Clinical Trial: Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China

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.


Detailed Summary: The total duration of study period per patient will be up to 14 weeks.
Sponsor: Sanofi

Current Primary Outcome: Change from baseline in serum phosphorus level [ Time Frame: at Week 8 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in total cholesterol [ Time Frame: at Week 8 ]
  • Change from baseline in LDL-C [ Time Frame: at Week 8 ]
  • Change from baseline in calcium-phosphorus product [ Time Frame: at Week 8 ]
  • Change from baseline in intact parathyroid hormone (iPTH) level [ Time Frame: at Week 8 ]
  • Percentage of patients reaching the target serum phosphorus level (4.6 mg/dL [1.47 mmol/L], inclusive) [ Time Frame: at Week 8 ]
  • Change from baseline in serum phosphorus level [ Time Frame: at Week 4 ]
  • Proportion of patients with adverse events [ Time Frame: up to 8 weeks ]
  • Clinically significant changes in vital signs and clinical laboratory parameters (hematology, clinical chemistry, and lipid panel) [ Time Frame: up to 8 weeks ]


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: December 20, 2016
Date Started: May 2017
Date Completion: August 2018
Last Updated: December 21, 2016
Last Verified: December 2016