Safety of BPS804 in patients with late-stage chronic kidney disease

• Research type

  Research Study

• Full title

  A randomized, placebo-controlled trial of BPS804 on safety and tolerability in patients with late-stage chronic kidney disease

• IRAS ID

  116031

• Contact name

  David Goldsmith

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2012-003348-63

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Patients with chronic kidney disease (CKD) have an increased risk of fracture, and are at least twice as likely as those in the general population to break a bone. There is an increasing need for new treatments to improve bone turnover (the rate at which bone is broken down and rebuilt) in patients with CKD, because current therapies may not be safe to use in patients with impaired kidney function. It is also not possible to use the results from studies on postmenopausal women with osteoporosis due to the cause of the bone disease being different in patients with CKD. Approximately half of all patients with CKD have adynamic bone disease (ABD), which is associated with very low bone turnover, reduced activity by both the osteoblasts (bone building cells) and the osteoclasts (bone resorbing cells), and an increased risk of fracture.Sclerostin is a protein, a natural substance secreted during bone turnover, which has a negative effect on the osteoblast (bone-building cells) and causes a reduction in bone formation. BPS804 is an anti-sclerostin antibody (plasma protein) which stops sclerostin working, therefore allowing bone formation to increase. BPS804 has recently been developed and to date the safety and tolerability of BPS804 has been tested in 4 clinical studies with approximately 70 men and women, and these studies have shown that BPS804 was well tolerated and bone formation and bone mineral density were significantly increased. The primary purpose of this study is to evaluate the safety, pharmacokinetics and tolerability of BPS804 in patients with CKD stage 5 who are on dialysis. An important exploratory objective is to evaluate the effect of BPS804 on bone formation using the radioactive tracer technique 18F-fluoride positron emission tomography (18F-PET).

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/1908

• Date of REC Opinion

  9 Feb 2013

• REC opinion

  Further Information Favourable Opinion