DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease; Hyperparathyroidism, Secondary

Intervention: Cinacalcet HCl (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Overall contact:
Amgen Call Center, Phone: 866-572-6436

Summary

This is a multicenter, 26-week, single-arm, open-label, safety study. Subjects will remain on study for 26 weeks or until time of kidney transplantation, whichever comes first. All subjects, in addition to receiving cinacalcet, will receive standard of care, which may include vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs).

Clinical Details

Official title: An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Occurrence of corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) forages 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for ages ≥ 2 to < 6 years during the study

Secondary outcome:

Occurrence of corrected serum calcium < 8.8 mg/dL (2.2 mmol/L) during the study

PK parameters at week 12 (eg, maximum plasma concentration (Cmax), area under the curve (AUC), apparent clearance (CL/F), apparent volume of distribution (V/F))

The percent change of plasma iPTH, corrected total serum calcium, serum phosphorous, and Ca x P from baseline to scheduled visits during the study

Achievement of ≥ 30% reduction from baseline in plasma iPTH during the study

Achievement of plasma iPTH values between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any two consecutive measurements

Achievement of plasma iPTH values < 300 pg/mL (31.8 pmol/L) during the study

Eligibility

Minimum age: N/A. Maximum age: 2189 Days. Gender(s): Both.

Criteria:

Inclusion criteria:

- 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 total serum 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

Exclusion criterion:

- 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)

Locations and Contacts

Amgen Call Center, Phone: 866-572-6436

Research Site, Bruxelles 1020, Belgium; Recruiting

Research Site, Gent 9000, Belgium; Recruiting

Research Site, Leuven 3000, Belgium; Recruiting

Research Site, Praha 5 150 06, Czech Republic; Recruiting

Research Site, Bron cedex 69677, France; Recruiting

Research Site, Heidelberg 69120, Germany; Completed

Research Site, Budapest 1083, Hungary; Recruiting

Research Site, Debrecen 4032, Hungary; Completed

Research Site, Szeged 6720, Hungary; Recruiting

Research Site, Genova 16147, Italy; Recruiting

Research Site, Torino 10126, Italy; Recruiting

Research Site, Chihuahua 31000, Mexico; Completed

Research Site, Amsterdam 1105 AZ, Netherlands; Completed

Research Site, Grafton, Auckland 1023, New Zealand; Recruiting

Research Site, Gdansk 80-952, Poland; Recruiting

Research Site, Krakow 30-663, Poland; Recruiting

Research Site, Warszawa 00-576, Poland; Recruiting

Research Site, Moscow 107014, Russian Federation; Recruiting

Research Site, Saint Petersburg 198205, Russian Federation; Recruiting

Research Site, Kosice 040 11, Slovakia; Recruiting

Research Site, Birmingham, Alabama 35233, United States; Completed

Research Site, Little Rock, Arkansas 72202, United States; Completed

Research Site, Los Angeles, California 90095, United States; Recruiting

Research Site, Iowa City, Iowa 52242, United States; Recruiting

Research Site, Louisville, Kentucky 40202, United States; Recruiting

Research Site, Baltimore, Maryland 21287, United States; Recruiting

Research Site, Kansas City, Missouri 64108, United States; Recruiting

Research Site, St Louis, Missouri 63110, United States; Recruiting

Research Site, Greenville, North Carolina 27834, United States; Completed

Research Site, Cincinnati, Ohio 45229, United States; Recruiting

Research Site, Oklahoma City, Oklahoma 73104, United States; Recruiting

Research Site, Philadelphia, Pennsylvania 19104, United States; Recruiting

Research Site, Houston, Texas 77030, United States; Recruiting

Research Site, San Antonio, Texas 78229, United States; Recruiting

Additional Information

AmgenTrials clinical trials website

Starting date: June 2012
Last updated: August 19, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017