AnemiaPhase 3TRILOGYNCT03242967
Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
A Phase 3 study testing Vadadustat and Darbepoetin alfa in people with Anemia and Dialysis-Dependent Chronic Kidney Disease, run by Akebia Therapeutics at 1 site in United States.
Trial summary
This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD) 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 Darbepoetin alfa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2017to 12 Feb 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 in-center hemodialysis (3 times per week) for end-stage kidney disease
- Currently maintained on ESA therapy
- Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)
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
1 site in 1 country.
About this study
Official title: Phase 3, Randomized, Open Label, Active Controlled Study Evaluating the Efficacy and Safety of Three Times Per Week (TIW) Oral Dosing of Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILO2GY)
This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
- Conditions
- Anemia, Dialysis-Dependent Chronic Kidney Disease
- Being tested
- Vadadustat, Darbepoetin alfa
- Keywords
- Anemia, hemoglobin, darbepoetin alfa, TIW, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI, AKB-6548, vadadustat, renal, hypoxia-inducible factor, HIF, dialysis-dependent chronic kidney disease, CKD, DD-CKD, kidney, 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
Oral tablet
Darbepoetin alfaDrug
Also called Aranesp
subcutaneous or intravenous
| Study group | Role | What they receive |
|---|---|---|
| Vadadustat | Experimental | Oral tablet Receives: Drug: Vadadustat |
| Darbepoetin alfa | Active comparator | subcutaneous or intravenous Receives: Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Hb between baseline and the primary evaluation period
Mean change in hemoglobin will be evaluated
Measured: Baseline visit, Week 36
Secondary outcomes (3)
Mean change in Hb between baseline and the secondary evaluation period
Mean change in hemoglobin will be evaluated
Measured: Baseline visit, Week 52
Proportion of subjects with mean Hb within the target range during the primary evaluation period
Hemoglobin values within the target range will be evaluated
Measured: Baseline visit, Week 36
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study startAug 2017 (estimated)
- Primary completion12 Feb 2018
- Study completion12 Feb 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akebia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akebia Therapeutics, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242967
- Sponsor's protocol ID
- AKB-6548-CI-0023
- Acronym
- TRILOGY
- Status last verified
- Nov 2018
- First submitted
- 4 Aug 2017
- Last updated
- 5 Nov 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Open Label, Active Controlled Study Evaluating the Efficacy and Safety of Three Times Per Week (TIW) Oral Dosing of Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILO2GY)
- ClinicalTrials.gov ID
- NCT03242967
- Acronym / sponsor ID
- TRILOGY / AKB-6548-CI-0023
- Conditions
- Anemia, Dialysis-Dependent Chronic Kidney Disease
- Keywords
- Anemia, hemoglobin, darbepoetin alfa, TIW, hypoxia-inducible factor prolyl-hydroxylase inhibitor, HIF-PHI, AKB-6548, vadadustat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Revised study design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2017 (estimated)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
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: VadadustatOral tablet |
| Darbepoetin alfa | Active comparator | Drug: Darbepoetin alfasubcutaneous or intravenous |
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 in-center hemodialysis (3 times per week) for end-stage kidney disease
- Currently maintained on ESA therapy
- Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)
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-6548Oral tablet | Drug | Vadadustat |
| Darbepoetin alfaAlso: Aranespsubcutaneous or intravenous | Drug | Darbepoetin alfa |
Primary outcome
Mean change in Hb between baseline and the primary evaluation period
Time frame: Baseline visit, Week 36
Mean change in hemoglobin will be evaluated
3 secondary outcomes
Mean change in Hb between baseline and the secondary evaluation period
Time frame: Baseline visit, Week 52
Proportion of subjects with mean Hb within the target range during the primary evaluation period
Time frame: Baseline visit, Week 36
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vadadustat and Darbepoetin alfa in people with Anemia and Dialysis-Dependent Chronic Kidney Disease, run by Akebia Therapeutics at 1 site 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: withdrawn, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean change in Hb between baseline and the primary evaluation period (time frame: Baseline visit, Week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2018.