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HyperphosphatemiaPhase 3RECOVERNCT03001011

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

A Phase 3 study testing Sevelamer Carbonate (GZ419831) in people with Hyperphosphatemia, run by Sanofi at 38 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperphosphatemia
What is being tested?
Sevelamer Carbonate (GZ419831)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
38 sitesChina
Study dates
7 Jun 2017to 16 Aug 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

China38 sites

  • Investigational Site Number 1560003

    Beijing, 100034

  • Investigational Site Number 1560026

    Cangzhou, 061000

  • Investigational Site Number 1560015

    Changchun, 130021

  • Investigational Site Number 1560011

    Changsha, 410011

  • Investigational Site Number 1560030

    Chongqing, 400038

  • Investigational Site Number 1560019

    Dalian, 116011

  • Investigational Site Number 1560013

    Fuzhou, 350005

  • Investigational Site Number 1560001

    Guangzhou, 510080

  • Investigational Site Number 1560027

    Guangzhou, 510120

  • Investigational Site Number 1560037

    Guilin

  • Investigational Site Number 1560031

    Haikou, 570311

  • Investigational Site Number 1560036

    Hengyang, 421001

  • Investigational Site Number 1560039

    Hengyang, 421001

  • Investigational Site Number 1560023

    Hohhot, 010050

  • Investigational Site Number 1560033

    Kunming

  • Investigational Site Number 1560034

    Kunming

  • Investigational Site Number 1560006

    Lanzhou, 730030

  • Investigational Site Number 1560004

    Nanchang, 330006

  • Investigational Site Number 1560005

    Nanchang, 330006

  • Investigational Site Number 1560032

    Nanchang, 330006

  • Investigational Site Number 1560017

    Nanjing, 210011

  • Investigational Site Number 1560029

    Nanning

  • Investigational Site Number 1560028

    Ningbo

  • Investigational Site Number 1560002

    Shanghai, 200025

  • Investigational Site Number 1560007

    Shanghai, 200072

  • Investigational Site Number 1560021

    Shenyang, 110004

  • Investigational Site Number 1560038

    Shenyang, 110016

  • Investigational Site Number 1560025

    Shijiazhuang, 050000

  • Investigational Site Number 1560022

    Taiyuan, 030001

  • Investigational Site Number 1560012

    Tianjin, 300052

  • Investigational Site Number 1560014

    Tianjin, 300121

  • Investigational Site Number 1560010

    Wuhan, 430030

  • Investigational Site Number 1560008

    Xi'an, 710061

  • Investigational Site Number 1560020

    Xiamen, 361003

  • Investigational Site Number 1560018

    Xiamen, 361004

  • Investigational Site Number 1560035

    Xuzhou, 221002

  • Investigational Site Number 1560024

    Yinchuan, 750004

  • Investigational Site Number 1560016

    Zhanjiang, 524001

Other trials in China

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

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

Being tested
Placebo, Sevelamer Carbonate (GZ419831)
Medical subject headings
Hyperphosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • Sevelamer Carbonate (GZ419831)Drug

    Also called Renvela

    Pharmaceutical form: tablet

    Route of administration: oral

Study groups in NCT03001011
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants 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).
Receives: Drug: Placebo
RenvelaExperimentalParticipants 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).
Receives: Drug: Sevelamer Carbonate (GZ419831)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 8

Secondary outcomes (13)

  1. Change From Baseline in Total Cholesterol at Week 8

    Missing Week 8 data were imputed by LOCF method.

    Measured: Baseline, Week 8

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

    Missing Week 8 data were imputed by LOCF method.

    Measured: Baseline, Week 8

  3. Change From Baseline in Calcium-Phosphorus Product at Week 8

    Missing Week 8 data were imputed by LOCF method.

    Measured: Baseline, Week 8

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

    Missing Week 8 data were imputed by LOCF method.

    Measured: Baseline, Week 8

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

    Missing Week 8 data were imputed by LOCF method.

    Measured: Week 8

  6. Change From Baseline in Serum Phosphorus Level at Week 4

    Missing Week 4 data were imputed by LOCF method.

    Measured: Baseline, Week 4

  7. Number of Participants With Treatment Emergent Adverse Event

    Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an Adverse Event (AE) without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during TEAE period. On-treatment period was defined as the (time from the first dose of IMP to the last dose of IMP+3 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

    Measured: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59

  8. Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters

    Criteria for potentially clinically significant abnormalities:

    • Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female [F]); >=185 g/L (M) or >=165 g/L (F); Decrease from baseline (DFB) >=20 g/L
    • Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F)
    • Red blood cells (RBC): >=6 Tera/L
    • Platelets: <100 Giga/L; >=700 Giga/L
    • White blood cells (WBC): <3.0 Giga/L (Non-Black [NB]) or <2.0 Giga/L (Black [B]); >=16.0 Giga/L
    • Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L
    • Lymphocytes: >4.0 Giga/L
    • Monocytes: >0.7 Giga/L
    • Basophils: >0.1 Giga/L
    • Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)

    Measured: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59

  9. Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters

    Criteria for potentially clinically significant abnormalities:

    • Glucose: <=3.9 mmol/L and < lower limits of normal (LLN); >=11.1 mmol/L (unfasted [unfas]) or >=7 mmol/L (fasted [fas])
    • Triglycerides: >=4.6 mmol/L
    • Albumin: <= 25 g/L.

    Measured: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59

  10. Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes

    Criteria for potentially clinically significant abnormalities:

    Sodium: <=129 millimoles (mmol)/L; >=160 mmol/L Potassium: <3 mmol/L; >=5.5 mmol/L Chloride: <80 mmol/L; >115 mmol/L.

    Measured: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59

  11. Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters

    Criteria for potentially clinically significant abnormalities:

    Creatinine: >=150 micromol/L; >=30% change from baseline, >=100% change from baseline Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to <60 mL/min; >=60 to <90 mL/min Blood urea nitrogen: >=17 mmol/L Uric acid: <120 micromol/L; >408 micromol/L Glomular Filtration Rate (GFR): < 15 mL/min/1.73m^2, >= 15 - < 30 mL/min/1.73m^2, >= 30 - < 60 mL/min/1.73m^2, >= 60 - < 90 mL/min/1.73m^2.

    Measured: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59

  12. Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters

    Criteria for potentially clinically significant abnormalities:

    Alanine Aminotransferase (ALT): >3 ULN; >5 ULN; >10 ULN; Aspartate aminotransferase (AST): >3 ULN.

    Measured: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59

  13. Number of Participants With Clinically Significant Vital Signs Abnormalities

    Criteria for potentially clinically significant vital sign abnormalities:

    Systolic blood pressure (SBP) supine: <=95 millimeters of mercury (mmHg) and DFB >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg Diastolic blood pressure (DBP) supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg Heart rate (HR) supine: <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm Weight: >=5% DFB; >=5% IFB.

    Measured: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2016 (estimated)
  2. Study start7 Jun 2017
  3. Primary completion16 Aug 2019
  4. Study completion16 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03001011
Sponsor's protocol ID
EFC14011
Other IDs
U1111-1161-9850
Acronym
RECOVER
Status last verified
Mar 2022
First submitted
20 Dec 2016
Last updated
25 Mar 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • 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.

    PubMed 40576086

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sevelamer Carbonate (GZ419831) in people with Hyperphosphatemia, run by Sanofi at 38 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Serum Phosphorus at Week 8 (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03001011, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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