NCT00436748 is a Phase 3 clinical trial of Darbepoetin Alfa in Anemia, sponsored by Amgen.

Who is sponsoring NCT00436748?

NCT00436748 is sponsored by Amgen.

What drugs are being tested in NCT00436748?

Interventions in NCT00436748: Darbepoetin Alfa, Placebo.

What condition does NCT00436748 study?

NCT00436748 studies Anemia, Chronic Kidney Disease, Kidney Disease.

Is NCT00436748 still recruiting?

NCT00436748 is currently terminated. Last updated 29 November 2022.

Are results published for NCT00436748?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-11-29 · How we verify

NCT00436748

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease

Terminated Phase 3 Results posted Last updated 29 November 2022

What this trial tests

Phase 3 trial testing Darbepoetin Alfa in Anemia in 116 participants. Terminated before completion.

Timeline

16 September 2008

Primary endpoint
3 March 2014

3 March 2014

Quick facts

Lead sponsor	Amgen
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	116
Start date	16 September 2008
Primary completion	3 March 2014
Estimated completion	3 March 2014
Sites	67 locations across Slovakia, Russia, Belgium, United Kingdom, Poland, Mexico, Puerto Rico, Lithuania

Drugs / interventions tested

Darbepoetin Alfa (DARBEPOETIN ALFA) — full drug profile →
Placebo

Conditions studied

Anemia — all drugs for Anemia →
Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
Kidney Disease — all drugs for Kidney Disease →

Sponsor

Amgen — full company profile →

Who can join

Adults 1 to 18, any sex, with Anemia or Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL Primary · 24 weeks

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.

Group	Value	95% CI
Darbepoetin Alfa QW	0.983	0.908 – 1.000
Darbepoetin Alfa Q2W	0.839	0.717 – 0.924

Time to First Hemoglobin Value ≥ 10.0 g/dL Secondary · 24 weeks

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.

Group	Value	95% CI
Darbepoetin Alfa QW	24.0	15.0 – 50.0
Darbepoetin Alfa Q2W	22.0	14.0 – 41.0

Hemoglobin Concentration Over Time Secondary · 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.

Baseline (n=58, 56)

Group	Value	95% CI
Darbepoetin Alfa QW	8.59	± 0.84
Darbepoetin Alfa Q2W	8.73	± 0.84

Week 1 (n=53, 50)

Group	Value	95% CI
Darbepoetin Alfa QW	8.64	± 0.90
Darbepoetin Alfa Q2W	8.65	± 0.95

Week 2 (n=52, 52)

Group	Value	95% CI
Darbepoetin Alfa QW	8.74	± 1.09
Darbepoetin Alfa Q2W	8.96	± 1.20

Week 3 (n=51, 55)

Group	Value	95% CI
Darbepoetin Alfa QW	9.28	± 1.27
Darbepoetin Alfa Q2W	9.09	± 1.27

Week 4 (n=53, 53)

Group	Value	95% CI
Darbepoetin Alfa QW	9.79	± 1.30
Darbepoetin Alfa Q2W	9.55	± 1.23

Week 5 (n=53, 52)

Group	Value	95% CI
Darbepoetin Alfa QW	10.18	± 1.29
Darbepoetin Alfa Q2W	9.87	± 1.32

Week 6 (n=54, 50)

Group	Value	95% CI
Darbepoetin Alfa QW	10.54	± 1.43
Darbepoetin Alfa Q2W	10.19	± 1.33

Week 7 (n=52, 48)

Group	Value	95% CI
Darbepoetin Alfa QW	10.96	± 1.53
Darbepoetin Alfa Q2W	10.17	± 1.25

Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL Secondary · 24 weeks

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.

Group	Value	95% CI
Darbepoetin Alfa QW	0.48	± 0.24
Darbepoetin Alfa Q2W	0.76	± 0.21

Darbepoetin Alfa Weight-Adjusted Dose Over Time Secondary · 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.

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

Initial Dose (n=58, 56)

Group	Value	95% CI
Darbepoetin Alfa QW	0.45	± 0.07
Darbepoetin Alfa Q2W	0.73	± 0.13

Week 2 (n=55, 0)

Group	Value	95% CI
Darbepoetin Alfa QW	0.45	± 0.07
Darbepoetin Alfa Q2W	NA	± NA

Week 3 (n=55, 52)

Group	Value	95% CI
Darbepoetin Alfa QW	0.44	± 0.07
Darbepoetin Alfa Q2W	0.72	± 0.11

Week 4 (n=54, 0)

Group	Value	95% CI
Darbepoetin Alfa QW	0.40	± 0.11
Darbepoetin Alfa Q2W	NA	± NA

Week 5 (n=54, 51)

Group	Value	95% CI
Darbepoetin Alfa QW	0.43	± 0.26
Darbepoetin Alfa Q2W	0.72	± 0.25

Week 6 (n=54, 0)

Group	Value	95% CI
Darbepoetin Alfa QW	0.42	± 0.29
Darbepoetin Alfa Q2W	NA	± NA

Week 7 (n=54, 51)

Group	Value	95% CI
Darbepoetin Alfa QW	0.38	± 0.25
Darbepoetin Alfa Q2W	0.70	± 0.28

Week 8 (n=53, 1)

Group	Value	95% CI
Darbepoetin Alfa QW	0.34	± 0.24
Darbepoetin Alfa Q2W	0.00	± NA

Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores Secondary · Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)

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 sc

Week 13 Total Score (n=45, 46)

Group	Value	95% CI
Darbepoetin Alfa QW	4.50	± 2.19
Darbepoetin Alfa Q2W	0.58	± 2.43

Week 13 Psychosocial composite score (n=45, 46)

Group	Value	95% CI
Darbepoetin Alfa QW	5.12	± 2.16
Darbepoetin Alfa Q2W	-0.41	± 2.57

Week 13 Physical function score (n=45, 46)

Group	Value	95% CI
Darbepoetin Alfa QW	3.61	± 3.20
Darbepoetin Alfa Q2W	2.31	± 3.35

Week 13 Emotional function score (n=45, 46)

Group	Value	95% CI
Darbepoetin Alfa QW	1.00	± 3.00
Darbepoetin Alfa Q2W	-3.89	± 2.74

Week 13 Social function score (n=45, 46)

Group	Value	95% CI
Darbepoetin Alfa QW	6.89	± 3.54
Darbepoetin Alfa Q2W	0.76	± 3.56

Week 13 School function score (n=42, 42)

Group	Value	95% CI
Darbepoetin Alfa QW	7.30	± 2.47
Darbepoetin Alfa Q2W	4.17	± 3.63

Week 25 Total Score (n=38, 41)

Group	Value	95% CI
Darbepoetin Alfa QW	1.90	± 2.06
Darbepoetin Alfa Q2W	0.65	± 2.66

Week 25 Psychosocial composite score (n=38, 41)

Group	Value	95% CI
Darbepoetin Alfa QW	2.52	± 1.83
Darbepoetin Alfa Q2W	-1.84	± 3.13

Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores Secondary · Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)

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

Week 13 Total Score (n=46, 46)

Group	Value	95% CI
Darbepoetin Alfa QW	2.94	± 1.70
Darbepoetin Alfa Q2W	-1.23	± 2.04

Week 13 Psychosocial composite score (n=46, 46)

Group	Value	95% CI
Darbepoetin Alfa QW	2.59	± 1.92
Darbepoetin Alfa Q2W	-0.45	± 2.23

Week 13 Physical function score (n=46, 46)

Group	Value	95% CI
Darbepoetin Alfa QW	3.78	± 2.43
Darbepoetin Alfa Q2W	-2.79	± 2.59

Week 13 Emotional function score (n=46, 46)

Group	Value	95% CI
Darbepoetin Alfa QW	0.43	± 2.52
Darbepoetin Alfa Q2W	-0.76	± 2.79

Week 13 Social function score (n=46, 46)

Group	Value	95% CI
Darbepoetin Alfa QW	3.26	± 2.93
Darbepoetin Alfa Q2W	-2.28	± 3.02

Week 13 School function score (n=45, 43)

Group	Value	95% CI
Darbepoetin Alfa QW	2.89	± 2.98
Darbepoetin Alfa Q2W	2.44	± 3.83

Week 25 Total Score (n=40, 42)

Group	Value	95% CI
Darbepoetin Alfa QW	5.00	± 1.75
Darbepoetin Alfa Q2W	2.58	± 1.78

Week 25 Psychosocial composite score (n=40, 42)

Group	Value	95% CI
Darbepoetin Alfa QW	3.81	± 1.97
Darbepoetin Alfa Q2W	3.53	± 2.01

Number of Participants With Treatment-emergent Adverse Events Secondary · 25 weeks

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, convul

All adverse events

Group	Value	95% CI
Darbepoetin Alfa QW	48
Darbepoetin Alfa Q2W	50

Serious adverse events

Group	Value	95% CI
Darbepoetin Alfa QW	16
Darbepoetin Alfa Q2W	14

Leading to discontinuation of IP

Group	Value	95% CI
Darbepoetin Alfa QW	0
Darbepoetin Alfa Q2W	2

Leading to discontinuation from study

Group	Value	95% CI
Darbepoetin Alfa QW	0
Darbepoetin Alfa Q2W	2

Fatal adverse events

Group	Value	95% CI
Darbepoetin Alfa QW	0
Darbepoetin Alfa Q2W	0

Events of interest

Group	Value	95% CI
Darbepoetin Alfa QW	18
Darbepoetin Alfa Q2W	20

Treatment-related adverse events (TRAE)

Group	Value	95% CI
Darbepoetin Alfa QW	14
Darbepoetin Alfa Q2W	16

Treatment-related serious adverse events

Group	Value	95% CI
Darbepoetin Alfa QW	1
Darbepoetin Alfa Q2W	2

Hemoglobin Serial Rate of Change (ROC) Over Time Secondary · 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.

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.

Week 2 (n=49, 47)

Group	Value	95% CI
Darbepoetin Alfa QW	0.263	-0.90 – 1.17
Darbepoetin Alfa Q2W	0.350	-1.82 – 2.10

Week 3 (n=50, 53)

Group	Value	95% CI
Darbepoetin Alfa QW	0.530	-1.00 – 1.70
Darbepoetin Alfa Q2W	0.200	-1.23 – 1.40

Week 4 (n=53, 52)

Group	Value	95% CI
Darbepoetin Alfa QW	0.560	-0.40 – 2.20
Darbepoetin Alfa Q2W	0.513	-1.60 – 3.33

Week 5 (n=53, 49)

Group	Value	95% CI
Darbepoetin Alfa QW	0.438	-2.00 – 2.00
Darbepoetin Alfa Q2W	0.117	-3.92 – 1.52

Week 6 (n=54, 48)

Group	Value	95% CI
Darbepoetin Alfa QW	0.400	-2.50 – 2.40
Darbepoetin Alfa Q2W	0.231	-1.05 – 2.40

Week 7 (n=51, 45)

Group	Value	95% CI
Darbepoetin Alfa QW	0.200	-1.20 – 2.90
Darbepoetin Alfa Q2W	0.100	-1.75 – 2.57

Week 8 (n=52, 49)

Group	Value	95% CI
Darbepoetin Alfa QW	0.163	-1.98 – 1.63
Darbepoetin Alfa Q2W	0.300	-2.71 – 1.17

Week 9 (n=49, 50)

Group	Value	95% CI
Darbepoetin Alfa QW	0.100	-2.80 – 1.40
Darbepoetin Alfa Q2W	0.089	-1.30 – 2.20

Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study Secondary · 25 weeks

Number of participants with hemoglobin > 12.0 g/dL

Group	Value	95% CI
Darbepoetin Alfa QW	44
Darbepoetin Alfa Q2W	33

Number of participants with hemoglobin > 13.0 g/dL

Group	Value	95% CI
Darbepoetin Alfa QW	24
Darbepoetin Alfa Q2W	6

Number of participants with hemoglobin > 14.0 g/dL

Group	Value	95% CI
Darbepoetin Alfa QW	6
Darbepoetin Alfa Q2W	2

Maximum Increase in Hemoglobin Over Any 2 Week Period Secondary · 25 weeks

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

Group	Value	95% CI
Darbepoetin Alfa QW	2.06	± 0.88
Darbepoetin Alfa Q2W	1.61	± 0.76

Change From Baseline in Systolic Blood Pressure Over Time Secondary · 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.

Week 2 (n=55, 54)

Group	Value	95% CI
Darbepoetin Alfa QW	1.7	-0.90 – 1.17
Darbepoetin Alfa Q2W	-3.9	-1.82 – 2.10

Week 3 (n=55, 56)

Group	Value	95% CI
Darbepoetin Alfa QW	1.1	-1.00 – 1.70
Darbepoetin Alfa Q2W	0.0	-1.23 – 1.40

Week 4 (n=55, 54)

Group	Value	95% CI
Darbepoetin Alfa QW	1.3	-0.40 – 2.20
Darbepoetin Alfa Q2W	1.2	-1.60 – 3.33

Week 5 (n=55, 52)

Group	Value	95% CI
Darbepoetin Alfa QW	1.1	-2.00 – 2.00
Darbepoetin Alfa Q2W	-3.0	-3.92 – 1.52

Week 6 (n=54, 51)

Group	Value	95% CI
Darbepoetin Alfa QW	0.2	-2.50 – 2.40
Darbepoetin Alfa Q2W	-2.9	-1.05 – 2.40

Week 7 (n=54, 52)

Group	Value	95% CI
Darbepoetin Alfa QW	-1.0	-1.20 – 2.90
Darbepoetin Alfa Q2W	-3.7	-1.75 – 2.57

Week 8 (n=55, 52)

Group	Value	95% CI
Darbepoetin Alfa QW	0.5	-1.98 – 1.63
Darbepoetin Alfa Q2W	-2.7	-2.71 – 1.17

Week 9 (n=54, 52)

Group	Value	95% CI
Darbepoetin Alfa QW	1.0	-2.80 – 1.40
Darbepoetin Alfa Q2W	-3.1	-1.30 – 2.20

Adverse events — posted to ClinicalTrials.gov

Time frame: 25 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Darbepoetin Alfa QW

Serious: 16/58 (28%)

Deaths: —

Darbepoetin Alfa Q2W

Serious: 14/56 (25%)

Deaths: —

Serious adverse events (52 terms)

Reaction	System	Darbepoetin Alfa QW	Darbepoetin Alfa Q2W
Hyperkalaemia	Metabolism and nutrition disorders	—	—
Hypertension	Vascular disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Peritonitis	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Renal impairment	Renal and urinary disorders	—	—
Hypotension	Vascular disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Histiocytosis haematophagic	Blood and lymphatic system disorders	—	—
Tachycardia	Cardiac disorders	—	—
Tinnitus	Ear and labyrinth disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Device failure	General disorders	—	—
Device malfunction	General disorders	—	—
Local swelling	General disorders	—	—
Medical device complication	General disorders	—	—
Oedema	General disorders	—	—
Pyrexia	General disorders	—	—
Appendicitis	Infections and infestations	—	—
Bronchitis	Infections and infestations	—	—
Catheter site infection	Infections and infestations	—	—
Cellulitis	Infections and infestations	—	—
Clostridium difficile colitis	Infections and infestations	—	—
Device related infection	Infections and infestations	—	—
Device related sepsis	Infections and infestations	—	—

Other adverse events (32 terms — click to expand)

Reaction	System	Darbepoetin Alfa QW	Darbepoetin Alfa Q2W
Vomiting	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Headache	Nervous system disorders	—	—
Hypertension	Vascular disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Nausea	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Pharyngitis	Infections and infestations	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Catheter site infection	Infections and infestations	—	—
Ear infection	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Catheter site pain	General disorders	—	—
Injection site pain	General disorders	—	—
Medical device complication	General disorders	—	—
Contusion	Injury, poisoning and procedural complications	—	—
Procedural hypotension	Injury, poisoning and procedural complications	—	—
Blood pressure increased	Investigations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Hypotension	Vascular disorders	—	—

Most-reported serious reactions: Hyperkalaemia, Hypertension, Abdominal pain, Peritonitis, Headache, Renal impairment, Hypotension, Anaemia.

Data from ClinicalTrials.gov NCT00436748 adverse events section.

Sponsor's own description

The primary objectives of this study are the following: 1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and 2. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Darbepoetin for the anaemia of chronic kidney disease.
Palmer SC, Saglimbene V, Craig JC, Navaneethan SD, et al · · 2014 · cited 21× · PMID 24683046 · DOI 10.1002/14651858.cd009297.pub2
Frequency of administration of erythropoiesis-stimulating agents for the anaemia of end-stage kidney disease in dialysis patients.
Hahn D, Cody JD, Hodson EM. · · 2014 · cited 7× · PMID 24872328 · DOI 10.1002/14651858.cd003895.pub3

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00436748 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 29 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00436748.

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