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

NCT03001011 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: EFC14011U1111-1161-9850
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 38

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.

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Serum Phosphorus at Week 8

  Baseline of serum phosphorus value was the last serum phosphorus level obtained before the first double-blind investigational medicinal product (IMP) dosing. Missing Week 8 data were imputed by last observation carried forward \[LOCF\] method.

  Baseline, Week 8

Secondary Outcomes (13)

• Change From Baseline in Total Cholesterol at Week 8

  Baseline, Week 8

• Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8

  Baseline, Week 8

• Change From Baseline in Calcium-Phosphorus Product at Week 8

  Baseline, Week 8

• Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8

  Baseline, Week 8

• Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8

  Week 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Renvela

EXPERIMENTAL

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).

Drug: Sevelamer Carbonate (GZ419831)

Interventions

Placebo DRUG

Pharmaceutical form: tablet Route of administration: oral

Placebo

Sevelamer Carbonate (GZ419831) DRUG

Pharmaceutical form: tablet Route of administration: oral

Also known as: Renvela

Renvela

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (38)

Investigational Site Number 1560003

Beijing, 100034, China

Location

Investigational Site Number 1560026

Cangzhou, 061000, China

Location

Investigational Site Number 1560015

Changchun, 130021, China

Location

Investigational Site Number 1560011

Changsha, 410011, China

Location

Investigational Site Number 1560030

Chongqing, 400038, China

Location

Investigational Site Number 1560019

Dalian, 116011, China

Location

Investigational Site Number 1560013

Fuzhou, 350005, China

Location

Investigational Site Number 1560001

Guangzhou, 510080, China

Location

Investigational Site Number 1560027

Guangzhou, 510120, China

Location

Investigational Site Number 1560037

Guilin, China

Location

Investigational Site Number 1560031

Haikou, 570311, China

Location

Investigational Site Number 1560036

Hengyang, 421001, China

Location

Investigational Site Number 1560039

Hengyang, 421001, China

Location

Investigational Site Number 1560023

Hohhot, 010050, China

Location

Investigational Site Number 1560033

Kunming, China

Location

Investigational Site Number 1560034

Kunming, China

Location

Investigational Site Number 1560006

Lanzhou, 730030, China

Location

Investigational Site Number 1560004

Nanchang, 330006, China

Location

Investigational Site Number 1560005

Nanchang, 330006, China

Location

Investigational Site Number 1560032

Nanchang, 330006, China

Location

Investigational Site Number 1560017

Nanjing, 210011, China

Location

Investigational Site Number 1560029

Nanning, China

Location

Investigational Site Number 1560028

Ningbo, China

Location

Investigational Site Number 1560002

Shanghai, 200025, China

Location

Investigational Site Number 1560007

Shanghai, 200072, China

Location

Investigational Site Number 1560021

Shenyang, 110004, China

Location

Investigational Site Number 1560038

Shenyang, 110016, China

Location

Investigational Site Number 1560025

Shijiazhuang, 050000, China

Location

Investigational Site Number 1560022

Taiyuan, 030001, China

Location

Investigational Site Number 1560012

Tianjin, 300052, China

Location

Investigational Site Number 1560014

Tianjin, 300121, China

Location

Investigational Site Number 1560010

Wuhan, 430030, China

Location

Investigational Site Number 1560008

Xi'an, 710061, China

Location

Investigational Site Number 1560020

Xiamen, 361003, China

Location

Investigational Site Number 1560018

Xiamen, 361004, China

Location

Investigational Site Number 1560035

Xuzhou, 221002, China

Location

Investigational Site Number 1560024

Yinchuan, 750004, China

Location

Investigational Site Number 1560016

Zhanjiang, 524001, China

Location

Related Publications (1)

• 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.

  PMID: 40576086 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 22, 2016
• Study Start: June 7, 2017
• Primary Completion: August 16, 2019
• Study Completion: August 16, 2019
• Last Updated: March 25, 2022
• Results First Posted: July 28, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (38)