Trial Outcomes & Findings for Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China (NCT NCT03001011)

NCT ID: NCT03001011

Last Updated: 2022-03-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 202 participants
• Primary outcome timeframe: Baseline, Week 8
• Results posted on: 2022-03-25

Participant Flow

Study was conducted at 38 centers in China. A total of 482 participants were screened between 07 June 2017 & 30 May 2019, of which 280 participants were screen failures. Screen failures were mainly due to serum phosphorus level greater than or equal to >=5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per litre [mmol/L]) at screening visit.

A total of 202 participants were randomized in the study. Randomization was stratified according to screening serum phosphorus level (>=5.5 - 6.0 mg/dL [1.78 - 1.94 mmol/L] and >6.0 mg/dL [1.94 mmol/L]). Assignment to arms was done centrally using interactive voice/web response system in 1:1 ratio (Renvela [sevelamer carbonate]: placebo).

Participant milestones

Measure	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).	Renvela 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).
Overall Study STARTED	101	101
Overall Study COMPLETED	74	80
Overall Study NOT COMPLETED	27	21

Reasons for withdrawal

Measure	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).	Renvela 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).
Overall Study Adverse Event	9	3
Overall Study Chronic kidney disease lead to dialysis	15	10
Overall Study Other than specified above	3	8

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=101 Participants Participants received placebo (for 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).	Renvela n=101 Participants 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).	Total n=202 Participants Total of all reporting groups
Age, Continuous	50.9 years STANDARD_DEVIATION 12.4 • n=5 Participants	50.6 years STANDARD_DEVIATION 13.5 • n=7 Participants	50.7 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	48 Participants n=7 Participants	94 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	53 Participants n=7 Participants	108 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	101 Participants n=5 Participants	101 Participants n=7 Participants	202 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: Modified intention to treat (mITT) population: all participants who were randomized, received at least 1 dose of IMP \& had both baseline assessment \& at least 1 post-baseline assessment of phosphorus measure. Here, number analyzed = participants with available data at specified time points.

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.

Outcome measures

Measure	Placebo n=93 Participants Participants received placebo (for 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).	Renvela n=98 Participants 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).
Change From Baseline in Serum Phosphorus at Week 8 Baseline	2.090 mmol/L Interval 1.87 to 2.27	2.095 mmol/L Interval 1.87 to 2.4
Change From Baseline in Serum Phosphorus at Week 8 Change at Week 8	0.010 mmol/L Interval -0.2 to 0.25	-0.200 mmol/L Interval -0.49 to 0.02

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.

Missing Week 8 data were imputed by LOCF method.

Outcome measures

Measure	Placebo n=82 Participants Participants received placebo (for 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).	Renvela n=89 Participants 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).
Change From Baseline in Total Cholesterol at Week 8	-0.115 mmol/L Interval -1.82 to 1.54	-0.830 mmol/L Interval -4.45 to 0.74

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.

Missing Week 8 data were imputed by LOCF method.

Outcome measures

Measure	Placebo n=81 Participants Participants received placebo (for 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).	Renvela n=86 Participants 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).
Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8	-0.030 mmol/L Interval -1.61 to 1.3	-0.830 mmol/L Interval -3.31 to 0.51

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.

Missing Week 8 data were imputed by LOCF method.

Outcome measures

Measure	Placebo n=90 Participants Participants received placebo (for 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).	Renvela n=97 Participants 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).
Change From Baseline in Calcium-Phosphorus Product at Week 8	0.0200 mmol^2/L^2 Interval -2.648 to 2.936	-0.4960 mmol^2/L^2 Interval -2.592 to 2.696

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.

Missing Week 8 data were imputed by LOCF method.

Outcome measures

Measure	Placebo n=91 Participants Participants received placebo (for 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).	Renvela n=97 Participants 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).
Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8	7.2380 nanogram per liter (ng/L) Interval -298.732 to 573.306	0.0000 nanogram per liter (ng/L) Interval -370.172 to 327.966

SECONDARY outcome

Timeframe: Week 8

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.

Missing Week 8 data were imputed by LOCF method.

Outcome measures

Measure	Placebo n=91 Participants Participants received placebo (for 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).	Renvela n=97 Participants 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).
Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8	6.6 percentage of participants	15.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.

Missing Week 4 data were imputed by LOCF method.

Outcome measures

Measure	Placebo n=91 Participants Participants received placebo (for 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).	Renvela n=97 Participants 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).
Change From Baseline in Serum Phosphorus Level at Week 4	-0.020 mmol/L Interval -1.56 to 2.42	-0.240 mmol/L Interval -1.03 to 1.39

SECONDARY outcome

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

Population: Analysis was performed on safety population that consisted of all randomized participants who received at least one dose of IMP.

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.

Outcome measures

Measure	Placebo n=101 Participants Participants received placebo (for 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).	Renvela n=101 Participants 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).
Number of Participants With Treatment Emergent Adverse Event Any TEAE	86 Participants	83 Participants
Number of Participants With Treatment Emergent Adverse Event Any Treatment emergent SAE	31 Participants	26 Participants
Number of Participants With Treatment Emergent Adverse Event any TEAE leading to permanent discontinuation	21 Participants	12 Participants

SECONDARY outcome

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

Population: Analysis was performed on safety population. Here, number analyzed = participants with available data for the specified categories.

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)

Outcome measures

Measure	Placebo n=101 Participants Participants received placebo (for 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).	Renvela n=101 Participants 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).
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Platelets <100 Giga/L	3 Participants	4 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Lymphocytes >4 Giga/L	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Hemoglobin <=115 g/L (M) or <=95 g/L (F)	59 Participants	54 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Hemoglobin >=185 g/L (M) or >=165 g/L (F)	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Hemoglobin DFB >=20 g/L	9 Participants	6 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Hematocrit <=0.37 v/v (M) or <=0.32 v/v (F)	68 Participants	67 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Hematocrit >0.55 v/v (M) or >=0.5 v/v (F)	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters RBC >=6 Tera/L	0 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Platelets >=700 Giga/L	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters WBC <3.0 Giga/L (NB) or <2.0 Giga/L (B)	2 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters WBC >=16.0 Giga/L	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Neutrophils <1.5 Giga/L (NB) or <1.0 Giga/L (B)	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Monocytes >0.7 Giga/L	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Basophils >0.1 Giga/L	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters Eosinophils >0.5 Giga/L or >ULN (ULN >=0.5 Giga/L)	4 Participants	6 Participants

SECONDARY outcome

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

Population: Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.

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.

Outcome measures

Measure	Placebo n=101 Participants Participants received placebo (for 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).	Renvela n=101 Participants 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).
Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters Triglycerides: >=4.6 mmol/L	0 Participants	2 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters Glucose: =< 3.9 mmol/L and < LLN	1 Participants	1 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters Glucose: >=11.1 mmol/L(unfas); >=7 mmol/L(fas)	5 Participants	6 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters Albumin: <= 25 g/L	1 Participants	0 Participants

SECONDARY outcome

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

Population: Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.

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.

Outcome measures

Measure	Placebo n=101 Participants Participants received placebo (for 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).	Renvela n=101 Participants 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).
Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes Sodium <=129 mmol/L	1 Participants	3 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes Sodium >=160 mmol/L	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes Potassium <3 mmol/L	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes Potassium >=5.5 mmol/L	36 Participants	46 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes Chloride <80 mmol/L	0 Participants	2 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes Chloride >115 mmol/L	0 Participants	0 Participants

SECONDARY outcome

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

Population: Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.

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.

Outcome measures

Measure	Placebo n=101 Participants Participants received placebo (for 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).	Renvela n=101 Participants 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).
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters Creatinine >=150 micromol/L	84 Participants	89 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters Creatinine >=30% change from baseline	15 Participants	33 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters Creatinine >=100% change from baseline	3 Participants	3 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters Creatinine Clearance <15 mL/min	77 Participants	81 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters Creatinine clearance >=15 to <30 mL/min	6 Participants	8 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters Creatinine clearance >=30 to <60 mL/min	1 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters Creatinine clearance >=60 to <90 mL/min	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters Blood Urea Nitrogen >=17 mmol/L	77 Participants	83 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters Uric acid <120 micromol/L	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters Uric acid >408 micromol/L	56 Participants	67 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters GFR < 15 mL/min/1.73m^2	82 Participants	86 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters GFR >= 15 - < 30 mL/min/1.73m^2	2 Participants	3 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters GFR >= 30 - < 60 mL/min/1.73m^2	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters GFR >= 60 - < 90 mL/min/1.73m^2	0 Participants	0 Participants

SECONDARY outcome

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

Population: Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.

Criteria for potentially clinically significant abnormalities:

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

Outcome measures

Measure	Placebo n=101 Participants Participants received placebo (for 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).	Renvela n=101 Participants 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).
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters ALT >3 ULN	1 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters ALT >5 ULN	1 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters ALT >10 ULN	0 Participants	0 Participants
Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters AST >3 ULN	0 Participants	0 Participants

SECONDARY outcome

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

Population: Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.

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.

Outcome measures

Measure	Placebo n=101 Participants Participants received placebo (for 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).	Renvela n=101 Participants 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).
Number of Participants With Clinically Significant Vital Signs Abnormalities HR (supine) >=120 bpm and IFB >=20 bpm	0 Participants	0 Participants
Number of Participants With Clinically Significant Vital Signs Abnormalities SBP (supine) <=95 mmHg and DFB >=20 mmHg	0 Participants	0 Participants
Number of Participants With Clinically Significant Vital Signs Abnormalities SBP (supine) >=160 mmHg and IFB >=20 mmHg	17 Participants	12 Participants
Number of Participants With Clinically Significant Vital Signs Abnormalities DBP (supine) <=45 mmHg and DFB >=10 mmHg	0 Participants	0 Participants
Number of Participants With Clinically Significant Vital Signs Abnormalities DBP (supine) >=110 mmHg and IFB >=10 mmHg	2 Participants	3 Participants
Number of Participants With Clinically Significant Vital Signs Abnormalities HR (supine) <=50 bpm and DFB >= 20 bpm	0 Participants	0 Participants
Number of Participants With Clinically Significant Vital Signs Abnormalities Weight >=5% DFB	12 Participants	7 Participants
Number of Participants With Clinically Significant Vital Signs Abnormalities Weight >=5% IFB	14 Participants	9 Participants

Adverse Events

Placebo

Serious events: 31 serious events

Other events: 52 other events

Deaths: 0 deaths

Renvela

Serious events: 26 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=101 participants at risk Participants received placebo (for Renvela) orally TID with meals up to 8 weeks as directed by physician and were titrated to reach a target goal of serum phosphorus \<=4.6 mg/dL (\<=1.49 mmol/L).	Renvela n=101 participants at risk Participants received Renvela orally TID with meals up to 8 weeks as directed by physician and were titrated to reach a target goal of serum phosphorus \<=4.6 mg/dL (\<=1.49 mmol/L).
Blood and lymphatic system disorders Anaemia	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Cardiac disorders Angina Pectoris	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Cardiac disorders Cardiac Failure	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Cardiac disorders Cardiac Failure Acute	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Eye disorders Cataract	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Hepatobiliary disorders Cholelithiasis	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Infections and infestations Lung Infection	2.0% 2/101 • Number of events 2 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	2.0% 2/101 • Number of events 2 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Infections and infestations Pulmonary Tuberculosis	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Infections and infestations Urinary Tract Infection	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Metabolism and nutrition disorders Hyperkalaemia	2.0% 2/101 • Number of events 2 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	2.0% 2/101 • Number of events 2 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Musculoskeletal and connective tissue disorders Myofascitis	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Nervous system disorders Cerebral Haemorrhage	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Renal and urinary disorders Acute Kidney Injury	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Renal and urinary disorders Azotaemia	4.0% 4/101 • Number of events 4 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Renal and urinary disorders Chronic Kidney Disease	12.9% 13/101 • Number of events 14 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	7.9% 8/101 • Number of events 8 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Renal and urinary disorders Diabetic Nephropathy	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Renal and urinary disorders End Stage Renal Disease	6.9% 7/101 • Number of events 8 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	8.9% 9/101 • Number of events 9 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Renal and urinary disorders Glomerulonephritis Chronic	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Renal and urinary disorders Renal Impairment	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Skin and subcutaneous tissue disorders Psoriasis	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Surgical and medical procedures Arteriovenous Fistula Operation	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Vascular disorders Hypertension	0.00% 0/101 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	0.99% 1/101 • Number of events 1 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.

Other adverse events

Measure	Placebo n=101 participants at risk Participants received placebo (for Renvela) orally TID with meals up to 8 weeks as directed by physician and were titrated to reach a target goal of serum phosphorus \<=4.6 mg/dL (\<=1.49 mmol/L).	Renvela n=101 participants at risk Participants received Renvela orally TID with meals up to 8 weeks as directed by physician and were titrated to reach a target goal of serum phosphorus \<=4.6 mg/dL (\<=1.49 mmol/L).
Gastrointestinal disorders Abdominal Distension	5.0% 5/101 • Number of events 5 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	5.9% 6/101 • Number of events 7 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Gastrointestinal disorders Constipation	5.0% 5/101 • Number of events 5 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	6.9% 7/101 • Number of events 8 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Gastrointestinal disorders Diarrhoea	7.9% 8/101 • Number of events 10 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	5.0% 5/101 • Number of events 5 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Gastrointestinal disorders Nausea	14.9% 15/101 • Number of events 15 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	9.9% 10/101 • Number of events 11 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Gastrointestinal disorders Vomiting	12.9% 13/101 • Number of events 17 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	11.9% 12/101 • Number of events 20 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
General disorders Oedema Peripheral	8.9% 9/101 • Number of events 10 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	13.9% 14/101 • Number of events 14 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Infections and infestations Upper Respiratory Tract Infection	8.9% 9/101 • Number of events 9 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	7.9% 8/101 • Number of events 8 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Metabolism and nutrition disorders Decreased Appetite	10.9% 11/101 • Number of events 13 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	4.0% 4/101 • Number of events 4 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Metabolism and nutrition disorders Hyperkalaemia	17.8% 18/101 • Number of events 24 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	24.8% 25/101 • Number of events 31 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Metabolism and nutrition disorders Hypocalcaemia	7.9% 8/101 • Number of events 8 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	3.0% 3/101 • Number of events 3 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.
Metabolism and nutrition disorders Metabolic Acidosis	6.9% 7/101 • Number of events 7 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.	4.0% 4/101 • Number of events 5 • Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59). Analysis was performed on safety population.

Additional Information

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