20070360 Phase 4 Study of Cinacalcet in the Treatment of Secondary HPT

• Research type

  Research Study

• Full title

  Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

• IRAS ID

  7878

• Sponsor organisation

  Amgen Limited

• Eudract number

  2008-004558-34

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Secondary hyperparathyroidism (HPT) is common in people with chronic kidney disease (CKD). Patients with secondary HPT often have high levels of a hormone called parathyroid hormone (PTH), and abnormal levels of calcium and phosphorus in the blood. A problem for patients with secondary HPT is bone disease which can cause pain and lead to fractures. The purpose of this study is to examine the effects of cinacalcet on levels of PTH in the blood in patients who have recently started hemodialysis.Cinacalcet acts directly on the calcium-sensing receptors on the surface of the parathyroid gland cells to increase the parathyroid glands sensitivity to calcium and thus lower PTH levels. This study will include a total of approximately 300 subjects from approximately 100 dialysis centers across Europe, Russia, North America and Australia. Patients will be randomly selected (like flipping a coin) to be in one of 2 treatment groups at a 1:1 ratio. One hundred and fifty of the 300 people enrolled in this study will be in the 'control group??. The 'control group' will continue to receive their current therapy (eg, active vitamin D sterols and phosphate binders, if prescribed). The other 150 (150 of 300) people will be in the cinacalcet treatment group and will receive the test drug. The patients selected to be in the cinacalcet treatment group may have their current vitamin D treatment changed to a lower dose.The study will consist of a screening period (to determine whether it is appropriate for each patient to participate in the study) lasting up to 14 days, a 4-week washout of vitamin D (if the patient has been receiving this drug), a 52-week treatment period and finally, a 4-week washout of vitamin D and cinacalcet. If patients complete this study, their time in the study will be about 60 weeks (1 year and 2 months). Blood will be collected at most of the study visits to measure PTH, calcium, albumin, and phosphorus.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  08/H0305/72

• Date of REC Opinion

  15 Dec 2008

• REC opinion

  Further Information Favourable Opinion