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

NCT ID: NCT03001011

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-07
• Study Completion Date: 2019-08-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Participants received placebo (for Renvela) orally 3 times per day (TID) for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus less than or equal to (\<=) 4.6 mg/dL (\<=1.49 mmol/L).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Renvela

Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus \<=4.6 mg/dL (\<=1.49 mmol/L).

Group Type: EXPERIMENTAL

Sevelamer Carbonate (GZ419831)

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Interventions

Placebo

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

Sevelamer Carbonate (GZ419831)

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

Other Intervention Names

Renvela

Eligibility Criteria

Inclusion Criteria

• Participants with chronic kidney disease who had not been on dialysis, and were not expected to begin dialysis, or renal transplantation in the next 4 months from the screening visit.
• Had serum phosphorus measurement greater than or equal to (>=) 5.5 mg/dL (1.78 mmol/L) at screening visit (if participants were not on phosphate binder[s] at Screening Visit) OR at the end of Washout Period (if participants were on phosphate binder[s] at screening visit).
• Had the following laboratory measurements at screening visit:

• 25-hydroxy vitamin D >=10 nanograms per milliliter (ng/mL).
• intact parathyroid hormone, intact parathyroid hormone (iPTH) <=800 picograms per millilitre (pg/mL).
• Signed written informed consent.

Exclusion Criteria

• Men or women below 18 years of age.
• Any technical/administrative reason that made it impossible to randomize the participant in the study.
• Was not of the level of understanding and willingness to cooperate with all visits and procedures, as described in the study protocol.
• Not yet received chronic kidney disease diet education before screening visit.
• Not willing and not able to avoid changes to diet during the study.
• Not willing or able to maintain screening doses of lipid lowering medication, 1, 25 dihydroxy vitamin D, and/or cinacalcet for the duration of the study, except for safety reasons.
• Not willing or not able to avoid antacids and phosphate binders containing aluminium, magnesium, calcium, or lanthanum for the duration of the study unless prescribed as an evening calcium supplement.
• Had participated in any other investigational drug studies within 30 days, or 5 half lives, whichever is longer, prior to screening visit.
• Conditions/situations such as:

• Participant was the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
• Uncooperative or any condition that could make the participant potentially non-compliant to the study procedures (for example, participants could not be contacted by phones as required in phone call visits).
• Evidence of active malignancy.
• Not on stable medical condition (for example, but not limited to, active ethanol or drug abuse [tobacco use acceptable]; documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus [HIV] infection), or had any clinically significant medical conditions.
• Had known hypersensitivity to sevelamer or any constituents of Renvela tablets.
• Had bowel obstruction, active dysphagia or swallowing disorder, or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.
• Using or plan to use anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
• Was pregnant or breast-feeding.
• If the participant was female, and of childbearing potential (pre-menopausal and not surgically sterile), was not willing to use an effective contraceptive method throughout the study.
• Had any condition, which in the opinion of the investigator would prohibit the participant's inclusion in the study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 1560003

Beijing, , China

Investigational Site Number 1560026

Cangzhou, , China

Investigational Site Number 1560015

Changchun, , China

Investigational Site Number 1560011

Changsha, , China

Investigational Site Number 1560030

Chongqing, , China

Investigational Site Number 1560019

Dalian, , China

Investigational Site Number 1560013

Fuzhou, , China

Investigational Site Number 1560001

Guangzhou, , China

Investigational Site Number 1560027

Guangzhou, , China

Investigational Site Number 1560037

Guilin, , China

Investigational Site Number 1560031

Haikou, , China

Investigational Site Number 1560036

Hengyang, , China

Investigational Site Number 1560039

Hengyang, , China

Investigational Site Number 1560023

Hohhot, , China

Investigational Site Number 1560033

Kunming, , China

Investigational Site Number 1560034

Kunming, , China

Investigational Site Number 1560006

Lanzhou, , China

Investigational Site Number 1560004

Nanchang, , China

Investigational Site Number 1560005

Nanchang, , China

Investigational Site Number 1560032

Nanchang, , China

Investigational Site Number 1560017

Nanjing, , China

Investigational Site Number 1560029

Nanning, , China

Investigational Site Number 1560028

Ningbo, , China

Investigational Site Number 1560002

Shanghai, , China

Investigational Site Number 1560007

Shanghai, , China

Investigational Site Number 1560021

Shenyang, , China

Investigational Site Number 1560038

Shenyang, , China

Investigational Site Number 1560025

Shijiazhuang, , China

Investigational Site Number 1560022

Taiyuan, , China

Investigational Site Number 1560012

Tianjin, , China

Investigational Site Number 1560014

Tianjin, , China

Investigational Site Number 1560010

Wuhan, , China

Investigational Site Number 1560008

Xi'an, , China

Investigational Site Number 1560020

Xiamen, , China

Investigational Site Number 1560018

Xiamen, , China

Investigational Site Number 1560035

Xuzhou, , China

Investigational Site Number 1560024

Yinchuan, , China

Investigational Site Number 1560016

Zhanjiang, , China

Countries

China

References

Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type: DERIVED

PMID: 40576086 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1161-9850

Identifier Type: OTHER

Identifier Source: secondary_id

EFC14011

Identifier Type: -

Identifier Source: org_study_id