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Clinical Trial Details

Trial ID: L1574
Source ID: NCT03001011
Associated Drug: Placebo
Title: Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China
Acronym: RECOVER
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03001011/results
Conditions: Hyperphosphatemia
Interventions: DRUG: Placebo|DRUG: Sevelamer Carbonate (GZ419831)
Outcome Measures: 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|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|Change From Baseline in Calcium-Phosphorus Product at Week 8, Missing Week 8 data were imputed by LOCF method., Baseline, Week 8|Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8, Missing Week 8 data were imputed by LOCF method., Baseline, Week 8|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|Change From Baseline in Serum Phosphorus Level at Week 4, Missing Week 4 data were imputed by LOCF method., Baseline, Week 4|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|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|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|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|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|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|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
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 202
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-06-07
Completion Date: 2019-08-16
Results First Posted: 2020-07-28
Last Update Posted: 2022-03-25
Locations: Investigational Site Number 1560003, Beijing, 100034, China|Investigational Site Number 1560026, Cangzhou, 061000, China|Investigational Site Number 1560015, Changchun, 130021, China|Investigational Site Number 1560011, Changsha, 410011, China|Investigational Site Number 1560030, Chongqing, 400038, China|Investigational Site Number 1560019, Dalian, 116011, China|Investigational Site Number 1560013, Fuzhou, 350005, China|Investigational Site Number 1560001, Guangzhou, 510080, China|Investigational Site Number 1560027, Guangzhou, 510120, China|Investigational Site Number 1560037, Guilin, China|Investigational Site Number 1560031, Haikou, 570311, China|Investigational Site Number 1560036, Hengyang, 421001, China|Investigational Site Number 1560039, Hengyang, 421001, China|Investigational Site Number 1560023, Hohhot, 010050, China|Investigational Site Number 1560033, Kunming, China|Investigational Site Number 1560034, Kunming, China|Investigational Site Number 1560006, Lanzhou, 730030, China|Investigational Site Number 1560004, Nanchang, 330006, China|Investigational Site Number 1560005, Nanchang, 330006, China|Investigational Site Number 1560032, Nanchang, 330006, China|Investigational Site Number 1560017, Nanjing, 210011, China|Investigational Site Number 1560029, Nanning, China|Investigational Site Number 1560028, Ningbo, China|Investigational Site Number 1560002, Shanghai, 200025, China|Investigational Site Number 1560007, Shanghai, 200072, China|Investigational Site Number 1560021, Shenyang, 110004, China|Investigational Site Number 1560038, Shenyang, 110016, China|Investigational Site Number 1560025, Shijiazhuang, 050000, China|Investigational Site Number 1560022, Taiyuan, 030001, China|Investigational Site Number 1560012, Tianjin, 300052, China|Investigational Site Number 1560014, Tianjin, 300121, China|Investigational Site Number 1560010, Wuhan, 430030, China|Investigational Site Number 1560008, Xi'An, 710061, China|Investigational Site Number 1560020, Xiamen, 361003, China|Investigational Site Number 1560018, Xiamen, 361004, China|Investigational Site Number 1560035, Xuzhou, 221002, China|Investigational Site Number 1560024, Yinchuan, 750004, China|Investigational Site Number 1560016, Zhanjiang, 524001, China
URL: https://clinicaltrials.gov/show/NCT03001011