AnemiaPhase 2NCT03140722

Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

A Phase 2 study testing vadadustat and epoetin alfa in people with Anemia and Dialysis-Dependent Chronic Kidney Disease, run by Akebia Therapeutics at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a Phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa for the treatment of anemia in subjects with Dialysis-dependent Chronic Kidney Disease (DD-CKD) who are hyporesponsive to erythropoiesis stimulating agents (ESAs.) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia, Dialysis-Dependent Chronic Kidney Disease
What is being tested?: vadadustat and epoetin alfa
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 18 sitesUnited States
Study dates: 2 May 2017to 21 Mar 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female subjects ≥18 years of age
Receiving chronic maintenance hemodialysis for end-stage kidney disease
Currently receiving epoetin alfa for anemia
Hb between 8.5 and 10.0 g/dL during screening

Who cannot join

Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
Red blood cell transfusion within 4 weeks prior to or during screening
Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Research Site
Bakersfield, California, 93309
Research Site
Detroit, Michigan, 48224
Research Site
El Paso, Texas, 79915
Research Site
Elk Grove, California, 95758
Research Site
Encino, California, 91316
Research Site
Escondido, California, 92025
Research Site
Houston, Texas, 77070
Research Site
Lynwood, California, 90262
Research Site
Miami, Florida, 33183
Research Site
Newport News, Virginia, 23605
Research Site
Norfolk, Virginia, 23502
Research Site
Orlando, Florida, 32804
Research Site
Philadelphia, Pennsylvania, 19106
Research Site
San Diego, California, 92115
Research Site
San Luis Obispo, California, 93401
Research Site
Statesboro, Georgia, 30458
Research Site
The Bronx, New York, 10473
Research Site
Waterbury, Connecticut, 06708

Other trials in United States

About this study

Official title: Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

Conditions: Anemia, Dialysis-Dependent Chronic Kidney Disease
Being tested: vadadustat, epoetin alfa
Keywords: anemia, kidney, dialysis-dependent chronic kidney disease, CKD, DD-CKD, renal, vadadustat, AKB-6548, hypoxia-inducible factor, HIF, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI, hyporesponder, hyporesponsive, epoetin alfa, hemoglobin, erythropoiesis stimulating agent, ESA
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vadadustatDrug
Also called AKB-6548
vadadustat
epoetin alfaDrug
epoetin alfa

Study groups in NCT03140722
Study group	Role	What they receive
vadadustat	Experimental	Vadadustat daily oral dose, adjustable based on Hb level Receives: Drug: vadadustat
epoetin alfa	Active comparator	Epoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study Receives: Drug: epoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period
Measured: Baseline; up to 20 weeks

Secondary outcomes (9)

Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period
Measured: Baseline; up to 20 weeks
Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period
Measured: Baseline; up to 20 weeks
Number of Participants Receiving Epoetin Alfa Rescue
Measured: up to 20 weeks
Number of Participants Receiving Red Blood Cell Transfusion
Measured: up to 20 weeks
Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor
Measured: up to 20 weeks
Mean Weekly Dose of Intravenous Elemental Iron Administered
Measured: up to 20 weeks
Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%)
Measured: up to 20 weeks
Number of Participants Utilizing Resources
Measured: up to 20 weeks
Number of Participants With Treatment-emergent Adverse Events
Treatment-emergent adverse events were collected in all participants enrolled in the study.
Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 201721 Mar 2018

First posted4 May 2017
Study start2 May 2017
Primary completion21 Mar 2018
Study completion21 Mar 2018

Why it stopped: Revised study design.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03140722
Sponsor's protocol ID: AKB-6548-CI-0018
Status last verified: Feb 2021
First submitted: 3 May 2017
Last updated: 21 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Myelodysplastic Syndromes
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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents
ClinicalTrials.gov ID: NCT03140722
Acronym / sponsor ID: AKB-6548-CI-0018
Conditions: Anemia, Dialysis-Dependent Chronic Kidney Disease
Keywords: anemia, kidney, dialysis-dependent chronic kidney disease, CKD, DD-CKD, renal, vadadustat, AKB-6548
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Revised study design.
Enrolment: 2 participants (actual)
Lead sponsor: Akebia TherapeuticsIndustry (pharma, biotech, devices)
Study start: 2 May 2017 (actual)
Primary completion: 21 Mar 2018 (actual)
Study completion: 21 Mar 2018 (actual)
First posted: 4 May 2017 (actual)
Results: Posted 21 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
vadadustat	Experimental	Drug: vadadustatVadadustat daily oral dose, adjustable based on Hb level
epoetin alfa	Active comparator	Drug: epoetin alfaEpoetin alfa, dose adjustable based on Hb level, as clinically indicated throughout the study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male and female subjects ≥18 years of age
Receiving chronic maintenance hemodialysis for end-stage kidney disease
Currently receiving epoetin alfa for anemia
Hb between 8.5 and 10.0 g/dL during screening

Key exclusion criteria (4 listed)

Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
Red blood cell transfusion within 4 weeks prior to or during screening
Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
vadadustatAlso: AKB-6548vadadustat	Drug	vadadustat
epoetin alfaepoetin alfa	Drug	epoetin alfa

Primary outcome

Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period
Time frame: Baseline; up to 20 weeks

9 secondary outcomes

Number of Participants Demonstrating Incremental Increases in Hb From Baseline Over Time During the Treatment Period
Time frame: Baseline; up to 20 weeks
Number of Participants With Hb Values Within the Target Range of 10.0-11.0 Grams Per Deciliter (g/dL) During the Treatment Period
Time frame: Baseline; up to 20 weeks
Number of Participants Receiving Epoetin Alfa Rescue
Time frame: up to 20 weeks
Number of Participants Receiving Red Blood Cell Transfusion
Time frame: up to 20 weeks
Number of Participants With Specified Levels of Various Biomarkers, Including C-reactive Protein, Hepcidin, and Vascular Endothelial Growth Factor
Time frame: up to 20 weeks
Mean Weekly Dose of Intravenous Elemental Iron Administered
Time frame: up to 20 weeks
Number of Participants Maintaining Iron Sufficiency (Defined as Ferritin ≥100 Nanograms Per Milliliter and Transferrin Saturation ≥20%)
Time frame: up to 20 weeks
Number of Participants Utilizing Resources
Time frame: up to 20 weeks
Number of Participants With Treatment-emergent Adverse Events
Time frame: up to 24 weeks

Results and safety

Results posted to the registry on 21 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vadadustat	0	0
Epoetin Alfa	2	2

Primary outcome: Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period

Time frame: Baseline; up to 20 weeks

Population analysed: No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=2). In order to protect the privacy of participants, the results of enrolled participants cannot be reported.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to Week 24. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vadadustat	0 of 0	0 of 0	0
Epoetin Alfa	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): The Study was closed by the Sponsor as it was determined that it was more appropriate to initiate a new study that would explore the broader population utilizing a modified dosing approach (rather than amending the current protocol design).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Anemia

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Akebia Therapeutics study director

Sponsor GmbH

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vadadustat and epoetin alfa in people with Anemia and Dialysis-Dependent Chronic Kidney Disease, run by Akebia Therapeutics at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period (time frame: Baseline; up to 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03140722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.