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ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00379899
Recruitment Status : Completed
First Posted : September 25, 2006
Results First Posted : October 27, 2010
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease
End Stage Renal Disease
Coronary Artery Calcification
Vascular Calcification
Calcification
Cardiovascular Disease
Chronic Renal Failure
Hyperparathyroidism
Kidney Disease
Nephrology
Secondary Hyperparathyroidism
Intervention Drug: cinacalcet
Enrollment 360
Recruitment Details Participants were enrolled from 27 October 2006 through 2 May 2008
Pre-assignment Details  
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description Cinacalcet plus low dose vitamin D Flexible vitamin D dosing
Period Title: Overall Study
Started 180 180
Completed 140 140
Not Completed 40 40
Reason Not Completed
Adverse Event             7             3
Death             10             10
Lost to Follow-up             2             4
Physician Decision             3             4
Withdrawal by Subject             5             5
Ineligibility determined             0             1
Noncompliance             1             1
Parathyroidectomy             0             2
Renal transplantation             5             4
Coronary artery bypass graft             1             1
Other protocol-specified criteria             3             4
Other             3             1
Arm/Group Title Cinacalcet Control Total
Hide Arm/Group Description Cinacalcet plus low dose vitamin D Flexible vitamin D dosing Total of all reporting groups
Overall Number of Baseline Participants 180 180 360
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 180 participants 360 participants
61.2  (12.6) 61.8  (12.8) 61.5  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
Female
68
  37.8%
85
  47.2%
153
  42.5%
Male
112
  62.2%
95
  52.8%
207
  57.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
American Indian or Alaska Native 1 0 1
Asian 4 6 10
Black or African American 45 40 85
Hispanic or Latino 11 14 25
Native Hawaiian or Other Pacific Islander 2 0 2
White or Caucasian 116 120 236
Other 1 0 1
Coronary Artery Calcification Score Stratification Factor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
≥30 to 399 67 67 134
≥400 to 999 47 47 94
≥1000 66 66 132
1.Primary Outcome
Title Percent Change From Baseline in CAC Score
Hide Description Percent Change from baseline to week 52 in coronary artery calcification (CAC) score. CAC score ranges from 0 to 7500, with 0 representing no calcification.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Mean (Standard Error)
Unit of Measure: Units on a scale
43.74  (7.40) 57.39  (7.77)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for screening total coronary artery calcification score stratification factor (≥ 30 to 399, ≥ 400 to 999, and ≥ 1000)
2.Secondary Outcome
Title Number of Participants Achieving > 15% Progression of CAC.
Hide Description Number of participants achieving >15% progression of coronary artery calcification (CAC) at week 52
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Measure Type: Number
Unit of Measure: Participants
63 77
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.62
Confidence Interval 95%
0.36 to 1.08
Estimation Comments Logit estimates (Cinacalcet:Control)
3.Secondary Outcome
Title Absolute Change in PTH
Hide Description Absolute change from baseline in intact Parathyroid Hormone (iPTH)
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Mean (Standard Error)
Unit of Measure: pg/mL
-132.86  (29.46) -71.55  (30.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for screening total coronary artery calcification score stratification factor
4.Secondary Outcome
Title Change From Baseline in AC Score
Hide Description Change from baseline in aortic calcification (AC) score at week 52. AC score ranges from 0 to >75,000, with 0 representing no calcification.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Mean (Standard Error)
Unit of Measure: Units on a scale
935.92  (233.81) 1677.28  (385.39)
5.Secondary Outcome
Title Change From Baseline of the Progression of AVC.
Hide Description Change from baseline in the aortic valve calcification (AVC) score. AVC score ranges from 0 to >10,000, with 0 representing no calcification.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Mean (Standard Error)
Unit of Measure: Units on a scale
24.29  (24.19) 55.96  (18.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.258
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Percent Change in PTH
Hide Description Percent change from baseline in intact Parathyroid Hormone (iPTH)
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Mean (Standard Error)
Unit of Measure: Percentage
-18.18  (5.53) -3.88  (5.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for screening total coronary artery calcification score stratification factor
7.Secondary Outcome
Title Absolute Change in Calcium
Hide Description Absolute change from baseline in serum calcium to weeks 44 through 52
Time Frame Baseline and Weeks 44 through 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Mean (Standard Error)
Unit of Measure: mg/dL
-0.51  (0.07) 0.17  (0.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for screening total coronary artery calcification score stratification factor
8.Secondary Outcome
Title Percent Change in Calcium
Hide Description Percent change from baseline in corrected serum calcium to weeks 44 through 52
Time Frame Baseline and Weeks 44 through 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Mean (Standard Error)
Unit of Measure: Percentage
-5.24  (0.72) 1.98  (0.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for screening total coronary artery calcification score stratification factor
9.Secondary Outcome
Title Absolute Change in Phosphorus
Hide Description Absolute change from baseline in serum phosphorus to weeks 44 through 52
Time Frame Baseline and Weeks 44 through 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Mean (Standard Error)
Unit of Measure: mg/dL
-0.92  (0.18) -0.24  (0.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for screening total coronary artery calcification score stratification factor
10.Secondary Outcome
Title Percent Change in Phosphorus
Hide Description Percent change from baseline in serum phosphorus to weeks 44 through 52
Time Frame Baseline and Weeks 44 through 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Mean (Standard Error)
Unit of Measure: Percentage
-9.63  (2.93) 5.26  (5.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for screening total coronary artery calcification score stratification factor
11.Secondary Outcome
Title Absolute Change in Ca x P
Hide Description Absolute change from baseline in corrected serum calcium x phosphorus to week 44 through week 52
Time Frame Baseline and Weeks 44 through 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Mean (Standard Error)
Unit of Measure: (mg/dL)2
-11.22  (1.68) -1.32  (1.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for screening total coronary artery calcification score stratification factor
12.Secondary Outcome
Title Percent Change in Ca x P
Hide Description Percent change from baseline in corrected serum calcium x phosphorus (Ca x P) to weeks 44 through 52
Time Frame Baseline and Weeks 44 through 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set, composed of all randomized participants with a baseline and a week 52 coronary artery calcification score
Arm/Group Title Cinacalcet Control
Hide Arm/Group Description:
Cinacalcet plus low dose vitamin D
Flexible vitamin D dosing
Overall Number of Participants Analyzed 115 120
Mean (Standard Error)
Unit of Measure: Percentage
-14.56  (2.88) 6.54  (5.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cinacalcet, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Adjusted for screening total coronary artery calcification score stratification factor
Time Frame 52 weeks
Adverse Event Reporting Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
 
Arm/Group Title Cinacalcet Control Group
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Cinacalcet Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cinacalcet Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   88/180 (48.89%)   82/180 (45.56%) 
Blood and lymphatic system disorders     
Anaemia  1  7/180 (3.89%)  3/180 (1.67%) 
Febrile neutropenia  1  0/180 (0.00%)  1/180 (0.56%) 
Hypoprothrombinaemia  1  1/180 (0.56%)  0/180 (0.00%) 
Nephrogenic anaemia  1  1/180 (0.56%)  0/180 (0.00%) 
Thrombocytopenia  1  0/180 (0.00%)  1/180 (0.56%) 
Cardiac disorders     
Acute coronary syndrome  1  1/180 (0.56%)  1/180 (0.56%) 
Acute myocardial infarction  1  4/180 (2.22%)  3/180 (1.67%) 
Angina pectoris  1  7/180 (3.89%)  4/180 (2.22%) 
Arrhythmia  1  0/180 (0.00%)  1/180 (0.56%) 
Atrial fibrillation  1  1/180 (0.56%)  3/180 (1.67%) 
Bradyarrhythmia  1  0/180 (0.00%)  1/180 (0.56%) 
Cardiac failure  1  2/180 (1.11%)  0/180 (0.00%) 
Cardiac failure acute  1  1/180 (0.56%)  0/180 (0.00%) 
Cardiac failure chronic  1  1/180 (0.56%)  0/180 (0.00%) 
Cardiac failure congestive  1  6/180 (3.33%)  2/180 (1.11%) 
Cardiomyopathy  1  0/180 (0.00%)  1/180 (0.56%) 
Coronary artery disease  1  2/180 (1.11%)  1/180 (0.56%) 
Ischaemic cardiomyopathy  1  1/180 (0.56%)  0/180 (0.00%) 
Mitral valve incompetence  1  1/180 (0.56%)  0/180 (0.00%) 
Myocardial infarction  1  2/180 (1.11%)  2/180 (1.11%) 
Myocardial ischaemia  1  1/180 (0.56%)  2/180 (1.11%) 
Pericardial effusion  1  2/180 (1.11%)  0/180 (0.00%) 
Supraventricular tachycardia  1  1/180 (0.56%)  0/180 (0.00%) 
Tachycardia  1  0/180 (0.00%)  1/180 (0.56%) 
Ventricular arrhythmia  1  0/180 (0.00%)  1/180 (0.56%) 
Congenital, familial and genetic disorders     
Congenital cystic kidney disease  1  1/180 (0.56%)  0/180 (0.00%) 
Familial mediterranean fever  1  1/180 (0.56%)  0/180 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/180 (0.56%)  0/180 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  1/180 (0.56%)  0/180 (0.00%) 
Hyperparathyroidism  1  0/180 (0.00%)  1/180 (0.56%) 
Hyperparathyroidism secondary  1  1/180 (0.56%)  0/180 (0.00%) 
Eye disorders     
Diabetic retinopathy  1  0/180 (0.00%)  1/180 (0.56%) 
Eye pain  1  0/180 (0.00%)  1/180 (0.56%) 
Glaucoma  1  0/180 (0.00%)  1/180 (0.56%) 
Gastrointestinal disorders     
Abdominal distension  1  1/180 (0.56%)  0/180 (0.00%) 
Abdominal pain  1  3/180 (1.67%)  2/180 (1.11%) 
Abdominal wall haematoma  1  0/180 (0.00%)  1/180 (0.56%) 
Anal polyp  1  0/180 (0.00%)  1/180 (0.56%) 
Ascites  1  1/180 (0.56%)  1/180 (0.56%) 
Colitis ischaemic  1  1/180 (0.56%)  0/180 (0.00%) 
Constipation  1  1/180 (0.56%)  1/180 (0.56%) 
Crohn's disease  1  0/180 (0.00%)  1/180 (0.56%) 
Diarrhoea  1  1/180 (0.56%)  3/180 (1.67%) 
Diverticulum  1  0/180 (0.00%)  1/180 (0.56%) 
Duodenal ulcer  1  0/180 (0.00%)  1/180 (0.56%) 
Gastritis  1  3/180 (1.67%)  1/180 (0.56%) 
Gastrointestinal haemorrhage  1  1/180 (0.56%)  2/180 (1.11%) 
Gingival bleeding  1  1/180 (0.56%)  0/180 (0.00%) 
Haematochezia  1  0/180 (0.00%)  1/180 (0.56%) 
Haemorrhagic ascites  1  1/180 (0.56%)  0/180 (0.00%) 
Ileus  1  1/180 (0.56%)  0/180 (0.00%) 
Impaired gastric emptying  1  1/180 (0.56%)  0/180 (0.00%) 
Intestinal infarction  1  1/180 (0.56%)  0/180 (0.00%) 
Large intestine perforation  1  1/180 (0.56%)  0/180 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/180 (0.56%)  0/180 (0.00%) 
Melaena  1  1/180 (0.56%)  0/180 (0.00%) 
Nausea  1  4/180 (2.22%)  0/180 (0.00%) 
Oesophagitis  1  1/180 (0.56%)  0/180 (0.00%) 
Periodontal disease  1  1/180 (0.56%)  0/180 (0.00%) 
Proctalgia  1  1/180 (0.56%)  0/180 (0.00%) 
Rectal haemorrhage  1  1/180 (0.56%)  0/180 (0.00%) 
Umbilical hernia  1  1/180 (0.56%)  0/180 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/180 (0.56%)  2/180 (1.11%) 
Vomiting  1  2/180 (1.11%)  0/180 (0.00%) 
General disorders     
Asthenia  1  3/180 (1.67%)  1/180 (0.56%) 
Catheter related complication  1  1/180 (0.56%)  0/180 (0.00%) 
Catheter thrombosis  1  2/180 (1.11%)  0/180 (0.00%) 
Chest pain  1  1/180 (0.56%)  1/180 (0.56%) 
Chills  1  1/180 (0.56%)  1/180 (0.56%) 
Drug intolerance  1  1/180 (0.56%)  0/180 (0.00%) 
Multi-organ failure  1  0/180 (0.00%)  1/180 (0.56%) 
Non-cardiac chest pain  1  2/180 (1.11%)  2/180 (1.11%) 
Oedema peripheral  1  1/180 (0.56%)  0/180 (0.00%) 
Pyrexia  1  5/180 (2.78%)  4/180 (2.22%) 
Sudden cardiac death  1  0/180 (0.00%)  2/180 (1.11%) 
Hepatobiliary disorders     
Bile duct stone  1  0/180 (0.00%)  1/180 (0.56%) 
Biliary cyst  1  0/180 (0.00%)  1/180 (0.56%) 
Biliary dilatation  1  1/180 (0.56%)  0/180 (0.00%) 
Cholecystitis  1  1/180 (0.56%)  1/180 (0.56%) 
Cholelithiasis  1  1/180 (0.56%)  1/180 (0.56%) 
Hepatic cirrhosis  1  0/180 (0.00%)  1/180 (0.56%) 
Jaundice  1  1/180 (0.56%)  0/180 (0.00%) 
Immune system disorders     
Hypersensitivity  1  1/180 (0.56%)  0/180 (0.00%) 
Kidney transplant rejection  1  1/180 (0.56%)  0/180 (0.00%) 
Transplant rejection  1  0/180 (0.00%)  1/180 (0.56%) 
Infections and infestations     
Abdominal abscess  1  1/180 (0.56%)  0/180 (0.00%) 
Abdominal wall abscess  1  1/180 (0.56%)  0/180 (0.00%) 
Abscess  1  0/180 (0.00%)  1/180 (0.56%) 
Abscess limb  1  1/180 (0.56%)  0/180 (0.00%) 
Abscess neck  1  1/180 (0.56%)  0/180 (0.00%) 
Arteriovenous fistula site infection  1  3/180 (1.67%)  0/180 (0.00%) 
Bacterial infection  1  1/180 (0.56%)  0/180 (0.00%) 
Bacterial sepsis  1  3/180 (1.67%)  1/180 (0.56%) 
Bone abscess  1  1/180 (0.56%)  0/180 (0.00%) 
Bronchiectasis  1  1/180 (0.56%)  0/180 (0.00%) 
Bronchitis  1  2/180 (1.11%)  2/180 (1.11%) 
Catheter related infection  1  1/180 (0.56%)  0/180 (0.00%) 
Catheter sepsis  1  2/180 (1.11%)  1/180 (0.56%) 
Cellulitis  1  2/180 (1.11%)  0/180 (0.00%) 
Central line infection  1  0/180 (0.00%)  1/180 (0.56%) 
Clostridium difficile colitis  1  1/180 (0.56%)  0/180 (0.00%) 
Diverticulitis  1  0/180 (0.00%)  1/180 (0.56%) 
Endocarditis  1  2/180 (1.11%)  0/180 (0.00%) 
Enterococcal sepsis  1  1/180 (0.56%)  0/180 (0.00%) 
Enterocolitis infectious  1  0/180 (0.00%)  1/180 (0.56%) 
Enterocolitis viral  1  0/180 (0.00%)  1/180 (0.56%) 
Erysipelas  1  0/180 (0.00%)  1/180 (0.56%) 
Escherichia bacteraemia  1  0/180 (0.00%)  2/180 (1.11%) 
Gangrene  1  3/180 (1.67%)  1/180 (0.56%) 
Gastroenteritis  1  1/180 (0.56%)  1/180 (0.56%) 
Gastroenteritis clostridial  1  1/180 (0.56%)  0/180 (0.00%) 
Graft infection  1  0/180 (0.00%)  1/180 (0.56%) 
Hepatitis C  1  0/180 (0.00%)  1/180 (0.56%) 
Lobar pneumonia  1  2/180 (1.11%)  2/180 (1.11%) 
Localised infection  1  2/180 (1.11%)  0/180 (0.00%) 
Osteomyelitis  1  0/180 (0.00%)  1/180 (0.56%) 
Peritoneal candidiasis  1  1/180 (0.56%)  0/180 (0.00%) 
Peritonitis bacterial  1  1/180 (0.56%)  0/180 (0.00%) 
Pneumonia  1  3/180 (1.67%)  7/180 (3.89%) 
Pneumonia primary atypical  1  1/180 (0.56%)  0/180 (0.00%) 
Postoperative wound infection  1  0/180 (0.00%)  1/180 (0.56%) 
Respiratory tract infection  1  1/180 (0.56%)  0/180 (0.00%) 
Scrotal abscess  1  1/180 (0.56%)  0/180 (0.00%) 
Sepsis  1  5/180 (2.78%)  4/180 (2.22%) 
Staphylococcal bacteraemia  1  0/180 (0.00%)  1/180 (0.56%) 
Staphylococcal infection  1  0/180 (0.00%)  1/180 (0.56%) 
Staphylococcal osteomyelitis  1  1/180 (0.56%)  0/180 (0.00%) 
Staphylococcal sepsis  1  0/180 (0.00%)  1/180 (0.56%) 
Subcutaneous abscess  1  0/180 (0.00%)  1/180 (0.56%) 
Urinary tract infection  1  1/180 (0.56%)  0/180 (0.00%) 
Urosepsis  1  1/180 (0.56%)  0/180 (0.00%) 
Viral infection  1  0/180 (0.00%)  1/180 (0.56%) 
Wound infection staphylococcal  1  1/180 (0.56%)  0/180 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/180 (0.00%)  1/180 (0.56%) 
Arteriovenous fistula aneurysm  1  1/180 (0.56%)  1/180 (0.56%) 
Arteriovenous fistula site complication  1  1/180 (0.56%)  1/180 (0.56%) 
Arteriovenous fistula site haemorrhage  1  0/180 (0.00%)  1/180 (0.56%) 
Arteriovenous fistula thrombosis  1  6/180 (3.33%)  3/180 (1.67%) 
Arteriovenous graft thrombosis  1  0/180 (0.00%)  1/180 (0.56%) 
Complications of transplanted kidney  1  1/180 (0.56%)  0/180 (0.00%) 
Contusion  1  1/180 (0.56%)  0/180 (0.00%) 
Cystitis radiation  1  1/180 (0.56%)  0/180 (0.00%) 
Femur fracture  1  2/180 (1.11%)  1/180 (0.56%) 
Graft thrombosis  1  1/180 (0.56%)  0/180 (0.00%) 
Hip fracture  1  1/180 (0.56%)  1/180 (0.56%) 
Humerus fracture  1  1/180 (0.56%)  0/180 (0.00%) 
Multiple fractures  1  0/180 (0.00%)  2/180 (1.11%) 
Post procedural complication  1  1/180 (0.56%)  0/180 (0.00%) 
Post procedural haemorrhage  1  1/180 (0.56%)  0/180 (0.00%) 
Road traffic accident  1  0/180 (0.00%)  1/180 (0.56%) 
Shunt thrombosis  1  0/180 (0.00%)  1/180 (0.56%) 
Splenic rupture  1  1/180 (0.56%)  0/180 (0.00%) 
Subdural haematoma  1  0/180 (0.00%)  1/180 (0.56%) 
Vascular access complication  1  3/180 (1.67%)  1/180 (0.56%) 
Vascular graft occlusion  1  1/180 (0.56%)  0/180 (0.00%) 
Investigations     
Blood glucose increased  1  0/180 (0.00%)  1/180 (0.56%) 
Electrocardiogram ST segment depression  1  1/180 (0.56%)  0/180 (0.00%) 
Haemoglobin decreased  1  0/180 (0.00%)  1/180 (0.56%) 
Metabolism and nutrition disorders     
Cachexia  1  1/180 (0.56%)  0/180 (0.00%) 
Diabetic ketoacidosis  1  1/180 (0.56%)  0/180 (0.00%) 
Failure to thrive  1  0/180 (0.00%)  1/180 (0.56%) 
Fluid overload  1  4/180 (2.22%)  2/180 (1.11%) 
Hyperglycaemia  1  1/180 (0.56%)  1/180 (0.56%) 
Hyperkalaemia  1  6/180 (3.33%)  3/180 (1.67%) 
Hypervolaemia  1  2/180 (1.11%)  2/180 (1.11%) 
Hypocalcaemia  1  1/180 (0.56%)  0/180 (0.00%) 
Hypoglycaemia  1  4/180 (2.22%)  0/180 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/180 (0.56%)  0/180 (0.00%) 
Arthropathy  1  1/180 (0.56%)  0/180 (0.00%) 
Back pain  1  0/180 (0.00%)  1/180 (0.56%) 
Bursitis  1  0/180 (0.00%)  1/180 (0.56%) 
Fistula  1  0/180 (0.00%)  1/180 (0.56%) 
Intervertebral disc degeneration  1  0/180 (0.00%)  1/180 (0.56%) 
Mobility decreased  1  0/180 (0.00%)  1/180 (0.56%) 
Muscular weakness  1  0/180 (0.00%)  1/180 (0.56%) 
Musculoskeletal chest pain  1  0/180 (0.00%)  2/180 (1.11%) 
Pain in extremity  1  0/180 (0.00%)  1/180 (0.56%) 
Pathological fracture  1  0/180 (0.00%)  1/180 (0.56%) 
Spinal column stenosis  1  0/180 (0.00%)  1/180 (0.56%) 
Trismus  1  0/180 (0.00%)  1/180 (0.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer recurrent  1  1/180 (0.56%)  0/180 (0.00%) 
Breast cancer  1  1/180 (0.56%)  0/180 (0.00%) 
Metastases to bone  1  0/180 (0.00%)  1/180 (0.56%) 
Metastases to liver  1  0/180 (0.00%)  1/180 (0.56%) 
Ovarian cancer  1  0/180 (0.00%)  1/180 (0.56%) 
Pancreatic carcinoma  1  0/180 (0.00%)  1/180 (0.56%) 
Pancreatic neoplasm  1  0/180 (0.00%)  1/180 (0.56%) 
Renal cancer  1  0/180 (0.00%)  1/180 (0.56%) 
Renal cell carcinoma  1  1/180 (0.56%)  0/180 (0.00%) 
Renal neoplasm  1  0/180 (0.00%)  1/180 (0.56%) 
Thyroid cancer  1  0/180 (0.00%)  1/180 (0.56%) 
Nervous system disorders     
Anoxic encephalopathy  1  1/180 (0.56%)  0/180 (0.00%) 
Convulsion  1  1/180 (0.56%)  0/180 (0.00%) 
Dementia  1  0/180 (0.00%)  1/180 (0.56%) 
Disturbance in attention  1  1/180 (0.56%)  0/180 (0.00%) 
Dizziness  1  0/180 (0.00%)  1/180 (0.56%) 
Encephalopathy  1  0/180 (0.00%)  1/180 (0.56%) 
Epilepsy  1  0/180 (0.00%)  1/180 (0.56%) 
Hypertensive encephalopathy  1  0/180 (0.00%)  1/180 (0.56%) 
Hypertonia  1  1/180 (0.56%)  0/180 (0.00%) 
Ischaemic stroke  1  1/180 (0.56%)  0/180 (0.00%) 
Myoclonus  1  1/180 (0.56%)  0/180 (0.00%) 
Sciatica  1  1/180 (0.56%)  0/180 (0.00%) 
Spinal cord compression  1  1/180 (0.56%)  0/180 (0.00%) 
Syncope  1  2/180 (1.11%)  2/180 (1.11%) 
Transient ischaemic attack  1  1/180 (0.56%)  1/180 (0.56%) 
Psychiatric disorders     
Anxiety  1  0/180 (0.00%)  1/180 (0.56%) 
Depression  1  0/180 (0.00%)  2/180 (1.11%) 
Mental status changes  1  2/180 (1.11%)  3/180 (1.67%) 
Renal and urinary disorders     
Calculus urinary  1  0/180 (0.00%)  1/180 (0.56%) 
Haematuria  1  1/180 (0.56%)  0/180 (0.00%) 
Renal failure chronic  1  2/180 (1.11%)  0/180 (0.00%) 
Reproductive system and breast disorders     
Endometriosis  1  0/180 (0.00%)  1/180 (0.56%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/180 (0.56%)  0/180 (0.00%) 
Acute respiratory failure  1  0/180 (0.00%)  1/180 (0.56%) 
Asthma  1  1/180 (0.56%)  1/180 (0.56%) 
Chronic obstructive pulmonary disease  1  6/180 (3.33%)  2/180 (1.11%) 
Cough  1  1/180 (0.56%)  0/180 (0.00%) 
Dyspnoea  1  5/180 (2.78%)  4/180 (2.22%) 
Haemoptysis  1  0/180 (0.00%)  1/180 (0.56%) 
Hypoxia  1  0/180 (0.00%)  1/180 (0.56%) 
Pleural effusion  1  3/180 (1.67%)  1/180 (0.56%) 
Pulmonary oedema  1  1/180 (0.56%)  5/180 (2.78%) 
Respiratory arrest  1  0/180 (0.00%)  1/180 (0.56%) 
Respiratory failure  1  0/180 (0.00%)  1/180 (0.56%) 
Sleep apnoea syndrome  1  1/180 (0.56%)  0/180 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  0/180 (0.00%)  1/180 (0.56%) 
Decubitus ulcer  1  0/180 (0.00%)  1/180 (0.56%) 
Dry gangrene  1  0/180 (0.00%)  1/180 (0.56%) 
Surgical and medical procedures     
Arteriovenous graft  1  1/180 (0.56%)  0/180 (0.00%) 
Renal transplant  1  0/180 (0.00%)  1/180 (0.56%) 
Vascular disorders     
Aortic aneurysm  1  1/180 (0.56%)  0/180 (0.00%) 
Deep vein thrombosis  1  2/180 (1.11%)  0/180 (0.00%) 
Embolism  1  1/180 (0.56%)  0/180 (0.00%) 
Extremity necrosis  1  2/180 (1.11%)  0/180 (0.00%) 
Femoral arterial stenosis  1  1/180 (0.56%)  0/180 (0.00%) 
Haematoma  1  1/180 (0.56%)  0/180 (0.00%) 
Hypertension  1  4/180 (2.22%)  6/180 (3.33%) 
Hypertensive crisis  1  0/180 (0.00%)  2/180 (1.11%) 
Hypotension  1  3/180 (1.67%)  3/180 (1.67%) 
Labile blood pressure  1  0/180 (0.00%)  1/180 (0.56%) 
Malignant hypertension  1  1/180 (0.56%)  0/180 (0.00%) 
Orthostatic hypotension  1  1/180 (0.56%)  0/180 (0.00%) 
Peripheral ischaemia  1  2/180 (1.11%)  0/180 (0.00%) 
Peripheral vascular disorder  1  3/180 (1.67%)  0/180 (0.00%) 
Shock  1  1/180 (0.56%)  0/180 (0.00%) 
Venous stenosis  1  0/180 (0.00%)  1/180 (0.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cinacalcet Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   95/180 (52.78%)   93/180 (51.67%) 
Blood and lymphatic system disorders     
Anaemia  1  6/180 (3.33%)  13/180 (7.22%) 
Gastrointestinal disorders     
Abdominal pain  1  6/180 (3.33%)  11/180 (6.11%) 
Diarrhoea  1  29/180 (16.11%)  22/180 (12.22%) 
Nausea  1  29/180 (16.11%)  14/180 (7.78%) 
Vomiting  1  23/180 (12.78%)  22/180 (12.22%) 
General disorders     
Chest pain  1  5/180 (2.78%)  10/180 (5.56%) 
Pyrexia  1  11/180 (6.11%)  13/180 (7.22%) 
Infections and infestations     
Nasopharyngitis  1  7/180 (3.89%)  12/180 (6.67%) 
Injury, poisoning and procedural complications     
Fall  1  3/180 (1.67%)  10/180 (5.56%) 
Metabolism and nutrition disorders     
Hypocalcaemia  1  14/180 (7.78%)  1/180 (0.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/180 (2.78%)  16/180 (8.89%) 
Back pain  1  6/180 (3.33%)  11/180 (6.11%) 
Pain in extremity  1  7/180 (3.89%)  22/180 (12.22%) 
Nervous system disorders     
Dizziness  1  10/180 (5.56%)  13/180 (7.22%) 
Headache  1  13/180 (7.22%)  21/180 (11.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  18/180 (10.00%)  23/180 (12.78%) 
Dyspnoea  1  9/180 (5.00%)  17/180 (9.44%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  6/180 (3.33%)  10/180 (5.56%) 
Vascular disorders     
Hypertension  1  14/180 (7.78%)  5/180 (2.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. 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 multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00379899    
Other Study ID Numbers: 20060111
First Submitted: September 21, 2006
First Posted: September 25, 2006
Results First Submitted: October 1, 2010
Results First Posted: October 27, 2010
Last Update Posted: July 23, 2014