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

Primary Purpose

Hyperphosphatemia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Placebo
Sevelamer Carbonate (GZ419831)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 1560003
  • Investigational Site Number 1560026
  • Investigational Site Number 1560015
  • Investigational Site Number 1560011
  • Investigational Site Number 1560030
  • Investigational Site Number 1560019
  • Investigational Site Number 1560013
  • Investigational Site Number 1560001
  • Investigational Site Number 1560027
  • Investigational Site Number 1560037
  • Investigational Site Number 1560031
  • Investigational Site Number 1560036
  • Investigational Site Number 1560039
  • Investigational Site Number 1560023
  • Investigational Site Number 1560033
  • Investigational Site Number 1560034
  • Investigational Site Number 1560006
  • Investigational Site Number 1560004
  • Investigational Site Number 1560005
  • Investigational Site Number 1560032
  • Investigational Site Number 1560017
  • Investigational Site Number 1560029
  • Investigational Site Number 1560028
  • Investigational Site Number 1560002
  • Investigational Site Number 1560007
  • Investigational Site Number 1560021
  • Investigational Site Number 1560038
  • Investigational Site Number 1560025
  • Investigational Site Number 1560022
  • Investigational Site Number 1560012
  • Investigational Site Number 1560014
  • Investigational Site Number 1560010
  • Investigational Site Number 1560008
  • Investigational Site Number 1560020
  • Investigational Site Number 1560018
  • Investigational Site Number 1560035
  • Investigational Site Number 1560024
  • Investigational Site Number 1560016

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Renvela

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in Total Cholesterol at Week 8
Missing Week 8 data were imputed by LOCF method.
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8
Missing Week 8 data were imputed by LOCF method.
Change From Baseline in Calcium-Phosphorus Product at Week 8
Missing Week 8 data were imputed by LOCF method.
Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8
Missing Week 8 data were imputed by LOCF method.
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.
Change From Baseline in Serum Phosphorus Level at Week 4
Missing Week 4 data were imputed by LOCF method.
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.
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)
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.
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.
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.
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.
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.

Full Information

First Posted
December 20, 2016
Last Updated
March 15, 2022
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03001011
Brief Title
Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China
Acronym
RECOVER
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
August 16, 2019 (Actual)
Study Completion Date
August 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Renvela
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Sevelamer Carbonate (GZ419831)
Other Intervention Name(s)
Renvela
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Change From Baseline in Serum Phosphorus at Week 8
Description
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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Cholesterol at Week 8
Description
Missing Week 8 data were imputed by LOCF method.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8
Description
Missing Week 8 data were imputed by LOCF method.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Calcium-Phosphorus Product at Week 8
Description
Missing Week 8 data were imputed by LOCF method.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8
Description
Missing Week 8 data were imputed by LOCF method.
Time Frame
Baseline, Week 8
Title
Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8
Description
Missing Week 8 data were imputed by LOCF method.
Time Frame
Week 8
Title
Change From Baseline in Serum Phosphorus Level at Week 4
Description
Missing Week 4 data were imputed by LOCF method.
Time Frame
Baseline, Week 4
Title
Number of Participants With Treatment Emergent Adverse Event
Description
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.
Time Frame
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Title
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters
Description
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)
Time Frame
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Title
Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters
Description
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.
Time Frame
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Title
Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes
Description
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.
Time Frame
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Title
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters
Description
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.
Time Frame
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Title
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters
Description
Criteria for potentially clinically significant abnormalities: Alanine Aminotransferase (ALT): >3 ULN; >5 ULN; >10 ULN; Aspartate aminotransferase (AST): >3 ULN.
Time Frame
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Title
Number of Participants With Clinically Significant Vital Signs Abnormalities
Description
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.
Time Frame
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 1560003
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Investigational Site Number 1560026
City
Cangzhou
ZIP/Postal Code
061000
Country
China
Facility Name
Investigational Site Number 1560015
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Investigational Site Number 1560011
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
Investigational Site Number 1560030
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Investigational Site Number 1560019
City
Dalian
ZIP/Postal Code
116011
Country
China
Facility Name
Investigational Site Number 1560013
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Facility Name
Investigational Site Number 1560001
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Investigational Site Number 1560027
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Investigational Site Number 1560037
City
Guilin
Country
China
Facility Name
Investigational Site Number 1560031
City
Haikou
ZIP/Postal Code
570311
Country
China
Facility Name
Investigational Site Number 1560036
City
Hengyang
ZIP/Postal Code
421001
Country
China
Facility Name
Investigational Site Number 1560039
City
Hengyang
ZIP/Postal Code
421001
Country
China
Facility Name
Investigational Site Number 1560023
City
Hohhot
ZIP/Postal Code
010050
Country
China
Facility Name
Investigational Site Number 1560033
City
Kunming
Country
China
Facility Name
Investigational Site Number 1560034
City
Kunming
Country
China
Facility Name
Investigational Site Number 1560006
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Facility Name
Investigational Site Number 1560004
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Investigational Site Number 1560005
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Investigational Site Number 1560032
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Investigational Site Number 1560017
City
Nanjing
ZIP/Postal Code
210011
Country
China
Facility Name
Investigational Site Number 1560029
City
Nanning
Country
China
Facility Name
Investigational Site Number 1560028
City
Ningbo
Country
China
Facility Name
Investigational Site Number 1560002
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Investigational Site Number 1560007
City
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Investigational Site Number 1560021
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
Investigational Site Number 1560038
City
Shenyang
ZIP/Postal Code
110016
Country
China
Facility Name
Investigational Site Number 1560025
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Facility Name
Investigational Site Number 1560022
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
Investigational Site Number 1560012
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Investigational Site Number 1560014
City
Tianjin
ZIP/Postal Code
300121
Country
China
Facility Name
Investigational Site Number 1560010
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Investigational Site Number 1560008
City
Xi'An
ZIP/Postal Code
710061
Country
China
Facility Name
Investigational Site Number 1560020
City
Xiamen
ZIP/Postal Code
361003
Country
China
Facility Name
Investigational Site Number 1560018
City
Xiamen
ZIP/Postal Code
361004
Country
China
Facility Name
Investigational Site Number 1560035
City
Xuzhou
ZIP/Postal Code
221002
Country
China
Facility Name
Investigational Site Number 1560024
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Facility Name
Investigational Site Number 1560016
City
Zhanjiang
ZIP/Postal Code
524001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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

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

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