Protocol 20120229 - AMG 416 in Chronic Kidney Disease

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

• IRAS ID

  121012

• Contact name

  Nicholas Pritchard

• Sponsor organisation

  Amgen Inc

• Eudract number

  2012-002805-23

• Research summary

  The purpose of this clinical study is to see whether a new trial drug called AMG 416 is effective in treating people with secondary hyperparathyroidism (SHPT) with chronic kidney disease who are on haemodialysis. To evaluate the effectiveness of AMG 416, it will be compared to a placebo (an inactive dummy drug) for reducing the blood levels of serum intact parathyroid hormone (iPTH) by more than 30%. The study will also see whether AMG 416 causes side effects in comparison with the placebo and will look at what doses of AMG 416 are safe and effective. AMG 416 is being developed as a treatment to reduce iPTH levels in blood caused by SHPT. High levels of 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. In this study, patients will be randomly assigned (like flipping a coin) to treatment with either AMG 416 or placebo (there will be an equal chance of being assigned to either AMG 416 or placebo). The study treatment (AMG 416 or placebo) will be administered three times a week at the end of each hemodialysis treatment. All participants, regardless of treatment assignment, will also receive standard of care for their SHPT, as prescribed by the study Investigator. This is a double-blind study meaning that neither the participants nor the investigators will know which treatment the participant has been assigned to. The starting dose of AMG 416 will be 5mg and may be increased up to 15mg depending on a participant's levels of iPTH. There will be a screening period (period for assessing the participant's suitability) lasting up to 8 weeks, followed by a 26 week treatment period and then a 4 week follow-up period after the last treatment dose.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  13/LO/0072

• Date of REC Opinion

  18 Mar 2013

• REC opinion

  Further Information Favourable Opinion