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

NCT02138838 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: 201303562013-004958-18
• Study Type: interventional
• Target: 55
• Locations: 16 countries
• Sites: 60

Brief Summary

The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.

Conditions

Chronic Kidney Disease, Secondary Hyperparathyroidism

Keywords

Chronic Kidney Disease, Secondary Hyperparathyroidism, Dialysis, Pediatric

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15

  Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated. This endpoint was the primary endpoint in the US only.

  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

  Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated. This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint.

  Baseline and the efficacy assessment period (EAP), weeks 17 to 20

Secondary Outcomes (4)

• Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20

  Efficacy assessment period, weeks 17 to 20

• Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20

  Baseline and weeks 17 to 20

• Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20

  Baseline and weeks 17 to 20

• Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20

  Baseline and weeks 17 to 20

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

Dietary Supplement: Standard of Care

Cinacalcet

EXPERIMENTAL

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; Dietary Supplement: Standard of Care

Interventions

Cinacalcet HCl DRUG

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.

Also known as: Sensipar®, Mimpara®

Cinacalcet

Standard of Care DIETARY_SUPPLEMENT

Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.

Cinacalcet; Standard of Care

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amgen: lead

Study Sites (60)

Research Site

Los Angeles, California, 90027, United States

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Wilmington, Delaware, 19803, United States

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Atlanta, Georgia, 30322, United States

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Chicago, Illinois, 60612, United States

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Iowa City, Iowa, 52242, United States

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Louisville, Kentucky, 40202, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02115, United States

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Detroit, Michigan, 48201, United States

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Minneapolis, Minnesota, 55454, United States

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Jackson, Mississippi, 39216, United States

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Kansas City, Missouri, 64108, United States

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St Louis, Missouri, 63104, United States

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St Louis, Missouri, 63110, United States

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West Orange, New Jersey, 07052, United States

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New York, New York, 10029, United States

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The Bronx, New York, 10467, United States

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Greenville, North Carolina, 27834, United States

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Cincinnati, Ohio, 45229, United States

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Cleveland, Ohio, 44106, United States

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Columbus, Ohio, 43205, United States

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Philadelphia, Pennsylvania, 19104, United States

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Dallas, Texas, 75235, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84113, United States

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Brussels, 1020, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Prague, 150 06, Czechia

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Bron, 69677, France

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Lille, 59800, France

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Marseille, 13385, France

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Nice, 06202, France

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Paris, 75012, France

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Paris, 75015, France

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Paris, 75019, France

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Marburg, 35043, Germany

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Athens, 11527, Greece

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Thessaloniki, 54642, Greece

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Budapest, 1083, Hungary

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Szeged, 6720, Hungary

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Genova, 16147, Italy

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Napoli, 80129, Italy

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Torino, 10126, Italy

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Vilinus, 08406, Lithuania

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Grafton, Auckland, 1023, New Zealand

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Krakow, 30-663, Poland

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Lodz, 93-338, Poland

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Warsaw, 00-576, Poland

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Porto, 4050 371, Portugal

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Moscow, 107014, Russia

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Saint Petersburg, 198205, Russia

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Samara, 443095, Russia

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Košice, 040 11, Slovakia

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Barcelona, Catalonia, 08035, Spain

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Espluques de LLobregat, Catalonia, 08950, Spain

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Kyiv, 01135, Ukraine

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Related Publications (2)

• Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.

  PMID: 30756425 BACKGROUND

• Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.

  PMID: 32367309 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary

Interventions

Cinacalcet; Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: May 15, 2014
• Study Start: November 7, 2014
• Primary Completion: June 23, 2016
• Study Completion: June 23, 2016
• Last Updated: June 29, 2020
• Results First Posted: September 14, 2017

Record last verified: 2020-06

Locations

PT (1); DE (3); UA (1); RU (3); ES (2); PL (3); IT (3); LI (1); GR (2); US (26); HU (2); CZ (1); SL (1); BE (3); FR (7); NZ (1)