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HIF-PH Inhibitor

Daprodustat for Pediatric Anemia (ASCEND-P Trial)

Phase 3

Recruiting

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

ASCEND-P Trial 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.Check my eligibility

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.See study design

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.

ASCEND-P Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) and up to week 56

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Diarrhoea

Headache

Vomiting

Fluid overload

Nausea

Upper respiratory tract infection

Nasopharyngitis

Hypotension

Muscle spasms

Arteriovenous fistula site complication

Device malfunction

Catheter site infection

Pneumonia

Post procedural infection

Acute coronary syndrome

Sinus bradycardia

Localised infection

Asthma

Respiratory tract infection

Procedural haemorrhage

Infected skin ulcer

Unintentional medical device removal

Volvulus

Staphylococcal bacteraemia

Supraventricular tachycardia

Bloody peritoneal effluent

Gastrooesophageal reflux disease

Cardiac failure

Atrial fibrillation

Haematuria

Subileus

Peritonitis

Septic shock

Clostridium difficile infection

Gastroenteritis

Staphylococcal sepsis

Cardiogenic shock

Staphylococcal infection

Intestinal obstruction

Device related bacteraemia

Angina pectoris

Escherichia infection

Leptospirosis

Streptococcal infection

Pyrexia

Chronic obstructive pulmonary disease

Sudden death

Prostate cancer metastatic

Uraemic encephalopathy

Clostridium difficile colitis

Subcutaneous abscess

Myocardial infarction

Cardiac failure congestive

Aortic valve incompetence

Cardiac failure chronic

Arteriovenous fistula thrombosis

Fall

Subdural haematoma

Acute respiratory failure

Respiratory failure

Pulmonary hypertension

Diabetic gastropathy

Hypertensive encephalopathy

Device dislocation

Retinopathy hypertensive

Urosepsis

Hypertensive heart disease

Humerus fracture

Open globe injury

Catheter site haemorrhage

Urinary tract infection

Bronchiolitis

COVID-19

Clostridial sepsis

Hyperkalaemia

Cardiac failure acute

Anaemia postoperative

Syncope

Hypertensive urgency

Lymphocele

Peripheral vascular disorder

Azotaemia

Chronic kidney disease

Metrorrhagia

Bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Daprodustat

Darbepoetin Alfa

ASCEND-P 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 3

~7530

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,755 Previous Clinical Trials

8,070,715 Total Patients Enrolled

33 Trials studying Anemia

10,734 Patients Enrolled for Anemia

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,820 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 55 or over eligible to enter this research trial?

"For this study, individuals must be under 17 years of age and above the minimum eligible age of 3 months."

Answered by AI

In how many healthcare facilities is this experiment being conducted?

"At the current time, 66 medical sites are participating in this investigation. These can be accessed from major cities such as Atlanta, Boston and Kansas City along with other locations. It is beneficial to seek out a nearby clinic for enrolment so you won't need to travel far."

Answered by AI

Does this experiment in medicine currently accept new participants?

"Based on the information published by clinicaltrials.gov, this trial is not presently accepting participants. It was initially posted on August 4th 2023 and last updated two days later. Nevertheless, there are 229 other trials actively recruiting at this time."

Answered by AI

What potential adverse effects might arise from utilizing Daprodustat?

"A score of 3 was assigned to Daprodustat due to the presence of Phase 3 trial data, which attests to safety and efficacy."

Answered by AI

What are the foremost aims of this clinical experiment?

"This clinical trial, to be carried out over a maximum of 56 weeks, seeks to assess the number of adverse events (AEs) and serious adverse events (SAEs). Secondary objectives include calculating mean daprodustat dose values, counting how many participants are assigned each level of dosage at each visit point, as well as measuring changes in height from baseline."

Answered by AI

To whom is this scientific investigation accessible?

"This clinical experiment is aiming to recruit 120 minors between 3 months and 17 years old with anemia. Furthermore, all participants need to fit the following requirements: be younger than 18 y/o; have CKD stages 3, 4 or 5 (if not receiving dialysis) or being dependent on dialysis (Hgb 7.0-11.0 g/dL if no ESA prescribed / 9.5-12.0 g/dl when taking ESAs); provide written consent or assent as necessary)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05682326.

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