Trial Outcomes & Findings for Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab (NCT NCT02275156)

Last Updated: 2022-11-07

Results Overview

Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 800 ng/mL.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose

Results posted on

2022-11-07

Participant Flow

Eighteen participants were enrolled at 1 center in the United States. The first participant enrolled on 19 August 2014 and the last participant enrolled on 28 October 2014.

Participant milestones

Participant milestones
Measure	Normal Renal Function Participants with normal renal function (defined as an estimated glomerular filtration rate \[eGFR\] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Severe Renal Impairment Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	End Stage Renal Disease Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
Overall Study STARTED	6	6	6
Overall Study COMPLETED	6	6	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Renal Function n=6 Participants Participants with normal renal function (defined as an estimated glomerular filtration rate \[eGFR\] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	End Stage Renal Disease n=6 Participants Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Total n=18 Participants Total of all reporting groups
Age, Continuous	51.2 years STANDARD_DEVIATION 9.9 • n=5 Participants	63.3 years STANDARD_DEVIATION 7.8 • n=7 Participants	57.0 years STANDARD_DEVIATION 8.1 • n=5 Participants	57.2 years STANDARD_DEVIATION 9.6 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized Black (or African American)	1 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants	6 participants n=4 Participants
Race/Ethnicity, Customized White	5 participants n=5 Participants	5 participants n=7 Participants	2 participants n=5 Participants	12 participants n=4 Participants

PRIMARY outcome

Timeframe: Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose

Population: Pharmacokinetic (PK) analysis set (all participants for whom at least 1 PK parameter could be adequately estimated)

Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 800 ng/mL.

Outcome measures

Outcome measures
Measure	Normal Renal Function n=6 Participants Participants with normal renal function (defined as an estimated glomerular filtration rate \[eGFR\] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	End Stage Renal Disease n=6 Participants Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
Maximum Observed Serum Concentration (Cmax) of Evolocumab	21.3 μg/mL Standard Deviation 9.00	15.1 μg/mL Standard Deviation 8.86	11.7 μg/mL Standard Deviation 7.20

PRIMARY outcome

Timeframe: Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose

Population: PK analysis set

Outcome measures

Outcome measures
Measure	Normal Renal Function n=6 Participants Participants with normal renal function (defined as an estimated glomerular filtration rate \[eGFR\] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	End Stage Renal Disease n=6 Participants Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) for Evolocumab	185 day*μg/mL Standard Deviation 92.5	141 day*μg/mL Standard Deviation 109	102 day*μg/mL Standard Deviation 80.1

SECONDARY outcome

Timeframe: From the first dose of study drug up until Day 57

Population: Safety analysis set (all participants who received at least 1 dose of study drug)

The severity of each adverse event was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: * fatal; * life threatening (places the participant at immediate risk of death); * requires in patient hospitalization or prolongation of existing hospitalization; * results in persistent or significant disability/incapacity; * congenital anomaly/birth defect; * other medically important serious event. The investigator assessed whether each adverse event was possibly related to the study drug.

Outcome measures

Outcome measures
Measure	Normal Renal Function n=6 Participants Participants with normal renal function (defined as an estimated glomerular filtration rate \[eGFR\] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	End Stage Renal Disease n=6 Participants Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
Number of Participants With Adverse Events Leading to discontinuation from study	0 participants	0 participants	0 participants
Number of Participants With Adverse Events Fatal adverse events	0 participants	0 participants	0 participants
Number of Participants With Adverse Events Treatment-related adverse events	0 participants	0 participants	0 participants
Number of Participants With Adverse Events Any adverse event	1 participants	1 participants	2 participants
Number of Participants With Adverse Events Grade ≥ 2	1 participants	1 participants	0 participants
Number of Participants With Adverse Events Grade ≥ 3	0 participants	1 participants	0 participants
Number of Participants With Adverse Events Grade ≥ 4	0 participants	0 participants	0 participants
Number of Participants With Adverse Events Serious adverse events	0 participants	1 participants	0 participants
Number of Participants With Adverse Events Leading to discontinuation of study drug	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 57 days

Population: Safety analysis set

The investigator reviewed vital signs and laboratory test results and determined whether an abnormal value in an individual participant represented a clinically significant change from the participant's baseline values.

Outcome measures

Outcome measures
Measure	Normal Renal Function n=6 Participants Participants with normal renal function (defined as an estimated glomerular filtration rate \[eGFR\] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	End Stage Renal Disease n=6 Participants Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
Number of Participants With Clinically Relevant Vital Sign or Clinical Laboratory Changes	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 57 days

Population: Safety analysis set

Blood samples were tested using an electrochemiluminescence-based bridging immunoassay to detect antibodies capable of binding to evolocumab.

Outcome measures

Outcome measures
Measure	Normal Renal Function n=6 Participants Participants with normal renal function (defined as an estimated glomerular filtration rate \[eGFR\] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	End Stage Renal Disease n=6 Participants Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
Number of Participants With Anti-evolocumab Antibodies	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose

Population: Safety analysis set

The derived log-transformed AUECday1-57 for direct LDL-C was analyzed using a mixed-effect analysis of variance model. Log-transformed baseline LDL-C was the covariate.

Outcome measures

Outcome measures
Measure	Normal Renal Function n=6 Participants Participants with normal renal function (defined as an estimated glomerular filtration rate \[eGFR\] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	End Stage Renal Disease n=6 Participants Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
Area Under the Effect Curve From Baseline to Day 57 (AUECday1-57) for Low-density Lipoprotein Cholesterol (LDL-C)	4438.6 mg/dL*day Interval 3873.3 to 5086.5	4087.5 mg/dL*day Interval 3555.5 to 4699.1	4620.2 mg/dL*day Interval 4050.8 to 5269.6

SECONDARY outcome

Timeframe: Baseline and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose

Population: Safety analysis set

Serum PCSK9 concentrations were determined using a qualified ELISA. The LLOQ of the assay was 15 ng/mL. Log-transformed baseline PCSK9 was included in the model as a covariate and participant as a random effect.

Outcome measures

Outcome measures
Measure	Normal Renal Function n=6 Participants Participants with normal renal function (defined as an estimated glomerular filtration rate \[eGFR\] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Severe Renal Impairment n=6 Participants Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	End Stage Renal Disease n=6 Participants Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 1, Hour 4	-91.69 percent change Interval -94.66 to -87.09	-79.20 percent change Interval -86.63 to -67.64	-72.95 percent change Interval -82.59 to -57.97
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 2	-96.67 percent change Interval -97.86 to -94.83	-95.87 percent change Interval -97.34 to -93.57	-94.41 percent change Interval -96.4 to -91.31
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 3	-96.67 percent change Interval -97.86 to -94.83	-96.33 percent change Interval -97.64 to -94.29	-95.58 percent change Interval -97.16 to -93.14
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 4	-96.67 percent change Interval -97.86 to -94.83	-96.33 percent change Interval -97.64 to -94.29	-96.53 percent change Interval -97.77 to -94.61
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 6	-96.67 percent change Interval -97.86 to -94.83	-96.33 percent change Interval -97.64 to -94.29	-95.39 percent change Interval -97.03 to -92.83
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 8	-96.67 percent change Interval -97.86 to -94.83	-96.33 percent change Interval -97.64 to -94.29	-95.01 percent change Interval -96.79 to -92.25
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 11	-96.67 percent change Interval -97.86 to -94.83	-95.96 percent change Interval -97.4 to -93.71	-94.69 percent change Interval -96.58 to -91.75
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 15	-90.42 percent change Interval -93.84 to -85.12	-86.41 percent change Interval -91.26 to -78.86	-82.97 percent change Interval -89.04 to -73.53
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 22	-65.84 percent change Interval -78.02 to -46.4	-57.92 percent change Interval -72.95 to -34.54	-60.33 percent change Interval -74.47 to -38.36
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 29	-49.12 percent change Interval -67.26 to -20.93	-53.66 percent change Interval -70.21 to -27.91	-51.88 percent change Interval -69.03 to -25.23
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 43	-24.93 percent change Interval -51.7 to 16.67	-36.30 percent change Interval -59.05 to -0.92	-42.44 percent change Interval -62.95 to -10.56
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 50	-2.88 percent change Interval -37.51 to 50.95	-26.57 percent change Interval -52.79 to 14.22	-37.04 percent change Interval -59.48 to -2.17
Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Day 57	-1.46 percent change Interval -36.6 to 53.14	-14.49 percent change Interval -45.03 to 33.02	-37.74 percent change Interval -59.93 to -3.25

Adverse Events

Evolocumab 140 mg - Normal Renal Function

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Evolocumab 140 mg - Severe RI

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Evolocumab 140 mg - ESRD Requiring Hemodialysis

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Evolocumab 140 mg - Total

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Evolocumab 140 mg - Normal Renal Function n=6 participants at risk Participants with normal renal function (defined as an estimated glomerular filtration rate \[eGFR\] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Evolocumab 140 mg - Severe RI n=6 participants at risk Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Evolocumab 140 mg - ESRD Requiring Hemodialysis n=6 participants at risk Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Evolocumab 140 mg - Total n=18 participants at risk Participants received a single 140 mg dose of evolocumab subcutaneously on Day 1.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	16.7% 1/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	5.6% 1/18 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.

Other adverse events

Other adverse events
Measure	Evolocumab 140 mg - Normal Renal Function n=6 participants at risk Participants with normal renal function (defined as an estimated glomerular filtration rate \[eGFR\] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Evolocumab 140 mg - Severe RI n=6 participants at risk Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Evolocumab 140 mg - ESRD Requiring Hemodialysis n=6 participants at risk Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.	Evolocumab 140 mg - Total n=18 participants at risk Participants received a single 140 mg dose of evolocumab subcutaneously on Day 1.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	16.7% 1/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	5.6% 1/18 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.
Gastrointestinal disorders Vomiting	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	16.7% 1/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	5.6% 1/18 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.
Infections and infestations Tooth infection	16.7% 1/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	5.6% 1/18 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	16.7% 1/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	5.6% 1/18 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	16.7% 1/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	5.6% 1/18 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.
Skin and subcutaneous tissue disorders Dermatitis	16.7% 1/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	0.00% 0/6 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.	5.6% 1/18 • From the first dose of study drug up until Day 57 Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold. Summary of Adverse Events includes only those subjects who received at least one dose of investigational product. ESRD = End stage renal disease requiring dialysis.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER