Effects of Phosphate Binding in Stage 3 Chronic Kidney Disease

• Research type

  Research Study

• Full title

  Does Phosphate Binding With Sevelamer Carbonate Improve Cardiovascular Structure and Function in Patients with Early Chronic Kidney Disease?

• Contact name

  Charles J Ferro

• Sponsor organisation

  University Hospital Birmingham NHS Foundation Trust

• Eudract number

  2008-003727-23

• ISRCTN Number

  N/A

• Research summary

  High levels of phosphate in the blood can lead to the early development of hardening of the blood vessels. Patients with kidney disease have higher levels of phosphate compared to healthy people, increasing their risk of early hardening of the blood vessels and early heart disease and stroke. A drug called sevelamer effectively lowers phosphate levels in patients with severe kidney disease. As a result, such patients receiving sevelamer have less hardening of the blood vessels. We hope to prove that by lowering the phosphate level in patients with early kidney disease, sevelamer could slow the development of hardening of the blood vessels and subsequently prevent excessive heart muscle growth and impaired heart function. Beneficial effects on the arteries and hearts of patients with early stage kidney disease would provide powerful evidence that the risks of heart disease and stroke might be reduced by sevelamer in this large high-risk population. We will perform an investigator-led, randomised, double-blinded, placebo-controlled trial to study the effects of sevelamer on cardiovascular structure and function in patients with stage 3 chronic kidney disease. Baseline measurements will be performed, including a 12-lead electrocardiogram (heart tracing), blood tests, urine collection, transthoracic echocardiogram (heart scan), cardiac magnetic resonance scan and applanation tonography (using a pressure probe on the wrist and groin) to measure arterial wave forms. Subjects will then be randomised to receive 1600mg of sevelamer three times daily or placebo. Following the 36-week treatment period, these measurements will be repeated. We will look for differences between the two groups after treatment to determine the effects of sevelamer in reducing hardening of the arteries. The study is funded by an unrestricted educational grant from Genzyme Therapeutics Limited. Recruitment will be from the kidney outpatient clinic at University Hospital Birmingham NHS Foundation Trust.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  08/H1208/37

• Date of REC Opinion

  1 Oct 2008

• REC opinion

  Further Information Favourable Opinion