Study to Assess Darbepoetin Alfa Dosing for the Correctio... | NCT00436748

Label	Type	Description	Intervention Names
Darbepoetin Alfa QW	Experimental	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.	Drug: Darbepoetin Alfa
Darbepoetin Alfa Q2W	Experimental	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.	Drug: Darbepoetin Alfa Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Darbepoetin Alfa	Drug	Administered by subcutaneous or intravenous injection	Darbepoetin Alfa Q2W Darbepoetin Alfa QW

Measure	Description	Time Frame
Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL	The proportion of participants achieving hemoglobin ≥ 10.0 g/dL (the correction proportion) was calculated as the number of participants achieving a hemoglobin ≥ 10.0 g/dL at any time point during the study when administered de novo darbepoetin alfa without receiving any red blood cell transfusion after randomization and within 90 days before the achievement, divided by the number of participants in the efficacy analysis set.	24 weeks

Measure	Description	Time Frame
Time to First Hemoglobin Value ≥ 10.0 g/dL	The time from study Day 1 to the day a participant first achieved hemoglobin ≥ 10.0 g/dL for participants who achieved hemoglobin ≥ 10.0 g/dL.	24 weeks
Hemoglobin Concentration Over Time

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35233	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
28815341	Background	Warady BA, Barcia J, Benador N, Jankauskiene A, Olson K, Podracka L, Shavkin A, Srivaths P, Wong CJ, Petersen J. De novo weekly and biweekly darbepoetin alfa dosing in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2018 Jan;33(1):125-137. doi: 10.1007/s00467-017-3758-5. Epub 2017 Aug 17.
36791280	Derived

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL

The proportion of participants achieving hemoglobin ≥ 10.0 g/dL (the correction proportion) was calculated as the number of participants achieving a hemoglobin ≥ 10.0 g/dL at any time point during the study when administered de novo darbepoetin alfa without receiving any red blood cell transfusion after randomization and within 90 days before the achievement, divided by the number of participants in the efficacy analysis set.

Efficacy analysis set

Posted

Number

95% Confidence Interval

proportion of participants

24 weeks

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Units	Counts
Participants	OG00058 OG00156

Title

Denominators

Categories

Title	Measurements
	OG0000.983(0.908 to 1.000) OG0010.839(0.717 to 0.924)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	The null hypothesis for the Darbepoetin Alfa QW group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p > 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.	Exact		<0.001														Superiority or Other (legacy)
OG001

Secondary

Time to First Hemoglobin Value ≥ 10.0 g/dL

The time from study Day 1 to the day a participant first achieved hemoglobin ≥ 10.0 g/dL for participants who achieved hemoglobin ≥ 10.0 g/dL.

Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL)

Posted

Median

Inter-Quartile Range

days

24 weeks

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Hemoglobin Concentration Over Time

Efficacy analyis set with available data at each time point (indicated by "n").

Posted

Mean

Standard Deviation

g/dL

Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL

The darbepoetin alfa dose at the time a participant achieved a first hemoglobin level ≥ 10.0 g/dL, divided by the participant's weight measured at the closest study week prior to the dosing, post dialysis.

Efficacy analysis set responders (participants with at least 1 postbaseline hemoglobin ≥ 10.0 g/dL) for whom dosing data were available.

Posted

Mean

Standard Deviation

μg/kg

24 weeks

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Darbepoetin Alfa Weight-Adjusted Dose Over Time

Arithmetic means are provided; Withheld doses are counted as 0 μg.

Efficacy analyis set with available data at each time point (indicated by "n"). Numbers > 0 on non-darbepoetin alfa dosing weeks for the Q2W group reflect participants who did not receive the assigned placebo dose (eg, dose withheld per investigator decision based on hemoglobin value or missed visit).

Posted

Mean

Standard Deviation

μg/kg

Day 1 (initial dose) and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores

The PedsQL is a health-related quality of life (HRQOL) questionnaire that can be used to measure quality of life in children ≥ 2 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 2 to 4 (toddler), 5-7, 8-12, and 13-18 years are used for parent proxy-reporting, which assesses parents' perceptions of their child's HRQOL. The instructions ask how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item's score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).

Efficacy analysis set with available data for each score at each time point (indicated by "n").

Posted

Mean

Standard Error

units on a scale

Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores

The PedsQL child self-reported questionnaire was used in children > 5 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 5-7, 8-12, and 13-18 years was used for child self-reporting. The instructions asked how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale for ages 8 to 18 (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem), or simplified to a 3-point scale for ages 5 to 7 (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item's score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL).

Efficacy analysis set aged > 5 years and with available data for each score at each time point (indicated by "n").

Posted

Mean

Standard Error

units on a scale

Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Number of Participants With Treatment-emergent Adverse Events

A serious adverse event (SAE) is defined as an adverse event that meets at least one of the following serious criteria: • is fatal, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • is a congenital anomaly/birth defect, and/or • other significant medical hazard. The investigator assessed whether the adverse event was related to the investigational product (IP). Events of interest included hypertension, ischemic heart disease, cardiac failure, cerebrovascular disorders, convulsions, embolic and thrombotic events, embolic and thrombotic events: venous, embolic and thrombotic events: arterial, embolic and thrombotic events: vessel type unspecified and mixed arterial and venous, dialysis vascular access thrombosis, antibody-mediated pure red cell aplasia, hypersensitivity, lack of efficacy-effect, and malignancies.

Safety analysis set including all participants who received ≥ 1 dose of investigational product.

Posted

Number

participants

25 weeks

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Hemoglobin Serial Rate of Change (ROC) Over Time

Calculated using the serial method as the change in hemoglobin from the previous non-missing hemoglobin level divided by number of days in between, and then multiplied by 7.

Safety analyis set with available data at each time point (indicated by "n").

Posted

Median

Full Range

g/dL/week

Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study

Safety analysis set

Posted

Number

participants

25 weeks

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Units	Counts

Secondary

Maximum Increase in Hemoglobin Over Any 2 Week Period

The maximum increase between any 2 non-missing hemoglobin measurements over any 2-week period from Day 1.

Safety analysis set

Posted

Mean

Standard Deviation

g/dL/2 weeks

25 weeks

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Change From Baseline in Systolic Blood Pressure Over Time

Safety analyis set with available data at each time point (indicated by "n").

Posted

Mean

Standard Deviation

mmHg

Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Change From Baseline in Diastolic Blood Pressure Over Time

Safety analyis set with available data at each time point (indicated by "n").

Posted

Mean

Standard Deviation

mmHg

Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Number of Participants Who Developed Anti-erythropoiesis Antibodies

Participants who were negative for anti-erythropoiesis antibodies at Baseline (pre-dose) and who developed anti-erythropoiesis antibodies during the study. Serum samples were tested using Amgen's Surface Plasmon Resonance Immunoassay (SPRIA) method.

Safety analysis set with both pre and postdose immunoassay antibody results

Posted

Number

participants

25 weeks

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Secondary

Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age

Serum concentrations of darbepoetin alfa were measured by an enzyme-linked immunosorbent assay (ELISA).

Due to the low number of participants <6 years of age summary concentration analyses were not performed.

Posted

Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose

ID	Title	Description
OG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
OG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Histiocytosis haematophagic	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected58 at risk EG0011 affected56 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Device failure	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Device malfunction	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0011 affected56 at risk
Local swelling	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Medical device complication	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0011 affected56 at risk
Oedema	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0011 affected56 at risk
Appendicitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Bronchitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Catheter site infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Device related infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Device related sepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Peritonitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0012 affected56 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Pyelonephritis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Sepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Shunt infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Viral infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Arteriovenous fistula site haematoma	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Gastrostomy failure	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected58 at risk EG0010 affected56 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected58 at risk EG0010 affected56 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0011 affected56 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Renal impairment	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected58 at risk EG0010 affected56 at risk
Vesical fistula	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0011 affected56 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0013 affected56 at risk
Hypertensive crisis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected58 at risk EG0010 affected56 at risk
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0012 affected56 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected58 at risk EG0011 affected56 at risk

ID	Term
D000740	Anemia
D051436	Renal Insufficiency, Chronic
D007674	Kidney Diseases

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D051437	Renal Insufficiency
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description
BG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
BG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Darbepoetin Alfa QW	Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.			16	58	42	58
EG001	Darbepoetin Alfa Q2W	Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.			14	56	43	56