Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Randomized, Double Blind, Parallel Group Study For Assessing The Efficacy And Safety Of Renvela® Tablets For The Treatment Of Hyperphosphatemia In Patients With Chr
Brief Summary:
Primary Objective:
To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in hyperphosphatemia in patients with chronic kidney disease not on dialysis.
Secondary Objectives:
To document the efficacy of Renvela tablets in the reduction of serum lipids (total cholesterol and low-density lipoprotein cholesterol [LDL-C]) To document the efficacy of Renvela tablets in the reduction of calcium-phosphorus product.
To document the efficacy of Renvela tablets in the reduction of intact parathyroid hormone (iPTH).
To document the efficacy of Renvela tablets in proportion of patients reaching the target serum phosphorus level (4.6 mg/dL [1.47 mmol/L], inclusive).
To evaluate safety of Renvela tablets.