Evaluation of Renvela in Patients With Chronic Kidney Dis... | NCT03001011

ID	Type	Description	Link
U1111-1161-9850	Other Identifier	UTN

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	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).	Drug: Placebo
Renvela	Experimental	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).	Drug: Sevelamer Carbonate (GZ419831)

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Pharmaceutical form: tablet Route of administration: oral	Placebo

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

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.

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 1560003		Beijing		100034	China
Investigational Site Number 1560026

PubMed Identifier	Type	Citation	Retractions
40576086	Derived	Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 13, 2018	Jun 24, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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.

Posted

Median

Full Range

mmol/L

Baseline, Week 8

ID	Title	Description
OG000	Placebo	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).
OG001	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).

Units	Counts
Participants	OG00093 OG00198

Title

Denominators

Categories

Baseline

- ParticipantsOG00093
- ParticipantsOG00198

Title	Measurements
	OG0002.090(1.870 to 2.270)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A hierarchical testing procedure was used to control type I error & handle multiple secondary endpoint analyses. Testing was then performed sequentially in order outcome measures (OM) are reported. The hierarchical testing sequence continued only when previous OM was statistically significant at 0.05 level.	Wilcoxon rank sum test		<0.0001	Threshold for statistical significance at 0.05.	Median difference (Renvela - Placebo)	-0.210			2-Sided						Renvela Vs. Placebo		Superiority

Secondary

Change From Baseline in Total Cholesterol at Week 8

Missing Week 8 data were imputed by LOCF method.

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

Posted

Median

Full Range

mmol/L

Baseline, Week 8

ID	Title	Description
OG000	Placebo	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).
OG001	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).

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8

Missing Week 8 data were imputed by LOCF method.

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

Posted

Median

Full Range

mmol/L

Baseline, Week 8

ID	Title	Description
OG000	Placebo	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).
OG001	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).

Units	Counts
Participants

Secondary

Change From Baseline in Calcium-Phosphorus Product at Week 8

Missing Week 8 data were imputed by LOCF method.

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

Posted

Median

Full Range

mmol^2/L^2

Baseline, Week 8

ID	Title	Description
OG000	Placebo	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).
OG001	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).

Units	Counts
Participants

Secondary

Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8

Missing Week 8 data were imputed by LOCF method.

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

Posted

Median

Full Range

nanogram per liter (ng/L)

Baseline, Week 8

ID	Title	Description
OG000	Placebo	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).
OG001	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).

Units	Counts
Participants

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.

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

Posted

Number

percentage of participants

Week 8

ID	Title	Description
OG000	Placebo	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).
OG001	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).

Units	Counts
Participants

Secondary

Change From Baseline in Serum Phosphorus Level at Week 4

Missing Week 4 data were imputed by LOCF method.

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

Posted

Median

Full Range

mmol/L

Baseline, Week 4

ID	Title	Description
OG000	Placebo	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).
OG001	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).

Units	Counts
Participants

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Placebo	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).
OG001	Renvela

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)

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Placebo	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]).
OG001	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).

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Placebo	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).
OG001	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).

Units

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Placebo	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).
OG001	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).

Units	Counts

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Placebo	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).
OG001	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).

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Placebo	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).
OG001	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).

Units	Counts

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Placebo	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).
OG001	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).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Angina Pectoris	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Cardiac Failure	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0011 events1 affected101 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Cataract	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected101 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected101 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected101 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected101 at risk
Lung Infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected101 at risk EG0012 events2 affected101 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected101 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected101 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected101 at risk EG0012 events2 affected101 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected101 at risk
Intervertebral Disc Disorder	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Myofascitis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Azotaemia	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected101 at risk EG0011 events1 affected101 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG00014 events13 affected101 at risk EG0018 events8 affected101 at risk
Diabetic Nephropathy	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected101 at risk
End Stage Renal Disease	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0008 events7 affected101 at risk EG0019 events9 affected101 at risk
Glomerulonephritis Chronic	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected101 at risk
Renal Impairment	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected101 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Arteriovenous Fistula Operation	Surgical and medical procedures	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected101 at risk EG0010 events0 affected101 at risk
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected101 at risk EG0011 events1 affected101 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Distension	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0005 events5 affected101 at risk EG0017 events6 affected101 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0005 events5 affected101 at risk EG0018 events7 affected101 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00010 events8 affected101 at risk EG0015 events5 affected101 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00015 events15 affected101 at risk EG00111 events10 affected101 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00017 events13 affected101 at risk EG00120 events12 affected101 at risk
Oedema Peripheral	General disorders	MedDRA 22.0	Systematic Assessment	EG00010 events9 affected101 at risk EG00114 events14 affected101 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0009 events9 affected101 at risk EG0018 events8 affected101 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00013 events11 affected101 at risk EG0014 events4 affected101 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00024 events18 affected101 at risk EG00131 events25 affected101 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0008 events8 affected101 at risk EG0013 events3 affected101 at risk
Metabolic Acidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0007 events7 affected101 at risk EG0015 events4 affected101 at risk

ID	Term
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals

ID	Title	Description
BG000	Placebo	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).
BG001	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).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	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).	0	101	31	101	52	101
EG001	Renvela	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).	0	101	26	101	60	101