Treatment of Autonomous Hyperparathyroidism in Post Renal... | NCT00975000

Label	Type	Description	Intervention Names
Cinacalcet	Experimental	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parthyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.	Drug: Cinacalcet
Placebo	Placebo Comparator	Participants received placebo orally once daily for 52 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Cinacalcet	Drug	Possible sequential doses are 30, 60, 90, 120, and 180 mg.	Cinacalcet

Measure	Description	Time Frame
Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)		Weeks 21 to 26 (EAP)

Measure	Description	Time Frame
Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck	Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).	Baseline and Week 52
Change From Baseline to the EAP in Mean Serum Phosphorus

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Received a kidney transplant ≥ 9 weeks at time of Screening and ≤ 24 months before first dose
May be the first kidney transplant or a repeat kidney transplant.
Subjects with a functional, stable kidney transplant, defined as MDRD estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² (chromic kidney disease stage 3 or better) at Screening.
Men or women ≥ 18 years at the start of Screening (ie, time of informed consent).
Corrected total serum calcium > 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2 values in Screening period.
iPTH > 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen 1 or Screen 2).

Exclusion Criteria:

Received cinacalcet therapy post-transplant for more than 14 days cumulatively post-transplant. If cinacalcet therapy was received for a total of 14 days or less post-transplant, there must be a 4-week washout before subject is eligible for screening (Note: This does not exclude pre-transplant use of cinacalcet).
Anticipated parathyroidectomy within 6 to12 months after Randomization.
Ongoing therapy with bisphosphonates or use within 6 months prior to Screening.
Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites or analogues) or use within 30 days prior to Screening.
Ongoing use of calcium supplements or use within 30 days prior to Screening.
Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30 days prior to Screening.
Ongoing use of a thiazide diuretic.
Subjects with a history of seizures who had a seizure within the 3 months prior to Randomization, which required adjustments to the seizure medication.
Acute Kidney Injury (AKI) or renal biopsy within 6 weeks prior to Screening, unless it is an institutional protocol-driven biopsy.

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Phoenix	Arizona	85012	United States
Research Site

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo orally once daily for 52 weeks.
FG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parathyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.

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 With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)

Full analysis set (all randomized participants excluding participants determined to have graft failure prior to week 26)

Posted

Number

percentage of participants

Weeks 21 to 26 (EAP)

ID	Title	Description
OG000	Placebo	Participants received placebo orally once daily for 52 weeks.
OG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.

Units	Counts
Participants	OG00057 OG00157

Title

Denominators

Categories

Title	Measurements
	OG0003.5 OG00178.9

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	The primary endpoint was tested at a significance level of 0.05.	Cochran-Mantel-Haenszel	Cochran-Mantel-Haenszel (CMH) test stratified by baseline corrected total serum calcium level (≤ 11.2 mg/dL and > 11.2 mg/dL)	<0.001		Chi-Square test statistic	66.437											Superiority or Other
OG000 OG001

Secondary

Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck

Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).

Full analysis set with available data

Posted

Median

Inter-Quartile Range

percent change

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo orally once daily for 52 weeks.
OG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to the EAP in Mean Serum Phosphorus

Full analysis set with available data

Posted

Mean

Standard Deviation

mg/dL

Baseline and the EAP (mean of Weeks 22, 24, and 26)

ID	Title	Description
OG000	Placebo	Participants received placebo orally once daily for 52 weeks.
OG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 52 in eGFR

eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.

Full analysis set with available data

Posted

Mean

Standard Deviation

mL/min/1.73 m²

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants received placebo orally once daily for 52 weeks.
OG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to the EAP in Corrected Total Calcium

Full analysis set

Posted

Mean

Standard Deviation

mg/dL

Baseline and the EAP (mean of Weeks 22, 24, and 26)

ID	Title	Description
OG000	Placebo	Participants received placebo orally once daily for 52 weeks.
OG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)

Full analysis set

Posted

Mean

Standard Deviation

pg/mL

Baseline and the EAP (mean of Weeks 22, 24, and 26)

ID	Title	Description
OG000	Placebo	Participants received placebo orally once daily for 52 weeks.
OG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to the EAP in Urine Phosphorus

Full analysis set with available data

Posted

Mean

Standard Deviation

mg/dL

Baseline and the EAP (mean of Weeks 22, 24, and 26)

ID	Title	Description
OG000	Placebo	Participants received placebo orally once daily for 52 weeks.
OG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With a Parathyroidectomy

Full analysis set

Posted

Number

percentage of participants

56 weeks

ID	Title	Description
OG000	Placebo	Participants received placebo orally once daily for 52 weeks.
OG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.

Units	Counts
Participants	OG000

Secondary

Time to Parathyroidectomy

Full analysis set who underwent a parathyroidectomy

Posted

56 weeks

ID	Title	Description
OG000	Placebo	Participants received placebo orally once daily for 52 weeks.
OG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Bradycardia	Cardiac disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Glaucoma	Eye disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Colitis	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Influenza like illness	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Pyrexia	General disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0011 affected57 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Transplant rejection	Immune system disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Cystitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0012 affected57 at risk
Escherichia sepsis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Gastroenteritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0011 affected57 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Lung infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Muscle abscess	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Osteomyelitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Pneumonia	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Pyelonephritis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0011 affected57 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0011 affected57 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Urostomy complication	Injury, poisoning and procedural complications	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Proteinuria	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Renal impairment	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0011 affected57 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk
Intermittent claudication	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0010 affected57 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected57 at risk EG0011 affected57 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected57 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0005 affected57 at risk EG0012 affected57 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected57 at risk EG0018 affected57 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0006 affected57 at risk EG0017 affected57 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment	EG0004 affected57 at risk EG0013 affected57 at risk
Fatigue	General disorders	MedDRA 16.0	Systematic Assessment	EG0007 affected57 at risk EG0016 affected57 at risk
Influenza like illness	General disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected57 at risk EG0010 affected57 at risk
Malaise	General disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0014 affected57 at risk
Oedema peripheral	General disorders	MedDRA 16.0	Systematic Assessment	EG0008 affected57 at risk EG0016 affected57 at risk
Nasopharyngitis	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0008 affected57 at risk EG0017 affected57 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0002 affected57 at risk EG0015 affected57 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.0	Systematic Assessment	EG0006 affected57 at risk EG0018 affected57 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected57 at risk EG0012 affected57 at risk
Gout	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0013 affected57 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected57 at risk EG0014 affected57 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected57 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0014 affected57 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0015 affected57 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected57 at risk EG0013 affected57 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected57 at risk EG0015 affected57 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected57 at risk EG0011 affected57 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected57 at risk EG0011 affected57 at risk
Headache	Nervous system disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected57 at risk EG0015 affected57 at risk
Insomnia	Psychiatric disorders	MedDRA 16.0	Systematic Assessment	EG0001 affected57 at risk EG0013 affected57 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected57 at risk EG0018 affected57 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0004 affected57 at risk EG0013 affected57 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	Systematic Assessment	EG0000 affected57 at risk EG0013 affected57 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected57 at risk EG0011 affected57 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.0	Systematic Assessment	EG0003 affected57 at risk EG0010 affected57 at risk
Hypertension	Vascular disorders	MedDRA 16.0	Systematic Assessment	EG0002 affected57 at risk EG0015 affected57 at risk

ID	Term
D051436	Renal Insufficiency, Chronic
D007676	Kidney Failure, Chronic
D006961	Hyperparathyroidism
D017674	Hypophosphatemia
D007674	Kidney Diseases
D006934	Hypercalcemia

ID	Term
D051437	Renal Insufficiency
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
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D002128	Calcium Metabolism Disorders
D014883	Water-Electrolyte Imbalance

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Placebo	Participants received placebo orally once daily for 52 weeks.
BG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
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 orally once daily for 52 weeks.			19	57	45	57
EG001	Cinacalcet	Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.			15	57	45	57