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

NCT03001011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2022-03-25

Study results available
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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.

Conditions

  • Hyperphosphatemia

Interventions

DRUG

Placebo

Pharmaceutical form: tablet Route of administration: oral

DRUG

Sevelamer Carbonate (GZ419831)

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-07
Primary Completion
2019-08-16
Completion
2019-08-16
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03001011 on ClinicalTrials.gov