Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China
- Conditions
- Hyperphosphatemia
- Interventions
- Drug: Placebo
- Registration Number
- NCT03001011
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Renvela Sevelamer Carbonate (GZ419831) 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). Placebo Placebo 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).
- Primary Outcome Measures
Name Time Method Change From Baseline in Serum Phosphorus at Week 8 Baseline, 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
Name Time Method Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 Baseline, Week 8 Missing Week 8 data were imputed by LOCF method.
Change From Baseline in Total Cholesterol at Week 8 Baseline, Week 8 Missing Week 8 data were imputed by LOCF method.
Change From Baseline in Serum Phosphorus Level at Week 4 Baseline, Week 4 Missing Week 4 data were imputed by LOCF method.
Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 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.Change From Baseline in Calcium-Phosphorus Product at Week 8 Baseline, Week 8 Missing Week 8 data were imputed by LOCF method.
Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8 Baseline, Week 8 Missing Week 8 data were imputed by LOCF method.
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 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 Vital Signs Abnormalities From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 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.Number of Participants With Treatment Emergent Adverse Event From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 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: Electrolytes From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 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.Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8 Week 8 Missing Week 8 data were imputed by LOCF method.
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 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 From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59 Criteria for potentially clinically significant abnormalities:
Alanine Aminotransferase (ALT): \>3 ULN; \>5 ULN; \>10 ULN; Aspartate aminotransferase (AST): \>3 ULN.
Trial Locations
- Locations (38)
Investigational Site Number 1560001
🇨🇳Guangzhou, China
Investigational Site Number 1560003
🇨🇳Beijing, China
Investigational Site Number 1560015
🇨🇳Changchun, China
Investigational Site Number 1560026
🇨🇳Cangzhou, 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 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 1560034
🇨🇳Kunming, China
Investigational Site Number 1560023
🇨🇳Hohhot, China
Investigational Site Number 1560033
🇨🇳Kunming, China
Investigational Site Number 1560006
🇨🇳Lanzhou, China
Investigational Site Number 1560004
🇨🇳Nanchang, China
Investigational Site Number 1560032
🇨🇳Nanchang, China
Investigational Site Number 1560005
🇨🇳Nanchang, China
Investigational Site Number 1560029
🇨🇳Nanning, China
Investigational Site Number 1560002
🇨🇳Shanghai, China
Investigational Site Number 1560028
🇨🇳Ningbo, China
Investigational Site Number 1560007
🇨🇳Shanghai, China
Investigational Site Number 1560021
🇨🇳Shenyang, China
Investigational Site Number 1560038
🇨🇳Shenyang, China
Investigational Site Number 1560022
🇨🇳Taiyuan, China
Investigational Site Number 1560012
🇨🇳Tianjin, China
Investigational Site Number 1560025
🇨🇳Shijiazhuang, China
Investigational Site Number 1560018
🇨🇳Xiamen, China
Investigational Site Number 1560014
🇨🇳Tianjin, China
Investigational Site Number 1560010
🇨🇳Wuhan, China
Investigational Site Number 1560008
🇨🇳Xi'An, China
Investigational Site Number 1560035
🇨🇳Xuzhou, China
Investigational Site Number 1560020
🇨🇳Xiamen, China
Investigational Site Number 1560024
🇨🇳Yinchuan, China
Investigational Site Number 1560016
🇨🇳Zhanjiang, China
Investigational Site Number 1560017
🇨🇳Nanjing, China