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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03001011
Other study ID # EFC14011
Secondary ID U1111-1161-9850
Status Completed
Phase Phase 3
First received
Last updated
Start date June 7, 2017
Est. completion date August 16, 2019

Study information

Verified date March 2022
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 202
Est. completion date August 16, 2019
Est. primary completion date August 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Placebo
Pharmaceutical form: tablet Route of administration: oral
Sevelamer Carbonate (GZ419831)
Pharmaceutical form: tablet Route of administration: oral

Locations

Country Name City State
China 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 1560018 Xiamen
China Investigational Site Number 1560020 Xiamen
China Investigational Site Number 1560035 Xuzhou
China Investigational Site Number 1560024 Yinchuan
China Investigational Site Number 1560016 Zhanjiang

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change From Baseline in Total Cholesterol at Week 8 Missing Week 8 data were imputed by LOCF method. Baseline, Week 8
Secondary Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 Missing Week 8 data were imputed by LOCF method. Baseline, Week 8
Secondary Change From Baseline in Calcium-Phosphorus Product at Week 8 Missing Week 8 data were imputed by LOCF method. Baseline, Week 8
Secondary Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8 Missing Week 8 data were imputed by LOCF method. Baseline, Week 8
Secondary 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. Week 8
Secondary Change From Baseline in Serum Phosphorus Level at Week 4 Missing Week 4 data were imputed by LOCF method. Baseline, Week 4
Secondary 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. From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Secondary 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)
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Secondary 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.
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Secondary 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.
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Secondary 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.
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Secondary 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.
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
Secondary 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.
From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
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