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Prolyl Hydroxylase Inhibitor

Daprodustat for Anemia

Phase 2
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), day 14 and day 28 in treatment periods 1 and 2 (each period is of 28 days)
Awards & highlights

Study Summary

This trial is testing whether daprodustat, which increases levels of hypoxia-inducible factor (HIF), can increase absorption of oral iron and incorporation into hemoglobin (Hgb) compared to treatment with erythropoietin (EPO).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), day 14 and day 28 in treatment periods 1 and 2 (each period is of 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), day 14 and day 28 in treatment periods 1 and 2 (each period is of 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO
Secondary outcome measures
Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO
Periods 1 and 2: Change From Baseline in Erythrocyte Mean Corpuscular Volume Following Treatment With Daprodustat and rhEPO
Periods 1 and 2: Change From Baseline in Erythrocytes Following Treatment With Daprodustat and rhEPO
+10 more
Other outcome measures
Number of participants discontinued the study medication due to AE
Number of participants with abnormal oral temperature
Number of participants with abnormal pulse rate
+6 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%
Upper respiratory tract infection
4%
Nasopharyngitis
4%
Hypotension
4%
Muscle spasms
3%
Device malfunction
3%
Arteriovenous fistula site complication
3%
Catheter site infection
3%
Pneumonia
2%
Post procedural infection
1%
Staphylococcal bacteraemia
1%
Sinus bradycardia
1%
Acute coronary syndrome
1%
Cardiac failure
1%
Peritonitis
1%
Respiratory tract infection
1%
Atrial fibrillation
1%
Volvulus
1%
Septic shock
1%
Localised infection
1%
Supraventricular tachycardia
1%
Clostridium difficile infection
1%
Gastroenteritis
1%
Staphylococcal sepsis
1%
Cardiogenic shock
1%
Staphylococcal infection
1%
Intestinal obstruction
1%
Device related bacteraemia
1%
Procedural haemorrhage
1%
Subileus
1%
Angina pectoris
1%
Asthma
1%
Escherichia infection
1%
Leptospirosis
1%
Streptococcal infection
1%
Infected skin ulcer
1%
Bloody peritoneal effluent
1%
Haematuria
1%
Unintentional medical device removal
1%
Pyrexia
1%
Chronic obstructive pulmonary disease
1%
Gastrooesophageal reflux disease
1%
Sudden death
1%
Prostate cancer metastatic
1%
Uraemic encephalopathy
1%
Clostridium difficile colitis
1%
Subcutaneous abscess
1%
Myocardial infarction
1%
Cardiac failure congestive
1%
Aortic valve incompetence
1%
Cardiac failure chronic
1%
Arteriovenous fistula thrombosis
1%
Fall
1%
Subdural haematoma
1%
Acute respiratory failure
1%
Respiratory failure
1%
Pulmonary hypertension
1%
Diabetic gastropathy
1%
Hypertensive encephalopathy
1%
Device dislocation
1%
Retinopathy hypertensive
1%
Urosepsis
1%
Hypertensive heart disease
1%
Humerus fracture
1%
Open globe injury
1%
Catheter site haemorrhage
1%
Urinary tract infection
1%
Bronchiolitis
1%
COVID-19
1%
Clostridial sepsis
1%
Hyperkalaemia
1%
Cardiac failure acute
1%
Anaemia postoperative
1%
Syncope
1%
Hypertensive urgency
1%
Lymphocele
1%
Peripheral vascular disorder
1%
Azotaemia
1%
Chronic kidney disease
1%
Metrorrhagia
1%
Bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daprodustat
Darbepoetin Alfa

Trial Design

4Treatment groups
Experimental Treatment
Group I: rhEPO+58Fe followed by Daprodustat+57FeExperimental Treatment4 Interventions
Participants will be randomly assigned to remain on their current therapy (either epoetin alfa or darbepoetin alfa) in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants will be administered ferrous sulfate containing a stable isotope of iron (58Fe) orally in a randomized fashion following 2 weeks of administration of randomized study treatment. At Day 29 participants will be crossed over to receive Daprodustat in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants will again be administered ferrous sulfate containing the stable iron isotope (57Fe) orally. Participants will be advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
Group II: rhEPO+57Fe followed by Daprodustat+58FeExperimental Treatment4 Interventions
Participants will be randomly assigned to remain on their current therapy (either epoetin alfa or darbepoetin alfa) in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants will be administered ferrous sulfate containing a stable isotope of iron (57Fe) orally in a randomized fashion following 2 weeks of administration of randomized study treatment. At Day 29 participants will be crossed over to receive Daprodustat in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants will again be administered ferrous sulfate containing the stable iron isotope (58Fe) orally. Participants will be advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: Histamine [H2] receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
Group III: Daprodustat+58Fe followed by rhEPO+57FeExperimental Treatment4 Interventions
Participants will be randomly assigned to receive Daprodustat in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants will be administered ferrous sulfate containing a stable isotope of iron (58Fe) orally in a randomized fashion following 2 weeks of administration of randomized study treatment. At Day 29 participants will be crossed over to receive rhEPO (either epoetin alfa or darbepoetin alfa) in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants will again be administered ferrous sulfate containing the stable iron isotope (57Fe) orally. Participants will be advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
Group IV: Daprodustat+57Fe followed by rhEPO+58FeExperimental Treatment4 Interventions
Participants will be randomly assigned to receive Daprodustat in Treatment Period 1. For assessment of incorporation of iron into erythrocytes, participants will be administered ferrous sulfate containing a stable isotope of iron (57Fe) orally in a randomized fashion following 2 weeks of administration of randomized study treatment. At Day 29 participants will be crossed over to receive rhEPO (either epoetin alfa or darbepoetin alfa) in Treatment Period 2. At 2 weeks following initiation of dosing in Treatment Period 2, participants will again be administered ferrous sulfate containing the stable iron isotope (58Fe) orally. Participants will be advised to maintain use of oral iron supplementation (except ferric citrate) and acid-reducing agents (example: H2 receptor antagonists, proton pump inhibitors, antacids) at a consistent dosage and frequency.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daprodustat
2020
Completed Phase 3
~7530
Ferrous sulfate containing the stable iron isotope (57Fe)
2019
Completed Phase 2
~20
Ferrous sulfate containing the stable iron isotope (58Fe)
2019
Completed Phase 2
~20
rhEPO
2013
Completed Phase 3
~3610

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,749 Previous Clinical Trials
8,067,413 Total Patients Enrolled
33 Trials studying Anemia
10,839 Patients Enrolled for Anemia
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,915 Total Patients Enrolled
32 Trials studying Anemia
10,678 Patients Enrolled for Anemia

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)
2019. "Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03457701.
~3 spots leftby Apr 2025
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