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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
No Placebo-Only Group

Summary

This trial tests daprodustat, a drug that helps the body absorb more iron and make red blood cells, in adults with chronic kidney disease-related anemia who are not on dialysis. The study compares daprodustat to another treatment to see which is better at improving iron absorption. Daprodustat is a promising alternative for the treatment of anemia in patients with chronic kidney disease (CKD).

Eligible Conditions
  • Anemia

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO
Secondary study objectives
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 study objectives
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%
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%
Fall
1%
Unintentional medical device removal
1%
Hypertensive urgency
1%
Volvulus
1%
Chronic obstructive pulmonary disease
1%
Intestinal obstruction
1%
Lymphocele
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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 4
~7690
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
4,802 Previous Clinical Trials
8,377,987 Total Patients Enrolled
33 Trials studying Anemia
10,794 Patients Enrolled for Anemia
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,693 Total Patients Enrolled
32 Trials studying Anemia
10,633 Patients Enrolled for Anemia
~2 spots leftby Nov 2025
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