Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01181531
• Collaborator: (none)
• Enrollment: 312
• Arms: 2
• Actual Duration (Months): 22.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism, Secondary	Drug: Traditional Vitamin D Therapy; Drug: Cinacalcet	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 312 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Open Label Study to Compare the Efficacy of Cinacalcet Versus Traditional Vitamin D Therapy for Management of Secondary Hyperparathyroidism Among Subjects Undergoing Hemodialysis
• Actual Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jul 17, 2012
• Actual Study Completion Date: Aug 14, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Traditional Vitamin D Therapy	Drug: Traditional Vitamin D Therapy; Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT) in this study will be administered according to strategies that have been used in clinical practice and that conform to current therapeutic recommendations and available clinical practice guidelines and product labeling.
Experimental: Cinacalcet	Drug: Cinacalcet; Subjects randomized to treatment with cinacalcet will receive an initial oral dose of 30 mg once daily. Doses will be titrated incrementally to 60, 90,120, and 180 mg per day based upon periodic measurements of serum calcium and plasma PTH levels. Cinacalcet is formulated as light green tablets in 30, 60, and 90 mg free-based equivalents. Tablets will be 30, 60, and 90 mg, graduated in size, smallest to largest. Combinations of these 3 fixed dosage formulations will be used to achieve the 120 and 180 mg daily doses.

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP) [Baseline to week 40-52]

   Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52

Secondary Outcome Measures

1. Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP) [Baseline to week 40-52]

   Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)

2. Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP) [week 40-52]

   Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 18 years at screening

• Treated with maintenance hemodialysis 3 times a week for ≥ 3 months prior to screening

• Informed consent provided by the study candidate

• For subjects NOT receiving cinacalcet and/or vitamin D therapy for SHPT within 60 days prior to enrollment: Plasma PTH levels ≥ 450 pg/mL (50 pmol/L) during screening, as obtained from the central laboratory and, Serum corrected total calcium ≥ 8.4 mg/dL (2.1 mmol/L) and < 10.2 mg/dL (2.55 mmol/L) during screening, as obtained from the central laboratory

Exclusion Criteria:

• Parathyroidectomy in the 12 weeks before the date of informed consent

• History of seizure within 12 weeks prior to randomization

• Scheduled for kidney transplant

• Parathyroidectomy anticipated within the next 6 months

• Liver function tests > than 2 x the Upper Limit of Normal

• Prior use of bisphosphonates, or expected to receive bisphosphonates during the trial

• Subject has previously enrolled in this study

• General

• Other investigational procedures are excluded

• Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)

• Subject (male or female) is not willing to use highly effective contraception during treatment and for at least one month (women) and 3 months (men) after the end of treatment

• Subject is pregnant or breast feeding, or planning to become pregnant during study or within 1 month after the end of treatment Male subject with a pregnant partner who is not willing to use a condom during treatment and for at least 1 month after the end of treatment

• Subject has known sensitivity or intolerance to any of the protocol required therapies

• Subject will not be available for protocol-required study visits, to the best of the subject and investigator's knowledge

• Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

• Wetmore JB, Gurevich K, Sprague S, Da Roza G, Buerkert J, Reiner M, Goodman W, Cooper K. A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM). Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1031-40. doi: 10.2215/CJN.07050714. Epub 2015 Apr 22.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT01181531
• Other Study ID Numbers: 20090686; PARADIGM
• First Posted: Aug 13, 2010
• Last Update Posted: Oct 17, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by Amgen: Secondary Hyperthyroidism; Hemodialysis; Parathyroid; PARADIGM
• Additional relevant MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary; Vitamin D; Cinacalcet

Study Results

Participant Flow

Recruitment Details	Participants were enrolled from 08 September 2010 through 14 August 2012 Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.

Arm/Group Title	Traditional Vitamin D	Cinacalcet
Arm/Group Description	Vitamin D sterol, intravenous (IV) or oral	Cinacalcet Hydrochloride (Sensipar)
Period Title: Overall Study
STARTED	157	155
Received Investigational Product	155	153
COMPLETED	96	102
NOT COMPLETED	61	53

Baseline Characteristics

Arm/Group Title	Traditional Vitamin D	Cinacalcet	Total
Arm/Group Description	Vitamin D sterol, intravenous (IV) or oral	Cinacalcet Hydrochloride (Sensipar)	Total of all reporting groups
Overall Participants	157	155	312
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.3 (13.9)	53.5 (14.5)	53.9 (14.2)
Sex: Female, Male (Count of Participants)
Female	62 39.5%	62 40%	124 39.7%
Male	95 60.5%	93 60%	188 60.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	47 29.9%	32 20.6%	79 25.3%
Not Hispanic or Latino	110 70.1%	123 79.4%	233 74.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	1 0.6%	0 0%	1 0.3%
Asian	4 2.5%	8 5.2%	12 3.8%
Native Hawaiian or Other Pacific Islander	1 0.6%	0 0%	1 0.3%
Black or African American	60 38.2%	76 49%	136 43.6%
White	86 54.8%	66 42.6%	152 48.7%
More than one race	4 2.5%	5 3.2%	9 2.9%
Unknown or Not Reported	1 0.6%	0 0%	1 0.3%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
Description	Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52
Time Frame	Baseline to week 40-52

Outcome Measure Data

Analysis Population Description

All subjects randomized by treatment arm.

Arm/Group Title	Traditional Vitamin D	Cinacalcet
Arm/Group Description	Vitamin D sterol, intravenous (IV) or oral	Cinacalcet Hydrochloride
Measure Participants	157	155
Least Squares Mean (Standard Error) [Percent change]	-7 (4.0)	-12.1 (4.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Traditional Vitamin D, Cinacalcet
	Comments	Null hypothesis: no difference in % change from baseline in PTH comparing the two treatment arms.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.346
	Comments	Unadjusted. Model contains baseline stratification factor for type of Vitamin D administered at the site
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -15.4 to 5.4
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.3
	Estimation Comments	Cinacalcet - Vitamin D

2. Secondary Outcome

Title	Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)
Description	Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
Time Frame	Baseline to week 40-52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Traditional Vitamin D	Cinacalcet
Arm/Group Description	Vitamin D sterol, intravenous (IV) or oral	Cinacalcet Hydrochloride
Measure Participants	157	155
Yes	53 33.8%	66 42.6%
No	104 66.2%	89 57.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Traditional Vitamin D, Cinacalcet
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.110
	Comments	Stratified by type of Vitamin D at site
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.45
	Confidence Interval	(2-Sided) 95%; 0.92 to 2.29
	Parameter Dispersion	Type: Value:
	Estimation Comments	OR is Cinacalcet: Vitamin D

3. Secondary Outcome

Title	Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)
Description	Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)
Time Frame	week 40-52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Traditional Vitamin D	Cinacalcet
Arm/Group Description	Vitamin D sterol, intravenous (IV) or oral	Cinacalcet Hydrochloride
Measure Participants	157	155
Yes	24 15.3%	30 19.4%
No	133 84.7%	125 80.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Traditional Vitamin D, Cinacalcet
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.346
	Comments	stratified by type of Vitamin D at site
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.33
	Confidence Interval	(2-Sided) 95%; 0.74 to 2.39
	Parameter Dispersion	Type: Value:
	Estimation Comments	OR is Cinacalcet: Vitamin D

Adverse Events

Time Frame	56 weeks
Adverse Event Reporting Description	The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Arm/Group Title	Traditional Vitamin D		Cinacalcet
Arm/Group Description	Vitamin D sterol, intravenous (IV) or oral		Cinacalcet Hydrochloride (Sensipar)
All Cause Mortality
	Traditional Vitamin D		Cinacalcet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Traditional Vitamin D		Cinacalcet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	68/155 (43.9%)		60/153 (39.2%)
Blood and lymphatic system disorders
Anaemia	1/155 (0.6%)		1/153 (0.7%)
Cardiac disorders
Acute coronary syndrome	0/155 (0%)		1/153 (0.7%)
Acute myocardial infarction	2/155 (1.3%)		3/153 (2%)
Angina pectoris	2/155 (1.3%)		0/153 (0%)
Arrhythmia	0/155 (0%)		1/153 (0.7%)
Atrial fibrillation	3/155 (1.9%)		2/153 (1.3%)
Atrial flutter	1/155 (0.6%)		0/153 (0%)
Atrioventricular block	0/155 (0%)		1/153 (0.7%)
Atrioventricular block complete	1/155 (0.6%)		0/153 (0%)
Atrioventricular block second degree	1/155 (0.6%)		0/153 (0%)
Bradycardia	0/155 (0%)		1/153 (0.7%)
Cardiac arrest	2/155 (1.3%)		2/153 (1.3%)
Cardiac discomfort	0/155 (0%)		1/153 (0.7%)
Cardiac failure	1/155 (0.6%)		0/153 (0%)
Cardiac failure congestive	4/155 (2.6%)		3/153 (2%)
Cardio-respiratory arrest	0/155 (0%)		1/153 (0.7%)
Coronary artery disease	0/155 (0%)		1/153 (0.7%)
Myocardial infarction	0/155 (0%)		2/153 (1.3%)
Nodal arrhythmia	0/155 (0%)		1/153 (0.7%)
Supraventricular tachycardia	1/155 (0.6%)		0/153 (0%)
Ventricular fibrillation	0/155 (0%)		1/153 (0.7%)
Ventricular tachycardia	1/155 (0.6%)		0/153 (0%)
Eye disorders
Vitreous haemorrhage	1/155 (0.6%)		0/153 (0%)
Gastrointestinal disorders
Abdominal pain upper	0/155 (0%)		1/153 (0.7%)
Ascites	0/155 (0%)		1/153 (0.7%)
Colonic polyp	0/155 (0%)		1/153 (0.7%)
Diabetic gastroparesis	0/155 (0%)		1/153 (0.7%)
Diarrhoea	0/155 (0%)		1/153 (0.7%)
Diverticulum intestinal haemorrhagic	1/155 (0.6%)		0/153 (0%)
Duodenal ulcer	0/155 (0%)		1/153 (0.7%)
Duodenal ulcer haemorrhage	1/155 (0.6%)		0/153 (0%)
Gastritis	1/155 (0.6%)		2/153 (1.3%)
Gastritis haemorrhagic	0/155 (0%)		1/153 (0.7%)
Gastrointestinal haemorrhage	1/155 (0.6%)		0/153 (0%)
Gastrointestinal inflammation	0/155 (0%)		1/153 (0.7%)
Haemorrhoidal haemorrhage	0/155 (0%)		1/153 (0.7%)
Ileus paralytic	1/155 (0.6%)		0/153 (0%)
Impaired gastric emptying	1/155 (0.6%)		2/153 (1.3%)
Intestinal ischaemia	0/155 (0%)		1/153 (0.7%)
Intestinal obstruction	1/155 (0.6%)		1/153 (0.7%)
Lower gastrointestinal haemorrhage	0/155 (0%)		1/153 (0.7%)
Mallory-Weiss syndrome	0/155 (0%)		1/153 (0.7%)
Nausea	0/155 (0%)		2/153 (1.3%)
Pancreatitis	0/155 (0%)		1/153 (0.7%)
Pancreatitis chronic	1/155 (0.6%)		1/153 (0.7%)
Upper gastrointestinal haemorrhage	1/155 (0.6%)		1/153 (0.7%)
Vomiting	0/155 (0%)		1/153 (0.7%)
General disorders
Chest pain	0/155 (0%)		3/153 (2%)
Chills	0/155 (0%)		1/153 (0.7%)
Death	2/155 (1.3%)		1/153 (0.7%)
Non-cardiac chest pain	1/155 (0.6%)		4/153 (2.6%)
Oedema peripheral	0/155 (0%)		1/153 (0.7%)
Pyrexia	0/155 (0%)		1/153 (0.7%)
Sudden cardiac death	0/155 (0%)		1/153 (0.7%)
Sudden death	0/155 (0%)		1/153 (0.7%)
Thrombosis in device	0/155 (0%)		1/153 (0.7%)
Hepatobiliary disorders
Cholecystitis	0/155 (0%)		2/153 (1.3%)
Cholecystitis acute	0/155 (0%)		1/153 (0.7%)
Cholecystitis chronic	0/155 (0%)		1/153 (0.7%)
Cholelithiasis	0/155 (0%)		1/153 (0.7%)
Infections and infestations
Acute tonsillitis	0/155 (0%)		1/153 (0.7%)
Arteriovenous fistula site infection	2/155 (1.3%)		1/153 (0.7%)
Arteriovenous graft site infection	0/155 (0%)		1/153 (0.7%)
Bronchitis	3/155 (1.9%)		1/153 (0.7%)
Cellulitis	2/155 (1.3%)		0/153 (0%)
Device related infection	1/155 (0.6%)		0/153 (0%)
Device related sepsis	1/155 (0.6%)		1/153 (0.7%)
Diabetic gangrene	1/155 (0.6%)		0/153 (0%)
Gangrene	2/155 (1.3%)		1/153 (0.7%)
Gastroenteritis	1/155 (0.6%)		0/153 (0%)
Intervertebral discitis	0/155 (0%)		1/153 (0.7%)
Labyrinthitis	0/155 (0%)		1/153 (0.7%)
Lobar pneumonia	1/155 (0.6%)		0/153 (0%)
Localised infection	1/155 (0.6%)		0/153 (0%)
Osteomyelitis	1/155 (0.6%)		0/153 (0%)
Pneumonia	7/155 (4.5%)		2/153 (1.3%)
Sepsis	2/155 (1.3%)		3/153 (2%)
Sepsis syndrome	0/155 (0%)		1/153 (0.7%)
Septic shock	1/155 (0.6%)		0/153 (0%)
Staphylococcal bacteraemia	1/155 (0.6%)		2/153 (1.3%)
Staphylococcal sepsis	1/155 (0.6%)		1/153 (0.7%)
Urinary tract infection pseudomonal	1/155 (0.6%)		0/153 (0%)
Urosepsis	1/155 (0.6%)		0/153 (0%)
Wound infection	0/155 (0%)		1/153 (0.7%)
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion	2/155 (1.3%)		0/153 (0%)
Arteriovenous fistula site complication	1/155 (0.6%)		0/153 (0%)
Arteriovenous fistula thrombosis	4/155 (2.6%)		1/153 (0.7%)
Arteriovenous graft aneurysm	0/155 (0%)		1/153 (0.7%)
Arteriovenous graft site haemorrhage	0/155 (0%)		1/153 (0.7%)
Arthropod sting	0/155 (0%)		1/153 (0.7%)
Cervical vertebral fracture	1/155 (0.6%)		0/153 (0%)
Hand fracture	1/155 (0.6%)		1/153 (0.7%)
Lower limb fracture	1/155 (0.6%)		0/153 (0%)
Pelvic fracture	1/155 (0.6%)		0/153 (0%)
Post procedural haemorrhage	0/155 (0%)		1/153 (0.7%)
Rib fracture	0/155 (0%)		1/153 (0.7%)
Upper limb fracture	1/155 (0.6%)		0/153 (0%)
Vascular access complication	2/155 (1.3%)		0/153 (0%)
Vascular pseudoaneurysm	1/155 (0.6%)		0/153 (0%)
Investigations
Haemoglobin decreased	1/155 (0.6%)		0/153 (0%)
Hepatic enzyme increased	0/155 (0%)		1/153 (0.7%)
Metabolism and nutrition disorders
Diabetic ketoacidosis	0/155 (0%)		2/153 (1.3%)
Fluid overload	5/155 (3.2%)		7/153 (4.6%)
Hyperkalaemia	1/155 (0.6%)		5/153 (3.3%)
Hypocalcaemia	0/155 (0%)		1/153 (0.7%)
Hypoglycaemia	2/155 (1.3%)		2/153 (1.3%)
Hypophosphataemia	0/155 (0%)		1/153 (0.7%)
Hypovolaemia	0/155 (0%)		1/153 (0.7%)
Musculoskeletal and connective tissue disorders
Muscle haemorrhage	0/155 (0%)		1/153 (0.7%)
Musculoskeletal chest pain	0/155 (0%)		1/153 (0.7%)
Musculoskeletal pain	0/155 (0%)		1/153 (0.7%)
Osteoarthritis	0/155 (0%)		1/153 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	0/155 (0%)		1/153 (0.7%)
Endometrial cancer metastatic	0/155 (0%)		1/153 (0.7%)
Renal cell carcinoma	0/155 (0%)		1/153 (0.7%)
Uterine leiomyoma	1/155 (0.6%)		0/153 (0%)
Nervous system disorders
Ataxia	1/155 (0.6%)		0/153 (0%)
Cerebrovascular accident	1/155 (0.6%)		0/153 (0%)
Convulsion	1/155 (0.6%)		0/153 (0%)
Hemiparesis	0/155 (0%)		1/153 (0.7%)
Hypertensive encephalopathy	1/155 (0.6%)		1/153 (0.7%)
Hypoaesthesia	1/155 (0.6%)		0/153 (0%)
Intracranial aneurysm	1/155 (0.6%)		0/153 (0%)
Presyncope	1/155 (0.6%)		0/153 (0%)
Syncope	0/155 (0%)		2/153 (1.3%)
Toxic encephalopathy	1/155 (0.6%)		0/153 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/155 (0%)		1/153 (0.7%)
Renal and urinary disorders
Azotaemia	1/155 (0.6%)		0/153 (0%)
Renal failure chronic	1/155 (0.6%)		0/153 (0%)
Renal mass	0/155 (0%)		1/153 (0.7%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/155 (0.6%)		0/153 (0%)
Asthma	0/155 (0%)		1/153 (0.7%)
Chronic obstructive pulmonary disease	2/155 (1.3%)		1/153 (0.7%)
Dyspnoea	3/155 (1.9%)		3/153 (2%)
Pleural effusion	1/155 (0.6%)		0/153 (0%)
Pleuritic pain	0/155 (0%)		1/153 (0.7%)
Pneumonia aspiration	1/155 (0.6%)		1/153 (0.7%)
Pulmonary embolism	2/155 (1.3%)		0/153 (0%)
Pulmonary oedema	3/155 (1.9%)		1/153 (0.7%)
Respiratory depression	0/155 (0%)		1/153 (0.7%)
Respiratory distress	1/155 (0.6%)		0/153 (0%)
Skin and subcutaneous tissue disorders
Skin ulcer	1/155 (0.6%)		0/153 (0%)
Surgical and medical procedures
Abdominal hernia repair	1/155 (0.6%)		0/153 (0%)
Vascular disorders
Deep vein thrombosis	0/155 (0%)		1/153 (0.7%)
Hypertension	0/155 (0%)		1/153 (0.7%)
Hypertensive crisis	1/155 (0.6%)		0/153 (0%)
Hypertensive emergency	0/155 (0%)		2/153 (1.3%)
Hypotension	1/155 (0.6%)		3/153 (2%)
Ischaemic limb pain	1/155 (0.6%)		0/153 (0%)
Peripheral ischaemia	2/155 (1.3%)		0/153 (0%)
Superior vena cava syndrome	0/155 (0%)		1/153 (0.7%)
Other (Not Including Serious) Adverse Events
	Traditional Vitamin D		Cinacalcet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	83/155 (53.5%)		98/153 (64.1%)
Blood and lymphatic system disorders
Anaemia	5/155 (3.2%)		4/153 (2.6%)
Endocrine disorders
Hyperparathyroidism	5/155 (3.2%)		2/153 (1.3%)
Gastrointestinal disorders
Abdominal pain	1/155 (0.6%)		5/153 (3.3%)
Constipation	7/155 (4.5%)		8/153 (5.2%)
Diarrhoea	16/155 (10.3%)		15/153 (9.8%)
Nausea	10/155 (6.5%)		27/153 (17.6%)
Vomiting	5/155 (3.2%)		16/153 (10.5%)
General disorders
Asthenia	1/155 (0.6%)		7/153 (4.6%)
Chest pain	5/155 (3.2%)		6/153 (3.9%)
Oedema	5/155 (3.2%)		2/153 (1.3%)
Oedema peripheral	5/155 (3.2%)		8/153 (5.2%)
Pain	2/155 (1.3%)		6/153 (3.9%)
Pyrexia	8/155 (5.2%)		3/153 (2%)
Infections and infestations
Urinary tract infection	3/155 (1.9%)		5/153 (3.3%)
Injury, poisoning and procedural complications
Arteriovenous fistula site complication	7/155 (4.5%)		8/153 (5.2%)
Fall	4/155 (2.6%)		7/153 (4.6%)
Procedural hypotension	7/155 (4.5%)		4/153 (2.6%)
Vascular graft thrombosis	4/155 (2.6%)		6/153 (3.9%)
Metabolism and nutrition disorders
Decreased appetite	5/155 (3.2%)		3/153 (2%)
Fluid overload	8/155 (5.2%)		2/153 (1.3%)
Hypercalcaemia	7/155 (4.5%)		1/153 (0.7%)
Hyperkalaemia	4/155 (2.6%)		6/153 (3.9%)
Hyperphosphataemia	7/155 (4.5%)		3/153 (2%)
Hypocalcaemia	2/155 (1.3%)		26/153 (17%)
Musculoskeletal and connective tissue disorders
Arthralgia	7/155 (4.5%)		6/153 (3.9%)
Back pain	7/155 (4.5%)		3/153 (2%)
Muscle spasms	14/155 (9%)		12/153 (7.8%)
Pain in extremity	6/155 (3.9%)		10/153 (6.5%)
Nervous system disorders
Dizziness	5/155 (3.2%)		7/153 (4.6%)
Headache	4/155 (2.6%)		8/153 (5.2%)
Psychiatric disorders
Anxiety	8/155 (5.2%)		4/153 (2.6%)
Insomnia	6/155 (3.9%)		8/153 (5.2%)
Respiratory, thoracic and mediastinal disorders
Cough	10/155 (6.5%)		9/153 (5.9%)
Dyspnoea	8/155 (5.2%)		17/153 (11.1%)
Vascular disorders
Hypertension	7/155 (4.5%)		8/153 (5.2%)
Hypotension	6/155 (3.9%)		9/153 (5.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.