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HIF-PH Inhibitor

Daprodustat for Pediatric Anemia (ASCEND-P Trial)

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and up to week 56
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will assess the safety, PK and response to daprodustat in children/teens with anemia associated with CKD, and will also compare results between those needing dialysis and those that don't.

Who is the study for?
This trial is for children and adolescents aged 3 months to under 18 years with anemia due to chronic kidney disease (CKD) stages 3-5, not on dialysis, or those on dialysis. Participants must have specific hemoglobin levels depending on their treatment history with erythropoiesis stimulating agents.
What is being tested?
The study tests Daprodustat's effects over a year in managing anemia in young patients with CKD, both undergoing and not undergoing dialysis. It will measure how the body processes the drug, its safety, and its impact on hemoglobin levels across different age groups.
What are the potential side effects?
While specific side effects of Daprodustat in this pediatric population are not detailed here, common ones may include risks related to blood pressure changes, gastrointestinal symptoms like nausea or vomiting, headaches, or potential risks associated with long-term use such as clotting issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and up to week 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and up to week 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with AEs leading to study intervention discontinuation
Number of participants with adverse event of special interests (AESIs)
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Secondary study objectives
Area under the curve (AUC) at steady state of daprodustat and its metabolites
Maximum plasma concentration (Cmax) of daprodustat and its metabolites
Mean Hgb value
+11 more

Side effects data

From 2020 Phase 3 trial • 312 Patients • NCT03029208
17%
Hypertension
13%
Dialysis hypotension
9%
Diarrhoea
8%
Headache
7%
Vomiting
6%
Fluid overload
5%
Nausea
4%
Hypotension
4%
Nasopharyngitis
4%
Upper respiratory tract infection
4%
Muscle spasms
3%
Pneumonia
3%
Device malfunction
3%
Catheter site infection
3%
Arteriovenous fistula site complication
2%
Post procedural infection
1%
Hypertensive encephalopathy
1%
Subileus
1%
Volvulus
1%
Hypertensive urgency
1%
Lymphocele
1%
Fall
1%
Unintentional medical device removal
1%
Chronic obstructive pulmonary disease
1%
Intestinal obstruction
1%
Peripheral vascular disorder
1%
Peritonitis
1%
Clostridium difficile infection
1%
Gastroenteritis
1%
Staphylococcal infection
1%
Urinary tract infection
1%
Urosepsis
1%
Hyperkalaemia
1%
Infected skin ulcer
1%
Staphylococcal sepsis
1%
Septic shock
1%
Device related bacteraemia
1%
Escherichia infection
1%
Localised infection
1%
Bronchiolitis
1%
Clostridial sepsis
1%
Respiratory tract infection
1%
Clostridium difficile colitis
1%
COVID-19
1%
Leptospirosis
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Cardiac failure acute
1%
Cardiac failure chronic
1%
Staphylococcal bacteraemia
1%
Streptococcal infection
1%
Subcutaneous abscess
1%
Angina pectoris
1%
Atrial fibrillation
1%
Bradycardia
1%
Hypertensive heart disease
1%
Cardiac failure
1%
Myocardial infarction
1%
Aortic valve incompetence
1%
Anaemia postoperative
1%
Cardiogenic shock
1%
Sinus bradycardia
1%
Supraventricular tachycardia
1%
Humerus fracture
1%
Arteriovenous fistula thrombosis
1%
Open globe injury
1%
Procedural haemorrhage
1%
Subdural haematoma
1%
Acute respiratory failure
1%
Respiratory failure
1%
Asthma
1%
Pulmonary hypertension
1%
Bloody peritoneal effluent
1%
Diabetic gastropathy
1%
Gastrooesophageal reflux disease
1%
Syncope
1%
Uraemic encephalopathy
1%
Sudden death
1%
Device dislocation
1%
Azotaemia
1%
Chronic kidney disease
1%
Metrorrhagia
1%
Pyrexia
1%
Catheter site haemorrhage
1%
Haematuria
1%
Prostate cancer metastatic
1%
Retinopathy hypertensive
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daprodustat
Darbepoetin Alfa

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DaprodustatExperimental Treatment1 Intervention
All participants will receive daprodustat for up to 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daprodustat
2020
Completed Phase 4
~7690

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,458 Total Patients Enrolled
33 Trials studying Anemia
10,734 Patients Enrolled for Anemia
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,609 Previous Clinical Trials
6,145,484 Total Patients Enrolled
32 Trials studying Anemia
10,573 Patients Enrolled for Anemia

Media Library

Daprodustat (HIF-PH Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05682326 — Phase 3
Anemia Research Study Groups: Daprodustat
Anemia Clinical Trial 2023: Daprodustat Highlights & Side Effects. Trial Name: NCT05682326 — Phase 3
Daprodustat (HIF-PH Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05682326 — Phase 3
~50 spots leftby Jul 2030
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