Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

NCT01439867 | Terminated Phase 2 Results

• 2 other identifiers: 201101002011-004618-40
• Study Type: interventional
• Target: 18
• Locations: 13 countries
• Sites: 42

Brief Summary

The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

Conditions

Chronic Kidney Disease; Hyperparathyroidism, Secondary

Keywords

Dialysis; Sensipar; Mimpara; Hemodialysis; Peritoneal Dialysis; Renal; Parathyroid hormone; Pediatric

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Hypocalcemia

  Hypocalcemia was defined as corrected serum calcium levels \< 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to \< 2 years, and \< 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to \< 6 years at any time during the study.

  26 weeks

Secondary Outcomes (11)

• Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study

  26 weeks

• Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)

  Baseline and weeks 3, 7, 11, 15, 19, 22, and 24

• Percent Change From Baseline in Corrected Serum Calcium

  Baseline and weeks 3, 7, 11, 15, 19, 22, and 24

• Percent Change From Baseline in Serum Phosphorous

  Baseline and weeks 3, 7, 11, 15, 19, 22, and 24

• Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)

  Baseline and weeks 3, 7, 11, 15, 19, 22, and 24

Study Arms (1)

Cinacalcet

EXPERIMENTAL

Prior to the partial clinical hold, the starting dose was 0.25 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 4.2 mg/kg) based on plasma intact parathyroid hormone (iPTH), corrected serum calcium levels obtained monthly, and adverse signs and symptoms. After the partial clinical hold the starting dose was 0.20 mg/kg (based on dry weight) and was titrated upwards (maximum allowed daily dose of 2.5 or 60 mg, whichever was lower) based on plasma iPTH, corrected serum calcium levels obtained monthly, weekly monitoring of ionized calcium levels, and adverse signs and symptoms. All participants also received standard of care, which may have included vitamin D sterols.

Drug: Cinacalcet hydrochloride; Drug: Standard of Care

Interventions

Cinacalcet hydrochloride DRUG

Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily.

Also known as: Sensipar®, Mimpara®

Cinacalcet

Standard of Care DRUG

Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.

Cinacalcet

Eligibility Criteria

• Age: 28 Days - 2189 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects between the ages of 28 days to \< 6 years of age at enrollment (Czech Republic minimum age is ≥ 2 years of age at enrollment)
• Screening plasma iPTH level \> 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing
• Screening corrected calcium from the central laboratory:
• ≥ 9.4 mg/dL (2.35 mmol/L) if age 28 days to \< 2 years
• ≥ 8.8 (2.2 mmol/L) if age ≥ 2 to \< 6 years
• Serum phosphorus from the central laboratory:
• ≥ 5.0 mg/dL (1.25 mmol/L) if age 28 days to \< 1 year
• ≥ 4.5 mg/dL (1.13 mmol/L) if age ≥ 1 to \< 6 years
• SHPT not due to vitamin D deficiency, per investigator assessment
• Dry weight ≥ 7 kg at the time of screening
• 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 (e.g., erythromycin, clarithromycin, ketoconazole, itraconazole)
• Use of concomitant medications that may prolong the QTc interval (e.g., ondansetron, albuterol)

Sponsors & Collaborators

• Amgen: lead

Study Sites (42)

Research Site

Birmingham, Alabama, 35233, United States

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Little Rock, Arkansas, 72202, United States

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Los Angeles, California, 90095, 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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Ann Arbor, Michigan, 48109, United States

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Kansas City, Missouri, 64108, United States

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St Louis, Missouri, 63110, 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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Oklahoma City, Oklahoma, 73104, United States

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Philadelphia, Pennsylvania, 19104, United States

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Dallas, Texas, 75390, 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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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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Paris, 75012, France

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Paris, 75015, France

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Paris, 75019, France

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Heidelberg, 69120, Germany

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Budapest, 1083, Hungary

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Debrecen, 4032, Hungary

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Szeged, 6720, Hungary

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Genova, 16147, Italy

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Roma, 00165, Italy

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Torino, 10126, Italy

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Chihuahua City, 31000, Mexico

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Amsterdam, 1105 AZ, Netherlands

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Grafton, Auckland, 1023, New Zealand

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Gdansk, 80-952, Poland

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Krakow, 30-663, Poland

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Warsaw, 00-576, Poland

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Moscow, 107014, Russia

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Saint Petersburg, 198205, Russia

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Košice, 040 11, Slovakia

Location

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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 23, 2011
• Study Start: June 22, 2012
• Primary Completion: June 3, 2016
• Study Completion: June 3, 2016
• Last Updated: June 17, 2020
• Results First Posted: August 11, 2017

Record last verified: 2020-06

Locations

HU (3); FR (5); ME (1); NZ (1); PL (3); SL (1); CZ (1); RU (2); US (17); IT (3); BE (3); DE (1); NL (1)