Pediatric Chronic Kidney Disease Safety and Efficacy

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease, Hyperparathyroidism, Hyperparathyroidism, Secondary, Kidney Disease, Secondary Hyperparathyroidism

In brief

The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.

Key facts

Study ID

NCT01277510

Run by

Amgen

People needed

43

Starts

2011-06-28

Last updated by the study team

2020-06-29

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 6 to less than 18 years at screening
• Diagnosed with CKD and SHPT receiving hemodialysis or peritoneal dialysis for ≥ 2 months before randomization
• Dry weight ≥ 12.5 kg at screening
• iPTH obtained from the central laboratory must be > 300 pg/mL (31.8 pmol/L)
• Serum calcium (corrected) obtained from the central laboratory must be ≥ 8.8 mg/dL (2.2 mmol/L)
• Serum phosphorus obtained from the central laboratory ≥ 4.0 mg/dL (1.3 mmol/L) for children 6 to less than 12 years old, or ≥ 3.5 mg/dL (1.1 mmol/L) for children 12 to less than 18 years old
• Subjects already receiving vitamin D sterols (either calcitriol or a synthetic analog), a stable dose within the last 2 months prior to randomization
• Subjects taking growth hormone, a stable dose defined as no change > than 20% in the last 2 months prior to randomization
• Subjects on anti-convulsant medication must be on a stable dose for 3 months, and have a therapeutic blood level of the anti-convulsant at the time of randomization
• Subjects must be on a dialysate calcium concentration of ≥ 2.5 mEq/L (1.25 mmol/L) for at least 2 months prior to randomization

You may not qualify if…

• Underwent parathyroidectomy in the last 6 months
• Anticipated parathyroidectomy within 6 months after randomization
• Received therapy with cinacalcet (sensipar/mimpara) within the last month
• A new onset of seizure or worsening of a pre-existing seizure disorder within the last 3 months
• Scheduled date for kidney transplant from a known living donor that makes completion of the study unlikely

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Livingston, New Jersey, United States
• Research Site — The Bronx, New York, United States
• Research Site — Greenville, North Carolina, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Portland, Oregon, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Houston, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Charlottesville, Virginia, United States
• Research Site — Randwick, New South Wales, Australia
• Research Site — Westmead, New South Wales, Australia
• Research Site — Herston, Queensland, Australia
• Research Site — Parkville, Victoria, Australia
• Research Site — Brussels, Belgium
• Research Site — Edegem, Belgium
• Research Site — Ghent, Belgium
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.