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Clinical Trial Summary

Primary Objective:

To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in hyperphosphatemia in participants 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 participants reaching the target serum phosphorus level 4.6 milligrams per decilitre (mg/dL) (1.47 millimoles per litre [mmol/L], inclusive).

To evaluate safety of Renvela tablets.


Clinical Trial Description

The total duration of study period per participant was up to 14 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03001011
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date June 7, 2017
Completion date August 16, 2019

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