NCT03001011

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

A Randomized, Double Blind, Parallel Group Study For Assessing The Efficacy And Safety Of Renvela® Tablets For The Treatment Of Hyperphosphatemia In Patients With Chronic Kidney Disease Not On Dialysis Versus Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	Placebo	Pharmaceutical form: tablet Route of administration: oral
DRUG	Sevelamer Carbonate (GZ419831)	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2017-06-07
• Primary completion: 2019-08-16
• Completion: 2019-08-16
• First posted: 2016-12-22
• Last updated: 2022-03-25
• Results posted: 2020-07-28

Locations

38 sites across 1 country: China

Regulatory

• FDA-regulated drug study