Phase 3 N=4 Treatment

Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)

Anaemia

Bottom Line

View on ClinicalTrials.gov: NCT05682326 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Nov 2025

Primary outcome: Primary: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) — 2; 2; 1; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Daprodustat (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Oct 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	2; 2; 1; 0	—
PRIMARY Number of Participants With Adverse Event of Special Interests (AESIs)	0; 0	—
PRIMARY Number of Participants With AEs Leading to Study Intervention Discontinuation	0; 0	—
SECONDARY Change From Baseline in Hematology Parameter: Hematocrit	0.0160; 0.0030; 0.0530; 0.0025; -0.0280; 0.0135	—
SECONDARY Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes	0.0080; -0.0039; -0.0020; 0.0031; 0.0060; -0.0012	—
SECONDARY Change From Baseline in Hematology Parameter: Erythrocytes	0.130; 0.060; 0.480; 0.045; -0.350; 0.060	—
SECONDARY Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count	0.0120; 0.0007; -0.0177; 0.0087; -0.0011; 0.0093	—
SECONDARY Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	1.00; -0.45; 2.10; -0.35; 1.00; 2.00	—
SECONDARY Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	0.30; 0.00; 0.20; 0.45; 0.70; 0.70	—
SECONDARY Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN)	0.0749; -0.1123; -0.1248; -0.1248; -0.0499; -0.1372	—
SECONDARY Change From Baseline in Clinical Chemistry Parameter: Creatinine	21.2160; -3.0940; 139.6720; -0.4420; -1.7680; 3.9780	—
SECONDARY Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)	2.0; -2.0; 2.0; -2.5; 2.0; -3.5	—
SECONDARY Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin	0.0000; 1.1115; 0.0000; 1.5390; 0.0000; 3.4200	—
SECONDARY Change From Baseline in Clinical Chemistry Parameter: Protein	6.00; -2.30; 5.00; -1.85; -1.00; -2.65	—
SECONDARY Change From Baseline in Clinical Chemistry Parameter: Ferritin	-32.00; -12.60; 167.00; -17.30; 28.00; -23.30	—
SECONDARY Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation	-6.900; -14.990; -2.300; 6.385; 6.500; -18.245	—
SECONDARY Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate	-0.380; 0.615; -2.020; -0.310; 0.040; -1.095	—
SECONDARY Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio	-0.010; -0.010; -0.040; 0.050; 0.010; 0.030	—
SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	11.5; -8.0; 9.0; 3.5; 6.0; -0.5	—
SECONDARY Change From Baseline in Heart Rate (HR)	-12.5; -9.0; 2.0; -2.0; 15.0; -8.0	—
SECONDARY Change From Baseline in Weight	-1.00; -0.70; -1.80; -0.25; -2.40; 0.40	—
SECONDARY Change From Baseline in Height	-1.50; 0.85; 0.00; 0.95; 0.00; 1.20	—
SECONDARY Absolute Values of Hemoglobin (Hgb)	11.00; 11.35; 10.85; 11.90; 11.80; 11.50	—
SECONDARY Change From Baseline in Hemoglobin (Hgb)	-0.15; 0.55; 0.5; 0.15; 0.30; 0.45	—
SECONDARY Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL)	0; 0; 2; 2; 0; 0	—
SECONDARY Change in Daprodustat Dose From Starting Dose at Each Study Time Point	0; -1; 0; -0.5; -6; -0.5	—
SECONDARY Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments	1; 0; 0; 0; 0; 1	—
SECONDARY Daprodustat Dose at Each Study Time Point	6.0; 2.0; 6.0; 1.0; 6.0; 1.5	—
SECONDARY Maximum Plasma Concentration (Cmax) of Daprodustat	115.047; 19.447	—
SECONDARY Area Under the Curve (AUC) at Steady State of Daprodustat	185.379; 56.634	—
SECONDARY Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough)	0.4995; NA; 6.540; NA; 0.869; NA	—

Summary

This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated with chronic kidney disease (CKD) incorporating 2 independent sub-trials (Non dialysis [ND] and Dialysis [D]). This study will enroll participants with anemia associated with CKD, in 2 distinct sub-populations differing only by their CKD stage and dialysis requirement (ND: CKD stage 3 to 5 not yet receiving dialysis and D: CKD stage 5d undergoing peritoneal dialysis [PD] or hemodialysis [HD]). The maximum duration of the study will be approximately 60 weeks, including Screening period (up to 4 weeks), treatment period (52 weeks), and follow-up period (4 weeks). Outcome measures are identical for the ND and D sub-trials, but will be separately assessed in each sub- trials, overall and within each age subgroups (12 to less than [<] 18 years, 6 to <12 years, 2 to <6 years, and 3 months to <2 years). Except for PK and dose change, which is within each age group only.

Eligibility Criteria

Inclusion Criteria

Participant must be 3 months to less than ( 2× upper limit of normal (ULN), bilirubin >1.5× ULN (unless bilirubin is fractionated and direct bilirubin <35%), and cirrhosis or current unstable liver or biliary disease.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05682326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.