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Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00975000
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : January 29, 2016
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Allograft Nephropathy
Chronic Kidney Disease
Chronic Renal Failure
Disordered Mineral Metabolism
End Stage Renal Disease
Hyperparathyroidism
Hypophosphatemia
Kidney Disease
Kidney Transplantation
Post Renal Transplantation
Interventions Drug: Cinacalcet
Drug: Placebo
Enrollment 114
Recruitment Details

This study was conducted at 33 centers in 11 countries (Australia, Austria, Belgium, Canada, France, Germany, Italy, Poland, Spain, Switzerland, and USA).

First patient enrolled on 15 October 2009 and last patient enrolled on 07 March 2012.

Pre-assignment Details The study consisted of a 20-week titration phase, a 6-week efficacy assessment phase (EAP), a 26-week blinded maintenance phase and a 4-week follow-up phase. Randomization was stratified by corrected total serum calcium (Ca); enrollment into the low Ca stratum was limited to ≤70% of patients to ensure at least 30% enrollment in the high Ca stratum.
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description Participants received placebo orally once daily for 52 weeks. 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.
Period Title: Overall Study
Started 57 57
Completed Titration Phase 54 55
Completed Efficacy Assessment Phase 54 54
Completed Maintenance Phase 52 52
Completed 52 [1] 52 [1]
Not Completed 5 5
Reason Not Completed
Other             1             0
Adverse Event             1             1
Withdrawal by Subject             2             2
Lost to Follow-up             0             1
Protocol-specified Criteria             1             0
Non-compliance             0             1
[1]
Completed post-treatment follow-up phase
Arm/Group Title Placebo Cinacalcet Total
Hide Arm/Group Description Participants received placebo orally once daily for 52 weeks. 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. Total of all reporting groups
Overall Number of Baseline Participants 57 57 114
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 57 participants 114 participants
51.7  (9.9) 53.0  (10.7) 52.3  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
Female
25
  43.9%
26
  45.6%
51
  44.7%
Male
32
  56.1%
31
  54.4%
63
  55.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
White or Caucasian 46 47 93
Black or African American 4 5 9
Hispanic or Latino 1 2 3
Asian 3 2 5
Native Hawaiian or Other Pacific Islander 2 0 2
Other 1 1 2
Stratification Factor: Albumin-corrected Calcium Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
Corrected calcium ≤ 11.2 mg/dL 22 23 45
Corrected calcium > 11.2 mg/dL 35 34 69
Corrected Total Serum Calcium  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 57 participants 57 participants 114 participants
11.31  (0.50) 11.28  (0.41) 11.29  (0.45)
Intact Parathyroid Hormone  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 57 participants 57 participants 114 participants
307.5  (180.5) 327.7  (262.6) 317.6  (224.5)
Serum Phosphorus   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 57 participants 57 participants 114 participants
2.48  (0.52) 2.66  (0.54) 2.57  (0.54)
[1]
Measure Description: Data available for 56 participants in each treatment group.
Estimated Glomerular Filtration Rate (eGFR)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73 m²
Number Analyzed 57 participants 57 participants 114 participants
54.68  (14.79) 57.00  (17.31) 55.84  (16.07)
[1]
Measure Description: eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
1.Primary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame Weeks 21 to 26 (EAP)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all randomized participants excluding participants determined to have graft failure prior to week 26)
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received placebo orally once daily for 52 weeks.
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.
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Unit of Measure: percentage of participants
3.5 78.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments The primary endpoint was tested at a significance level of 0.05.
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 Cochran-Mantel-Haenszel (CMH) test stratified by baseline corrected total serum calcium level (≤ 11.2 mg/dL and > 11.2 mg/dL)
Method of Estimation Estimation Parameter Chi-Square test statistic
Estimated Value 66.437
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 91.41
Confidence Interval (2-Sided) 95%
18.76 to 445.41
Estimation Comments Odds ratio of Cinacalcet/Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 75.44
Confidence Interval (2-Sided) 95%
63.83 to 87.05
Estimation Comments Difference = Cinacalcet-Placebo
2.Secondary Outcome
Title Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck
Hide Description Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received placebo orally once daily for 52 weeks.
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.
Overall Number of Participants Analyzed 49 52
Median (Inter-Quartile Range)
Unit of Measure: percent change
1.05
(-1.80 to 3.51)
1.24
(-1.52 to 4.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.266
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.
Method of Estimation Estimation Parameter Difference
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
-1.10 to 3.93
Estimation Comments Least square estimate for the difference in the percent change in BMD between the 2 treatment groups (cinacalcet – placebo)
3.Secondary Outcome
Title Change From Baseline to the EAP in Mean Serum Phosphorus
Hide Description [Not Specified]
Time Frame Baseline and the EAP (mean of Weeks 22, 24, and 26)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received placebo orally once daily for 52 weeks.
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.
Overall Number of Participants Analyzed 56 56
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.07  (0.48) 0.52  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
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 ANCOVA
Comments Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.
Method of Estimation Estimation Parameter Difference
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.26 to 0.64
Estimation Comments Least square estimate for the difference in the absolute change in mean serum phosphorus between the 2 treatment groups (cinacalcet – placebo)
4.Secondary Outcome
Title Change From Baseline to Week 52 in eGFR
Hide Description eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Time Frame Baseline and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received placebo orally once daily for 52 weeks.
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.
Overall Number of Participants Analyzed 52 51
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73 m²
0.06  (8.70) -0.37  (11.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.842
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with Baseline corrected total serum calcium group as a covariate.
Method of Estimation Estimation Parameter Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-4.37 to 3.57
Estimation Comments Least square estimate for the difference in the absolute change in mean eGFR between the 2 treatment groups (cinacalcet – placebo)
5.Secondary Outcome
Title Change From Baseline to the EAP in Corrected Total Calcium
Hide Description [Not Specified]
Time Frame Baseline and the EAP (mean of Weeks 22, 24, and 26)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received placebo orally once daily for 52 weeks.
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.
Overall Number of Participants Analyzed 57 57
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.14  (0.51) -1.53  (0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
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 ANCOVA
Comments ANCOVA with Baseline corrected total serum calcium group as a covariate.
Method of Estimation Estimation Parameter Difference
Estimated Value -1.39
Confidence Interval (2-Sided) 95%
-1.62 to -1.16
Estimation Comments Least square estimate for the difference in the absolute change in corrected total calcium between the 2 treatment groups (cinacalcet – placebo)
6.Secondary Outcome
Title Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)
Hide Description [Not Specified]
Time Frame Baseline and the EAP (mean of Weeks 22, 24, and 26)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received placebo orally once daily for 52 weeks.
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.
Overall Number of Participants Analyzed 57 57
Mean (Standard Deviation)
Unit of Measure: pg/mL
-10.6  (106.4) -127.9  (254.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with Baseline corrected total serum calcium group as a covariate.
Method of Estimation Estimation Parameter Difference
Estimated Value -117.21
Confidence Interval (2-Sided) 95%
-189.88 to -44.55
Estimation Comments Least square estimate for the difference in the absolute change in iPTH between the 2 treatment groups (cinacalcet – placebo)
7.Secondary Outcome
Title Change From Baseline to the EAP in Urine Phosphorus
Hide Description [Not Specified]
Time Frame Baseline and the EAP (mean of Weeks 22, 24, and 26)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received placebo orally once daily for 52 weeks.
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.
Overall Number of Participants Analyzed 56 53
Mean (Standard Deviation)
Unit of Measure: mg/dL
-1.47  (31.51) -2.62  (43.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.846
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with Baseline corrected total serum calcium group as a covariate.
Method of Estimation Estimation Parameter Difference
Estimated Value -1.42
Confidence Interval (2-Sided) 95%
-15.91 to 13.06
Estimation Comments Least square estimate for the difference in the absolute change in urine phosphorus between the 2 treatment groups (cinacalcet – placebo)
8.Secondary Outcome
Title Percentage of Participants With a Parathyroidectomy
Hide Description [Not Specified]
Time Frame 56 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received placebo orally once daily for 52 weeks.
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.
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0
9.Secondary Outcome
Title Time to Parathyroidectomy
Hide Description [Not Specified]
Time Frame 56 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set who underwent a parathyroidectomy
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description:
Participants received placebo orally once daily for 52 weeks.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 60 Weeks
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Placebo Cinacalcet
Hide Arm/Group Description Participants received placebo orally once daily for 52 weeks. 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.
All-Cause Mortality
Placebo Cinacalcet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Cinacalcet
Affected / at Risk (%) Affected / at Risk (%)
Total   19/57 (33.33%)   15/57 (26.32%) 
Blood and lymphatic system disorders     
Anaemia  1  0/57 (0.00%)  1/57 (1.75%) 
Neutropenia  1  1/57 (1.75%)  0/57 (0.00%) 
Cardiac disorders     
Bradycardia  1  1/57 (1.75%)  0/57 (0.00%) 
Eye disorders     
Glaucoma  1  0/57 (0.00%)  1/57 (1.75%) 
Gastrointestinal disorders     
Abdominal hernia  1  0/57 (0.00%)  1/57 (1.75%) 
Abdominal pain upper  1  0/57 (0.00%)  1/57 (1.75%) 
Colitis  1  1/57 (1.75%)  0/57 (0.00%) 
Diarrhoea  1  0/57 (0.00%)  1/57 (1.75%) 
Gastrooesophageal reflux disease  1  1/57 (1.75%)  0/57 (0.00%) 
Haematochezia  1  1/57 (1.75%)  0/57 (0.00%) 
Inguinal hernia  1  0/57 (0.00%)  1/57 (1.75%) 
Intestinal obstruction  1  1/57 (1.75%)  0/57 (0.00%) 
Pancreatitis acute  1  0/57 (0.00%)  1/57 (1.75%) 
General disorders     
Influenza like illness  1  0/57 (0.00%)  1/57 (1.75%) 
Pyrexia  1  1/57 (1.75%)  1/57 (1.75%) 
Hepatobiliary disorders     
Cholecystitis  1  1/57 (1.75%)  0/57 (0.00%) 
Immune system disorders     
Kidney transplant rejection  1  0/57 (0.00%)  1/57 (1.75%) 
Transplant rejection  1  1/57 (1.75%)  0/57 (0.00%) 
Infections and infestations     
Cystitis  1  0/57 (0.00%)  1/57 (1.75%) 
Cytomegalovirus infection  1  1/57 (1.75%)  2/57 (3.51%) 
Escherichia sepsis  1  1/57 (1.75%)  0/57 (0.00%) 
Escherichia urinary tract infection  1  1/57 (1.75%)  0/57 (0.00%) 
Gastroenteritis  1  1/57 (1.75%)  1/57 (1.75%) 
Gastroenteritis viral  1  0/57 (0.00%)  1/57 (1.75%) 
Lung infection  1  0/57 (0.00%)  1/57 (1.75%) 
Muscle abscess  1  1/57 (1.75%)  0/57 (0.00%) 
Osteomyelitis  1  1/57 (1.75%)  0/57 (0.00%) 
Pneumonia  1  0/57 (0.00%)  1/57 (1.75%) 
Pyelonephritis  1  1/57 (1.75%)  1/57 (1.75%) 
Upper respiratory tract infection  1  1/57 (1.75%)  0/57 (0.00%) 
Urinary tract infection  1  1/57 (1.75%)  1/57 (1.75%) 
Injury, poisoning and procedural complications     
Complications of transplanted kidney  1  1/57 (1.75%)  0/57 (0.00%) 
Femoral neck fracture  1  1/57 (1.75%)  0/57 (0.00%) 
Foot fracture  1  0/57 (0.00%)  1/57 (1.75%) 
Urostomy complication  1  1/57 (1.75%)  0/57 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/57 (1.75%)  0/57 (0.00%) 
Hyperglycaemia  1  1/57 (1.75%)  0/57 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoporotic fracture  1  1/57 (1.75%)  0/57 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Clear cell renal cell carcinoma  1  1/57 (1.75%)  0/57 (0.00%) 
Lung adenocarcinoma metastatic  1  0/57 (0.00%)  1/57 (1.75%) 
Nervous system disorders     
Cerebrovascular accident  1  0/57 (0.00%)  1/57 (1.75%) 
Transient ischaemic attack  1  1/57 (1.75%)  0/57 (0.00%) 
Renal and urinary disorders     
Proteinuria  1  1/57 (1.75%)  0/57 (0.00%) 
Renal impairment  1  0/57 (0.00%)  1/57 (1.75%) 
Ureteric stenosis  1  1/57 (1.75%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Lung infiltration  1  0/57 (0.00%)  1/57 (1.75%) 
Skin and subcutaneous tissue disorders     
Diabetic foot  1  1/57 (1.75%)  0/57 (0.00%) 
Vascular disorders     
Intermittent claudication  1  1/57 (1.75%)  0/57 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Cinacalcet
Affected / at Risk (%) Affected / at Risk (%)
Total   45/57 (78.95%)   45/57 (78.95%) 
Blood and lymphatic system disorders     
Anaemia  1  3/57 (5.26%)  1/57 (1.75%) 
Gastrointestinal disorders     
Abdominal discomfort  1  2/57 (3.51%)  3/57 (5.26%) 
Abdominal pain  1  5/57 (8.77%)  2/57 (3.51%) 
Diarrhoea  1  3/57 (5.26%)  8/57 (14.04%) 
Nausea  1  6/57 (10.53%)  7/57 (12.28%) 
Vomiting  1  4/57 (7.02%)  3/57 (5.26%) 
General disorders     
Fatigue  1  7/57 (12.28%)  6/57 (10.53%) 
Influenza like illness  1  3/57 (5.26%)  0/57 (0.00%) 
Malaise  1  0/57 (0.00%)  4/57 (7.02%) 
Oedema peripheral  1  8/57 (14.04%)  6/57 (10.53%) 
Infections and infestations     
Nasopharyngitis  1  8/57 (14.04%)  7/57 (12.28%) 
Upper respiratory tract infection  1  2/57 (3.51%)  5/57 (8.77%) 
Urinary tract infection  1  6/57 (10.53%)  8/57 (14.04%) 
Metabolism and nutrition disorders     
Decreased appetite  1  3/57 (5.26%)  2/57 (3.51%) 
Gout  1  0/57 (0.00%)  3/57 (5.26%) 
Hypercholesterolaemia  1  2/57 (3.51%)  4/57 (7.02%) 
Hyperlipidaemia  1  2/57 (3.51%)  3/57 (5.26%) 
Hypokalaemia  1  0/57 (0.00%)  4/57 (7.02%) 
Hypomagnesaemia  1  1/57 (1.75%)  5/57 (8.77%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/57 (3.51%)  3/57 (5.26%) 
Back pain  1  3/57 (5.26%)  5/57 (8.77%) 
Musculoskeletal pain  1  3/57 (5.26%)  1/57 (1.75%) 
Osteoporosis  1  3/57 (5.26%)  1/57 (1.75%) 
Nervous system disorders     
Headache  1  3/57 (5.26%)  5/57 (8.77%) 
Psychiatric disorders     
Insomnia  1  1/57 (1.75%)  3/57 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/57 (5.26%)  8/57 (14.04%) 
Dyspnoea  1  4/57 (7.02%)  3/57 (5.26%) 
Oropharyngeal pain  1  0/57 (0.00%)  3/57 (5.26%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  3/57 (5.26%)  1/57 (1.75%) 
Rash  1  3/57 (5.26%)  0/57 (0.00%) 
Vascular disorders     
Hypertension  1  2/57 (3.51%)  5/57 (8.77%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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 multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00975000     History of Changes
Other Study ID Numbers: 20062007
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: December 23, 2015
Results First Posted: January 29, 2016
Last Update Posted: October 17, 2018