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Prolyl Hydroxylase Inhibitor

Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1), day 14 and day 28 in treatment periods 1 and 2 (each period is of 28 days)

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

Diarrhoea

Headache

Vomiting

Fluid overload

Nausea

Hypotension

Nasopharyngitis

Upper respiratory tract infection

Muscle spasms

Pneumonia

Device malfunction

Catheter site infection

Arteriovenous fistula site complication

Post procedural infection

Hypertensive encephalopathy

Subileus

Volvulus

Hypertensive urgency

Lymphocele

Fall

Unintentional medical device removal

Chronic obstructive pulmonary disease

Intestinal obstruction

Peripheral vascular disorder

Peritonitis

Clostridium difficile infection

Gastroenteritis

Staphylococcal infection

Urinary tract infection

Urosepsis

Hyperkalaemia

Infected skin ulcer

Staphylococcal sepsis

Septic shock

Device related bacteraemia

Escherichia infection

Localised infection

Bronchiolitis

Clostridial sepsis

Respiratory tract infection

Clostridium difficile colitis

COVID-19

Leptospirosis

Cardiac failure congestive

Acute coronary syndrome

Cardiac failure acute

Cardiac failure chronic

Staphylococcal bacteraemia

Streptococcal infection

Subcutaneous abscess

Angina pectoris

Atrial fibrillation

Bradycardia

Hypertensive heart disease

Cardiac failure

Myocardial infarction

Aortic valve incompetence

Anaemia postoperative

Cardiogenic shock

Sinus bradycardia

Supraventricular tachycardia

Humerus fracture

Arteriovenous fistula thrombosis

Open globe injury

Procedural haemorrhage

Subdural haematoma

Acute respiratory failure

Respiratory failure

Asthma

Pulmonary hypertension

Bloody peritoneal effluent

Diabetic gastropathy

Gastrooesophageal reflux disease

Syncope

Uraemic encephalopathy

Sudden death

Device dislocation

Azotaemia

Chronic kidney disease

Metrorrhagia

Pyrexia

Catheter site haemorrhage

Haematuria

Prostate cancer metastatic

Retinopathy hypertensive

100%

80%

60%

40%

20%

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