet in Pediatric Subjects With SHPT and CKD on Dialysis

This study has been terminated.
(Decision made 17Feb16 to early terminate to provide full CSR for Nov16 US filing for pediatric indication.)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02138838
First received: April 1, 2014
Last updated: July 4, 2016
Last verified: June 2016
  Purpose
This is a phase 3, 24-week, randomized, multicenter, open-label, controlled study. subjects will be randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment arm or a standard of care arm. Randomization will be stratified by age group. All subjects receive standard of care which can include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders.

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]
  • US only proportion of subjects who achieve a ≥ 30% reduction from baseline in mean iPTH at Weeks 11 & 15 [ Time Frame: Weeks 11&15 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • Percent change in iPTH from baseline to the mean value during weeks 17-20 [ Time Frame: Week 17-20 ] [ Designated as safety issue: Yes ]
  • Change in corrected total serum calcium from baseline to the mean value during weeks 17-20 [ Time Frame: Week 17-20 ] [ Designated as safety issue: Yes ]
  • Change in serum phosphorus from baseline to the mean value during weeks 17-20 [ Time Frame: Week 17-20 ] [ Designated as safety issue: Yes ]
  • US only proportion of subjects who achieve a ≥ 30% reduction from baseline in mean iPTH during Weeks 17-20 [ Time Frame: Week 17-20 ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: November 2014
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cinacalcet HCl
50% of subjects will receive cinacalcet in addition to standard of care, which can include vitamin D sterols, calcium supplements or phosphate binders
Drug: Cinacalcet HCl
Subjects will receive oral administration of cinacalcet daily in addition to standard of care therapy. Cinacalcet will be provided in 5 mg capsules that must be sprinkled onto soft food or suspended into a liquid suspension for administration and 30 mg tablets for swallowing. The protocol specified doses for use in this study are: 2.5, 5, 10, 15, 30, 60, 90, 120, and 180 mg (the lowest dose available in Spain, Germany, Greece, and Portugal is 5 mg). The maximum dose of cinacalcet that will be administered at any time during the study will be 2.5 mg/kg/day based on the subject's dry weight during randomization or 180 mg daily, whichever is lower. The treatment period consists of Weeks 1 - 20. Following completion of the treatment period, all subjects will enter a 4 week safety follow-up period through Week 24.
Active Comparator: Standard of Care
50% of subjects will receive standard of care, which can include vitamin D sterols, calcium supplements or phosphate binders.
Dietary Supplement: Standard of Care
At the investigator's discretion, subjects will receive standard of care, which can include vitamin D sterols, calcium supplements or phosphate binders. The treatment period consists of Weeks 1 - 20. Following completion of the treatment period, all subjects will enter a 4 week safety follow-up period through Week 24.
Other Names:
  • Vitamin D sterols (e.g. calcitriol, paricalcitol), calcium supplementation and phosphate
  • binders (calcium based and non-calcium based).

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
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 CYP 3A4 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 
Study First Received: April 1, 2014
Last Updated: July 4, 2016
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
France: The French National Agency for Medicines and Health Products Safety
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Mexico: Ministry of Health
New Zealand: Medsafe

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
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Cinacalcet Hydrochloride
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 23, 2016