Protocol 20120231 - Extension Study -AMG 416 in Chronic Kidney Disease

• Research type

  Research Study

• Full title

  A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

• IRAS ID

  121015

• Contact name

  Nicholas Pritchard

• Sponsor organisation

  Amgen Ink

• Eudract number

  2012-002808-41

• Research summary

  This study is the extension study to the 20120229 study. The purpose of this extension study is to look at the long term effectiveness and safety of the new trial drug, AMG 416, for the treatment of secondary hyperparathyroidism (SHPT) in people with chronic kidney disease who are on haemodialysis.AMG 416 is being developed as a treatment to reduce iPTH levels in blood caused by SHPT. High blood serum levels of intact parathyroid hormone (iPTH) can affect the calcium and phosphorus levels in the body and is linked to complications such as bone disease and heart and blood vessel disease.Eligible participants must start treatment with AMG 416 on the last day of the 30 day follow-up visit in the 20120229 study. In this extension study, all participants will receive AMG 416 (there is no placebo [inactive dummy drug] as with the 20120229 study) for a total of 52 weeks. AMG 416 will be administered 3 times a week at the end of each hemodialysis treatment. The starting dose will be 5mg and may be increased up to 15mg depending on a participant's levels of iPTH. At the end of the 52 week treatment period, there will be a 30 days follow-up period.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  13/LO/0073

• Date of REC Opinion

  28 Mar 2013

• REC opinion

  Further Information Favourable Opinion