NCT03799627 (FO2RWARD-2) is a Phase 2 clinical trial of Vadadustat in Anemia, sponsored by Akebia Therapeutics.

Who is sponsoring NCT03799627?

NCT03799627 is sponsored by Akebia Therapeutics.

What drugs are being tested in NCT03799627?

Interventions in NCT03799627: Vadadustat, Epoetin Alfa, Vadadustat TIW.

What condition does NCT03799627 study?

NCT03799627 studies Anemia, Dialysis-dependent Chronic Kidney Disease.

Is NCT03799627 still recruiting?

NCT03799627 is currently completed. Last updated 29 September 2022.

Are results published for NCT03799627?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-09-29 · How we verify

NCT03799627: FO2RWARD-2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa

Completed Phase 2 Results posted Last updated 29 September 2022

What this trial tests

Phase 2 trial testing Vadadustat in Anemia in 175 participants. Completed in 15 July 2020.

Timeline

31 January 2019

Primary endpoint
5 June 2020

15 July 2020

Quick facts

Lead sponsor	Akebia Therapeutics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	175
Start date	31 January 2019
Primary completion	5 June 2020
Estimated completion	15 July 2020
Sites	41 locations across United States

Drugs / interventions tested

Vadadustat — full drug profile →
Epoetin Alfa (EPOETIN ALFA) — full drug profile →
Vadadustat TIW — full drug profile →

Conditions studied

Anemia — all drugs for Anemia →
Dialysis-dependent Chronic Kidney Disease — all drugs for Dialysis-dependent Chronic Kidney Disease →

Sponsor

Akebia Therapeutics — full company profile →

Who can join

Adults 18 to 99, any sex, with Anemia or Dialysis-dependent Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP) Primary · Baseline; Week 10 to Week 12

Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1.

Baseline

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	10.223	± 0.5805
Low Dose of Epoetin Alfa: Vadadustat 450 mg	10.059	± 0.6769
Low Dose of Epoetin Alfa: Epoetin Alfa	10.165	± 0.6806
High Dose of Epoetin Alfa: Vadadustat 300 mg	9.778	± 0.6832
High Dose of Epoetin Alfa: Vadadustat 450 mg	10.288	± 0.5445
High Dose of Epoetin Alfa: Vadadustat 600 mg	10.095	± 0.7150
High Dose of Epoetin Alfa: Epoetin Alfa	9.950	± 0.7950
ESA Hyporesponder: Vadadustat 600 mg	9.530	± 0.2864
ESA Hyporesponder: Epoetin Alfa	9.620	± 0.6925

Change from Baseline at PEP

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	-0.371	± 0.8920
Low Dose of Epoetin Alfa: Vadadustat 450 mg	0.072	± 1.1353
Low Dose of Epoetin Alfa: Epoetin Alfa	0.160	± 0.7519
High Dose of Epoetin Alfa: Vadadustat 300 mg	-0.911	± 1.3515
High Dose of Epoetin Alfa: Vadadustat 450 mg	-0.284	± 1.0383
High Dose of Epoetin Alfa: Vadadustat 600 mg	-0.418	± 1.2752
High Dose of Epoetin Alfa: Epoetin Alfa	0.268	± 1.0087
ESA Hyporesponder: Vadadustat 600 mg	-0.671	± 0.7643
ESA Hyporesponder: Epoetin Alfa	-0.290	± 1.7730

Number of Participants With Treatment-emergent Adverse Events (TEAEs) Primary · Up to Week 24

An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	18
Low Dose of Epoetin Alfa: Vadadustat 450 mg	27
Low Dose of Epoetin Alfa: Epoetin Alfa	13
High Dose of Epoetin Alfa: Vadadustat 300 mg	12
High Dose of Epoetin Alfa: Vadadustat 450 mg	14
High Dose of Epoetin Alfa: Vadadustat 600 mg	13
High Dose of Epoetin Alfa: Epoetin Alfa	9
ESA Hyporesponder: Vadadustat 600 mg	5
ESA Hyporesponder: Epoetin Alfa	3

Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values Primary · Up to Week 24

Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes.

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	0
Low Dose of Epoetin Alfa: Vadadustat 450 mg	0
Low Dose of Epoetin Alfa: Epoetin Alfa	0
High Dose of Epoetin Alfa: Vadadustat 300 mg	0
High Dose of Epoetin Alfa: Vadadustat 450 mg	0
High Dose of Epoetin Alfa: Vadadustat 600 mg	0
High Dose of Epoetin Alfa: Epoetin Alfa	0
ESA Hyporesponder: Vadadustat 600 mg	0
ESA Hyporesponder: Epoetin Alfa	0

Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values Primary · Up to Week 24

Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes.

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	0
Low Dose of Epoetin Alfa: Vadadustat 450 mg	0
Low Dose of Epoetin Alfa: Epoetin Alfa	0
High Dose of Epoetin Alfa: Vadadustat 300 mg	0
High Dose of Epoetin Alfa: Vadadustat 450 mg	0
High Dose of Epoetin Alfa: Vadadustat 600 mg	0
High Dose of Epoetin Alfa: Epoetin Alfa	0
ESA Hyporesponder: Vadadustat 600 mg	0
ESA Hyporesponder: Epoetin Alfa	0

Number of Participants Classified as Hb Outliers Primary · Weeks 13 - 20

The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or \<8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period.

Hb >12.0 g/dL

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	2
Low Dose of Epoetin Alfa: Vadadustat 450 mg	2
Low Dose of Epoetin Alfa: Epoetin Alfa	3
High Dose of Epoetin Alfa: Vadadustat 300 mg	0
High Dose of Epoetin Alfa: Vadadustat 450 mg	1
High Dose of Epoetin Alfa: Vadadustat 600 mg	0
High Dose of Epoetin Alfa: Epoetin Alfa	1
ESA Hyporesponder: Vadadustat 600 mg	0
ESA Hyporesponder: Epoetin Alfa	0

Hb >13.0 g/dL

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	1
Low Dose of Epoetin Alfa: Vadadustat 450 mg	0
Low Dose of Epoetin Alfa: Epoetin Alfa	1
High Dose of Epoetin Alfa: Vadadustat 300 mg	0
High Dose of Epoetin Alfa: Vadadustat 450 mg	0
High Dose of Epoetin Alfa: Vadadustat 600 mg	0
High Dose of Epoetin Alfa: Epoetin Alfa	0
ESA Hyporesponder: Vadadustat 600 mg	0
ESA Hyporesponder: Epoetin Alfa	0

Hb >14.0 g/dL

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	1
Low Dose of Epoetin Alfa: Vadadustat 450 mg	0
Low Dose of Epoetin Alfa: Epoetin Alfa	1
High Dose of Epoetin Alfa: Vadadustat 300 mg	0
High Dose of Epoetin Alfa: Vadadustat 450 mg	0
High Dose of Epoetin Alfa: Vadadustat 600 mg	0
High Dose of Epoetin Alfa: Epoetin Alfa	0
ESA Hyporesponder: Vadadustat 600 mg	0
ESA Hyporesponder: Epoetin Alfa	0

Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	2
Low Dose of Epoetin Alfa: Vadadustat 450 mg	2
Low Dose of Epoetin Alfa: Epoetin Alfa	0
High Dose of Epoetin Alfa: Vadadustat 300 mg	1
High Dose of Epoetin Alfa: Vadadustat 450 mg	1
High Dose of Epoetin Alfa: Vadadustat 600 mg	3
High Dose of Epoetin Alfa: Epoetin Alfa	1
ESA Hyporesponder: Vadadustat 600 mg	1
ESA Hyporesponder: Epoetin Alfa	1

Hb increase >1.0 g/dL within any 2-week interval

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	4
Low Dose of Epoetin Alfa: Vadadustat 450 mg	8
Low Dose of Epoetin Alfa: Epoetin Alfa	4
High Dose of Epoetin Alfa: Vadadustat 300 mg	4
High Dose of Epoetin Alfa: Vadadustat 450 mg	2
High Dose of Epoetin Alfa: Vadadustat 600 mg	3
High Dose of Epoetin Alfa: Epoetin Alfa	6
ESA Hyporesponder: Vadadustat 600 mg	0
ESA Hyporesponder: Epoetin Alfa	2

Number of Participants With Hb Values Within the Target Range at the PEP Secondary · Week 10 to Week 12

The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12.

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	12
Low Dose of Epoetin Alfa: Vadadustat 450 mg	13
Low Dose of Epoetin Alfa: Epoetin Alfa	15
High Dose of Epoetin Alfa: Vadadustat 300 mg	1
High Dose of Epoetin Alfa: Vadadustat 450 mg	4
High Dose of Epoetin Alfa: Vadadustat 600 mg	4
High Dose of Epoetin Alfa: Epoetin Alfa	6
ESA Hyporesponder: Vadadustat 600 mg	0
ESA Hyporesponder: Epoetin Alfa	0

Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12 Secondary · Week 10 to Week 12; Week 18 to Week 20

Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.

Group	Value	95% CI
Vadadustat 300 mg (Starting Dose in TIW Dosing Regimen)	-0.050	± NA
Vadadustat 450 mg (Starting Dose in TIW Dosing Regimen)	-1.021	± 1.0961
Vadadustat 600 mg (Starting Dose in TIW Dosing Regimen)	-0.360	± 0.4894
Vadadustat 750 mg (Starting Dose in TIW Dosing Regimen)	-0.103	± 1.9225
Vadadustat Total (TIW Dosing Regimen)	-0.422	± 1.1708

Mean Change in Hb Between Baseline and the SEP Secondary · Baseline; Week 18 to Week 20

Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20.

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	-0.197	± 1.1597
Low Dose of Epoetin Alfa: Vadadustat 450 mg	-0.186	± 0.8703
Low Dose of Epoetin Alfa: Epoetin Alfa	0.070	± 0.9545
High Dose of Epoetin Alfa: Vadadustat 300 mg	0.114	± 1.0242
High Dose of Epoetin Alfa: Vadadustat 450 mg	-0.421	± 0.8370
High Dose of Epoetin Alfa: Vadadustat 600 mg	-0.545	± 0.9771
High Dose of Epoetin Alfa: Epoetin Alfa	0.343	± 0.8897
ESA Hyporesponder: Vadadustat 600 mg	-0.283	± 0.7371
ESA Hyporesponder: Epoetin Alfa	-0.400	± 1.0157

Number of Participants With Hb Values Within the Target Range at the SEP Secondary · Week 18 to Week 20

The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20.

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	6
Low Dose of Epoetin Alfa: Vadadustat 450 mg	7
Low Dose of Epoetin Alfa: Epoetin Alfa	9
High Dose of Epoetin Alfa: Vadadustat 300 mg	2
High Dose of Epoetin Alfa: Vadadustat 450 mg	3
High Dose of Epoetin Alfa: Vadadustat 600 mg	2
High Dose of Epoetin Alfa: Epoetin Alfa	6
ESA Hyporesponder: Vadadustat 600 mg	1
ESA Hyporesponder: Epoetin Alfa	1

Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing Secondary · Week 18 to Week 20

The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.

Group	Value	95% CI
Vadadustat 300 mg (Starting Dose in TIW Dosing Regimen)	0
Vadadustat 450 mg (Starting Dose in TIW Dosing Regimen)	2
Vadadustat 600 mg (Starting Dose in TIW Dosing Regimen)	2
Vadadustat 750 mg (Starting Dose in TIW Dosing Regimen)	3
Vadadustat Total (TIW Dosing Regimen)	7

Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP Secondary · Week 10 to Week 12

The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12.

Group	Value	95% CI
Low Dose of Epoetin Alfa: Vadadustat 300 mg	14
Low Dose of Epoetin Alfa: Vadadustat 450 mg	19
Low Dose of Epoetin Alfa: Epoetin Alfa	18
High Dose of Epoetin Alfa: Vadadustat 300 mg	1
High Dose of Epoetin Alfa: Vadadustat 450 mg	6
High Dose of Epoetin Alfa: Vadadustat 600 mg	6
High Dose of Epoetin Alfa: Epoetin Alfa	8
ESA Hyporesponder: Vadadustat 600 mg	0
ESA Hyporesponder: Epoetin Alfa	1

Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP Secondary · Week 18 to Week 20

The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20.

Group	Value	95% CI
Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 300 mg	10
Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 450 mg	11
Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Epoetin Alfa	14
High Dose of Epoetin Alfa: Vadadustat 300 mg	3
High Dose of Epoetin Alfa: Vadadustat 450 mg	5
High Dose of Epoetin Alfa: Vadadustat 600 mg	2
High Dose of Epoetin Alfa: Epoetin Alfa	8
ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Vadadustat 600 mg	1
ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Epoetin Alfa	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Low Dose of Epoetin Alfa: Vadadustat 300 mg

Serious: 9/34 (26%)

Deaths: 0/34

Low Dose of Epoetin Alfa: Vadadustat 450 mg

Serious: 7/35 (20%)

Deaths: 0/35

Low Dose of Epoetin Alfa: Epoetin Alfa

Serious: 5/23 (22%)

Deaths: 0/23

High Dose of Epoetin Alfa: Vadadustat 300 mg

Serious: 8/18 (44%)

Deaths: 1/18

High Dose of Epoetin Alfa: Vadadustat 450 mg

Serious: 6/21 (29%)

Deaths: 1/21

High Dose of Epoetin Alfa: Vadadustat 600 mg

Serious: 10/21 (48%)

Deaths: 1/21

High Dose of Epoetin Alfa: Epoetin Alfa

Serious: 5/13 (38%)

Deaths: 1/13

ESA Hyporesponder: Vadadustat 600 mg

Serious: 4/5 (80%)

Deaths: 0/5

ESA Hyporesponder: Epoetin Alfa

Serious: 3/5 (60%)

Deaths: 0/5

Serious adverse events (71 terms)

Reaction	System	Low Dose of Epoetin Alfa: …	Low Dose of Epoetin Alfa: …	Low Dose of Epoetin Alfa: …	High Dose of Epoetin Alfa:…	High Dose of Epoetin Alfa:…	High Dose of Epoetin Alfa:…	High Dose of Epoetin Alfa:…	ESA Hyporesponder: Vadadus…	ESA Hyporesponder: Epoetin…
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—
Fluid overload	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Nephrogenic anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Acute coronary syndrome	Cardiac disorders	—	—	—	—	—	—	—	—	—
Acute left ventricular failure	Cardiac disorders	—	—	—	—	—	—	—	—	—
Atrial flutter	Cardiac disorders	—	—	—	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Incarcerated inguinal hernia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Incarcerated umbilical hernia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Catheter site thrombosis	General disorders	—	—	—	—	—	—	—	—	—
Death	General disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—

Other adverse events (84 terms — click to expand)

Reaction	System	Low Dose of Epoetin Alfa: …	Low Dose of Epoetin Alfa: …	Low Dose of Epoetin Alfa: …	High Dose of Epoetin Alfa:…	High Dose of Epoetin Alfa:…	High Dose of Epoetin Alfa:…	High Dose of Epoetin Alfa:…	ESA Hyporesponder: Vadadus…	ESA Hyporesponder: Epoetin…
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Nephrogenic anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Arteriosclerosis coronary artery	Cardiac disorders	—	—	—	—	—	—	—	—	—
Bundle branch block right	Cardiac disorders	—	—	—	—	—	—	—	—	—
Diastolic dysfunction	Cardiac disorders	—	—	—	—	—	—	—	—	—
Left atrial enlargement	Cardiac disorders	—	—	—	—	—	—	—	—	—
Mitral valve incompetence	Cardiac disorders	—	—	—	—	—	—	—	—	—
Right atrial enlargement	Cardiac disorders	—	—	—	—	—	—	—	—	—
Sinus tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—
Supraventricular tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—
Systolic dysfunction	Cardiac disorders	—	—	—	—	—	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—
Cataract	Eye disorders	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Haematemesis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Ulcer haemorrhage	General disorders	—	—	—	—	—	—	—	—	—
Acarodermatitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Acute myocardial infarction, Sepsis, Fluid overload, Anaemia, Nephrogenic anaemia, Thrombocytopenia, Acute coronary syndrome, Acute left ventricular failure.

Data from ClinicalTrials.gov NCT03799627 adverse events section.

Sponsor's own description

This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Hypoxia-inducible factor-prolyl hydroxylase inhibitors in the treatment of anemia of chronic kidney disease.
Haase VH. · · 2021 · cited 115× · PMID 33777492 · DOI 10.1016/j.kisu.2020.12.002

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NCT04707768 — Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera · Phase 3 · completed
NCT04299633 — Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Va · Phase 1 · completed
NCT04313153 — Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Mainten · Phase 3 · completed

Other recruiting trials for Anemia

Currently open trials in the same condition.

NCT07422480 — A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myel · Phase 3 · recruiting
NCT06968936 — Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy · NA · recruiting
NCT07328191 — Quality of Life-Guided Transfusion in Refractory MDS or AML · NA · recruiting
NCT07315295 — Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya · NA · recruiting
NCT07400796 — Assessing Health System Readiness for Scaling Antenatal MMS in Cambodia · recruiting

Other Akebia Therapeutics trials

Trials by the same sponsor.

NCT04707768 — Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera · Phase 3 · completed
NCT04299633 — Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Va · Phase 1 · completed
NCT04313153 — Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Mainten · Phase 3 · completed
NCT03992066 — Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia · Phase 1 · completed
NCT03789032 — Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03799627 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Akebia Therapeutics
Last refreshed: 29 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03799627.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing