Chronic Kidney DiseasePhase 2NCT04707573
Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4
A Phase 2 study testing Vadadustat in people with Chronic Kidney Disease, run by Akebia Therapeutics at 2 sites in United States.
Trial summary
This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose of Vadadustat. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Vadadustat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jul 2010to 24 Sep 2010
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 79 years of age, inclusive
- Chronic Kidney Disease Stage 3 (Estimated Glomerular Filtration Rate [eGFR] 30 to 59 milliliters [mL]/minute) or Stage 4 participants (eGFR of <30 mL/minute that were not yet on dialysis). eGFR was calculated using the Modification of Diet in Renal Disease (MDRD).
- Hemoglobin (Hb) <13.5 grams per deciliter (g/dL) except for Polycystic Kidney Disease (PKD) participants, in which Hb was to be ≤14 g/dL
- Transferrin saturation (TSAT) >12% and complete blood count (CBC) indicating normocytic red blood cell morphology, unless the medical monitor and investigator agreed that the participant was appropriate for this study
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.8 x upper limit of normal (ULN)
- Alkaline phosphatase ≤2 x ULN
Show all 10Show fewer
- Bilirubin ≤1.5 x ULN
- Female participants were not pregnant or breastfeeding. Women of childbearing potential agreed to use an acceptable method of contraception.
- Non-vasectomized male participants agreed to use an acceptable method of contraception
- Understood the procedures and requirements of the study and provided written informed consent and authorization for protected health information disclosure
Who cannot join
- Any medical or psychological condition that in the opinion of the Investigator would have interfered with the participant's ability to provide informed consent or comply with study instructions
- Any clinically significant or uncontrolled medical condition that in the opinion of the Investigator would have placed the participant at undo risk or would have compromised the interpretability of the findings in this study
- A body mass index (BMI) of greater than 40
- Seropositive for human immunodeficiency virus (HIV) or Hepatitis B surface antigen
- Seropositive for Hepatitis C virus (HCV) antibodies unless ALT, AST, bilirubin tests were within normal limits
- History of chronic liver disease
Show all 28Show fewer
- Uncontrolled hypertension (diastolic blood pressure [BP] > 110 millimeters of mercury [mm Hg] or systolic BP >190 mm Hg at screening)
- New York Heart Association Class III or IV congestive heart failure
- Myocardial infarction, acute coronary syndrome, or stroke within 6 months of dosing
- History of myelodysplastic syndrome
- Participants known to have diabetic gastroparesis that was either symptomatic on therapy or was refractory to therapy
- Any history of malignancy in the previous 5 years except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps
- Evidence of active infection unless the medical monitor and investigator agreed that the participant was appropriate for this study
- History of rheumatoid arthritis or systemic lupus erythematosus (SLE) (History of osteoarthritis or gout did not exclude participants from eligibility in the study.)
- Age-related macular degeneration (AMD), diabetic macular edema or active diabetic proliferative retinopathy that was likely to require treatment during the trial
- History of deep vein thrombosis (DVT) that required active treatment. Superficial thrombosis was not excluded.
- History of ongoing hemolysis or diagnosis of hemolytic syndrome
- Known history of bone marrow fibrosis
- History of hemosiderosis or hemochromatosis
- Androgen therapy within 21 days from the last injection
- Red blood cell transfusion within 12 weeks
- Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 21 days
- Intravenous iron supplementation within the past 21 days
- Currently taking acetaminophen > 2.6 grams/day
- History of prior organ transplantation, or stem cell or bone marrow transplantation
- Alcohol consumption greater than 14 or more drinks per week within the past year (1 drink = 12 ounce [oz] beer, 5 oz wine, or 1.5 oz hard liquor.)
- Use of an investigational medication or participation in an investigational study within 30 days, or 5 half-lives of the investigational product, whichever was longer, preceding Day 1
- Positive urine toxicology screen for a substance of abuse that had not been prescribed for the participant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Knoxville, Tennessee, 37920
Research Site
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 2A Single Dose, Open Label Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Subjects With Chronic Kidney Disease (CKD), Stages 3 and 4
This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose of Vadadustat.
- Conditions
- Chronic Kidney Disease
- Being tested
- Vadadustat
- Keywords
- CKD, CKD, Stage 3, CKD, Stage 4, Vadadustat, pharmacokinetics
- Medical subject headings
- Renal Insufficiency, Chronic
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 capsules
| Study group | Role | What they receive |
|---|---|---|
| CKD, Stage 3 | Experimental | Participants with Stage 3 Chronic Kidney Disease (CKD) (Estimated Glomerular Filtration Rate [eGFR] 30 - 59 milliliters [mL]/minute) received a single 500 milligram (mg) oral dose of Vadadustat after fasting for at least 4 hours. Receives: Drug: Vadadustat |
| CKD, Stage 4 | Experimental | Participants with Stage 4 CKD (eGFR <30 mL/minute and not yet on dialysis) received a single 500 mg oral dose of Vadadustat after fasting for at least 4 hours. Receives: Drug: Vadadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An Adverse Event (AE) was defined as any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study following study medication administration, regardless of causal relationship. This also included any clinically significant worsening or re-occurrence of a pre-existing condition, or AE occurring from an overdose of a study drug whether accidental or intentional or AE occurring from abuse of study drug or that has been associated with the discontinuation of the use of study drug.
Measured: Up to Day 8
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Measured: Up to Day 8
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
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 laboratory results for clinically significant changes. Number of participants with a clinically significant change from baseline in at least one of the assessed vital signs parameters is reported.
Measured: Up to Day 8
Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings
A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance.
Measured: Up to Day 2
Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval
A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected). The baseline was defined as Day 1 pre-dose measurement. If missing, the last measurement prior to dosing was used.
Measured: Baseline; Day 2
Change From Baseline in Heart Rate
The heart rate evaluation was performed after the participant had been resting comfortably in a supine position for approximately 10 minutes.
Measured: Baseline; Day 2
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
A baseline physical examination was performed at screening. Otherwise, abbreviated physical examinations were conducted and were to include heart, lung, and abdomen. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Measured: Up to Day 8
Geometric Mean Maximum Observed Plasma Concentration (Cmax) of AKB-6548
Plasma samples were collected from the participants at the defined time points. Cmax was defined as the maximum observed plasma concentration. Cmax was calculated using the standard non-compartmental method.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Median Time to Reach Cmax (Tmax) of AKB-6548
Plasma samples were collected from the participants at the defined time points. Tmax was defined as the time to reach maximum plasma concentration. Tmax was calculated using the standard non-compartmental method.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Mean Terminal Elimination Rate Constant (λz)
Plasma samples were collected from the participants at the defined time points. λz was calculated using linear regression of the terminal linear portion of the log concentration vs. time curve. The parameter was calculated by linear least-squares regression analysis using three or more concentrations, excluding Cmax.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Median Terminal Elimination Half-life (T½)
Plasma samples were collected from the participants at the defined time points. T½ was defined as apparent terminal elimination half-life. T½ was calculated using the standard non-compartmental method.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Geometric Mean Area Under the Plasma Concentration-time Curve From 0 to Time T Over a Dosing Interval (AUC[0-T])
Plasma samples were collected from the participants at the defined time points. AUC[0-T) was defined as the area under the plasma concentration-time curve, from time=0 to the last measurable concentration (Ct) up to 24 hours, calculated by the linear trapezoidal method. AUC[0-T) was calculated using the standard noncompartmental method.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Geometric Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-∞])
Plasma samples were collected from the participants at the defined time points. AUC[0-∞] was defined as the area under the plasma concentration-time curve from time=0 and extrapolated to infinity. AUC[0-∞] was calculated using the standard non-compartmental method.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Geometric Mean Apparent Oral Clearance (CL/F)
Plasma samples were collected from the participants at the defined time points. CL/F was defined as apparent oral clearance, calculated as Dose/AUC(0-inf). CL/F was calculated using the standard non-compartmental method.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Geometric Mean Apparent Volume of Distribution During the Terminal Phase (Vd/F)
Plasma samples were collected from the participants at the defined time points. Vd/F was defined as the apparent volume of distribution during the terminal phase, calculated as Dose/[λz * AUC(0-inf)]. Vd/F was calculated using the standard non-compartmental method.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Secondary outcomes (1)
Change From Baseline in Mean Erythropoietin (EPO)
The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.
Measured: Baseline; 8, 12, and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start8 Jul 2010
- Primary completion24 Sep 2010
- Study completion24 Sep 2010
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 Chronic Kidney DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akebia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Akebia Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707573
- Sponsor's protocol ID
- AKB-6548-CI-0003
- Status last verified
- Jun 2022
- First submitted
- 2 Nov 2020
- Last updated
- 28 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A Single Dose, Open Label Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Subjects With Chronic Kidney Disease (CKD), Stages 3 and 4
- ClinicalTrials.gov ID
- NCT04707573
- Acronym / sponsor ID
- AKB-6548-CI-0003
- Conditions
- Chronic Kidney Disease
- Keywords
- CKD, CKD, Stage 3, CKD, Stage 4, Vadadustat, pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2010 (actual)
- Primary completion
- 24 Sep 2010 (actual)
- Study completion
- 24 Sep 2010 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose of Vadadustat.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD, Stage 3 | Experimental | Drug: VadadustatParticipants with Stage 3 Chronic Kidney Disease (CKD) (Estimated Glomerular Filtration Rate [eGFR] 30 - 59 milliliters [mL]/minute) received a single 500 milligram (mg) oral dose of Vadadustat after fasting for at least 4 hours. |
| CKD, Stage 4 | Experimental | Drug: VadadustatParticipants with Stage 4 CKD (eGFR <30 mL/minute and not yet on dialysis) received a single 500 mg oral dose of Vadadustat after fasting for at least 4 hours. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 to 79 years of age, inclusive
- Chronic Kidney Disease Stage 3 (Estimated Glomerular Filtration Rate [eGFR] 30 to 59 milliliters [mL]/minute) or Stage 4 participants (eGFR of <30 mL/minute that were not yet on dialysis). eGFR was calculated using the Modification of Diet in Renal Disease (MDRD).
- Hemoglobin (Hb) <13.5 grams per deciliter (g/dL) except for Polycystic Kidney Disease (PKD) participants, in which Hb was to be ≤14 g/dL
- Transferrin saturation (TSAT) >12% and complete blood count (CBC) indicating normocytic red blood cell morphology, unless the medical monitor and investigator agreed that the participant was appropriate for this study
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.8 x upper limit of normal (ULN)
Key exclusion criteria (28 listed)
- Any medical or psychological condition that in the opinion of the Investigator would have interfered with the participant's ability to provide informed consent or comply with study instructions
- Any clinically significant or uncontrolled medical condition that in the opinion of the Investigator would have placed the participant at undo risk or would have compromised the interpretability of the findings in this study
- A body mass index (BMI) of greater than 40
- Seropositive for human immunodeficiency virus (HIV) or Hepatitis B surface antigen
- Seropositive for Hepatitis C virus (HCV) antibodies unless ALT, AST, bilirubin tests were within normal limits
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 capsules | Drug | CKD, Stage 3, CKD, Stage 4 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 8
An Adverse Event (AE) was defined as any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study following study medication administration, regardless of causal relationship. This also included any clinically significant worsening or re-occurrence of a pre-existing condition, or AE occurring from an overdose of a study drug whether accidental or intentional or AE occurring from abuse of study drug or that has been associated with the discontinuation of the use of study drug.
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Time frame: Up to Day 8
Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
Time frame: Up to Day 8
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 laboratory results for clinically significant changes. Number of participants with a clinically significant change from baseline in at least one of the assessed vital signs parameters is reported.
Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings
Time frame: Up to Day 2
A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance.
Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval
Time frame: Baseline; Day 2
A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected). The baseline was defined as Day 1 pre-dose measurement. If missing, the last measurement prior to dosing was used.
Change From Baseline in Heart Rate
Time frame: Baseline; Day 2
The heart rate evaluation was performed after the participant had been resting comfortably in a supine position for approximately 10 minutes.
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings
Time frame: Up to Day 8
A baseline physical examination was performed at screening. Otherwise, abbreviated physical examinations were conducted and were to include heart, lung, and abdomen. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Geometric Mean Maximum Observed Plasma Concentration (Cmax) of AKB-6548
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Plasma samples were collected from the participants at the defined time points. Cmax was defined as the maximum observed plasma concentration. Cmax was calculated using the standard non-compartmental method.
Median Time to Reach Cmax (Tmax) of AKB-6548
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Plasma samples were collected from the participants at the defined time points. Tmax was defined as the time to reach maximum plasma concentration. Tmax was calculated using the standard non-compartmental method.
Mean Terminal Elimination Rate Constant (λz)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Plasma samples were collected from the participants at the defined time points. λz was calculated using linear regression of the terminal linear portion of the log concentration vs. time curve. The parameter was calculated by linear least-squares regression analysis using three or more concentrations, excluding Cmax.
Median Terminal Elimination Half-life (T½)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Plasma samples were collected from the participants at the defined time points. T½ was defined as apparent terminal elimination half-life. T½ was calculated using the standard non-compartmental method.
Geometric Mean Area Under the Plasma Concentration-time Curve From 0 to Time T Over a Dosing Interval (AUC[0-T])
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Plasma samples were collected from the participants at the defined time points. AUC[0-T) was defined as the area under the plasma concentration-time curve, from time=0 to the last measurable concentration (Ct) up to 24 hours, calculated by the linear trapezoidal method. AUC[0-T) was calculated using the standard noncompartmental method.
Geometric Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-∞])
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Plasma samples were collected from the participants at the defined time points. AUC[0-∞] was defined as the area under the plasma concentration-time curve from time=0 and extrapolated to infinity. AUC[0-∞] was calculated using the standard non-compartmental method.
Geometric Mean Apparent Oral Clearance (CL/F)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Plasma samples were collected from the participants at the defined time points. CL/F was defined as apparent oral clearance, calculated as Dose/AUC(0-inf). CL/F was calculated using the standard non-compartmental method.
Geometric Mean Apparent Volume of Distribution During the Terminal Phase (Vd/F)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)
Plasma samples were collected from the participants at the defined time points. Vd/F was defined as the apparent volume of distribution during the terminal phase, calculated as Dose/[λz * AUC(0-inf)]. Vd/F was calculated using the standard non-compartmental method.
1 secondary outcome
Change From Baseline in Mean Erythropoietin (EPO)
Time frame: Baseline; 8, 12, and 24 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Chief Medical Officer study director
Akebia Therapeutics
2 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 in people with Chronic Kidney Disease, run by Akebia Therapeutics at 2 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 10 inclusion and 28 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: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 17 May 2022). 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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to Day 8). The study lists 15 primary outcomes in all. 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 28 Jun 2022.