Efficacy and Safety of Cinacalcet in Pediatric Patients W... | NCT02138838

ID	Type	Description	Link
2013-004958-18	EudraCT Number

Label	Type	Description	Intervention Names
Standard of Care	Active Comparator	Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.	Dietary Supplement: Standard of Care
Cinacalcet	Experimental	In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.	Drug: Cinacalcet HCl Dietary Supplement: Standard of Care

Name	Type	Description	Arm Group Labels	Other Names
Cinacalcet HCl	Drug	Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets.

Measure	Description	Time Frame
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15	Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated. This endpoint was the primary endpoint in the US only.	Baseline and weeks 11 to 15
Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period	Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated. This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint.	Baseline and the efficacy assessment period (EAP), weeks 17 to 20

Measure	Description	Time Frame
Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20		Efficacy assessment period, weeks 17 to 20
Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20		Baseline and weeks 17 to 20

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 6 - < 18 years
Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values ≥ 300 pg/mL during screening
Corrected calcium value of ≥ 8.8 mg/dL during screening
Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days prior to screening
Parent or legally acceptable representative has provided written informed consent and subject has provided written assent when required by institutional guidelines

Exclusion Criteria:

History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
Corrected QT interval (QTc) > 500 ms, using Bazett's formula
QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
Use of grapefruit juice, herbal medications, or potent cytochrome P450 3A4 (CYP3A4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Los Angeles	California	90027	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
30756425	Background	Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.
32367309	Background

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Standard of Care	Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
FG001	Cinacalcet	In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15

Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated.

This endpoint was the primary endpoint in the US only.

The analysis was conducted using the full analysis set; participants who had no week 11 or 15 iPTH values were considered non-responders (non-responder imputation).

Posted

Number

percentage of participants

Baseline and weeks 11 to 15

ID	Title	Description
OG000	Standard of Care	Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
OG001	Cinacalcet	In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.

Units	Counts
Participants	OG00028 OG00127

Title

Denominators

Categories

Title	Measurements
	OG00017.9 OG00125.9

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		Cochran-Mantel-Haenszel	Cochran-Mantel-Haenszel test stratified by baseline age group	0.48		Treatment Difference	8.1			2-Sided	95	-13.7	29.9			SOC+Cinacalcet - SOC		Superiority or Other (legacy)

Primary

Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period

Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated.

This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint.

The full analysis set (all randomized participants) was used for this analysis. For participants with no iPTH values in the EAP, the mean of the last 2 available postbaseline values was used. If only 1 postbaseline value was available, this value was used. If no postbaseline value was available, the participant was considered a non-responder.

Posted

Number

percentage of participants

Baseline and the efficacy assessment period (EAP), weeks 17 to 20

ID	Title	Description
OG000	Standard of Care	Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
OG001	Cinacalcet	In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.

Secondary

Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20

This analysis was conducted using the full analysis set. For participants with no iPTH values in the EAP, the mean of the last 2 available postbaseline values was used. If only 1 postbaseline value was available, this value was used. If no postbaseline value was available, the participant was considered a non-responder.

Posted

Number

percentage of participants

Efficacy assessment period, weeks 17 to 20

ID	Title	Description
OG000	Standard of Care	Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
OG001	Cinacalcet	In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.

Units	Counts
Participants

Secondary

Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20

This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and weeks 17 to 20

ID	Title	Description
OG000	Standard of Care	Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
OG001	Cinacalcet	In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.

Units	Counts
Participants	OG000

Secondary

Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20

This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and weeks 17 to 20

ID	Title	Description
OG000	Standard of Care	Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
OG001	Cinacalcet	In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.

Units	Counts
Participants	OG000

Secondary

Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20

This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline and weeks 17 to 20

ID	Title	Description
OG000	Standard of Care	Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
OG001	Cinacalcet	In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ileus	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Bacterial infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Device related infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Peritonitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Postoperative wound infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Soft tissue infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Device dislocation	Product Issues	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Renovascular hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0011 affected25 at risk
Palpitations	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Motion sickness	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Precocious puberty	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Eyelid oedema	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0011 affected25 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected30 at risk EG0011 affected25 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected30 at risk EG0011 affected25 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0011 affected25 at risk
Lip blister	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0013 affected25 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected30 at risk EG0010 affected25 at risk
Chills	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Influenza like illness	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Malaise	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0011 affected25 at risk
Vessel puncture site pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Cellulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Ear infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0012 affected25 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Hepatitis B	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Lip infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 affected30 at risk EG0012 affected25 at risk
Peritonitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0012 affected25 at risk
Respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Rhinitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0011 affected25 at risk
Sinusitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Viral pharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0011 affected25 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Post procedural oedema	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Procedural headache	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 affected30 at risk EG0010 affected25 at risk
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0011 affected25 at risk
Blood calcium decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0011 affected25 at risk
Blood parathyroid hormone decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Blood phosphorus decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Blood phosphorus increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Blood pressure increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Weight increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0002 affected30 at risk EG0010 affected25 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected30 at risk EG0016 affected25 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected30 at risk EG0013 affected25 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected30 at risk EG0010 affected25 at risk
Dizziness postural	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0004 affected30 at risk EG0011 affected25 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Neurological symptom	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0011 affected25 at risk
Device occlusion	Product Issues	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Haematuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Nasal discharge discolouration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk
Catheter placement	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0011 affected25 at risk
Catheter removal	Surgical and medical procedures	MedDRA 19.0	Systematic Assessment	EG0000 affected30 at risk EG0011 affected25 at risk
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0011 affected25 at risk
Venous stenosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected30 at risk EG0010 affected25 at risk

ID	Term
D051436	Renal Insufficiency, Chronic
D006962	Hyperparathyroidism, Secondary

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Title	Description
BG000	Standard of Care	Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
BG001	Cinacalcet	In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
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	Standard of Care	Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.			2	30	17	30
EG001	Cinacalcet	In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.			4	25	20	25