Trial · NCT04707573
Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4
NCT04707573, Phase 2, Completed, Akebia Therapeutics; results first posted 2022-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4. Trials, record NCT04707573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04707573
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4
- NCT number
- NCT04707573
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Akebia Therapeutics
- Conditions
- Chronic Kidney Disease
- Interventions
- Vadadustat
- First posted
- 2021-01-13
- Last updated
- 2022-06-28
- Results first posted
- 2022-05-17
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. |
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | 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. |
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | 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. |
| Primary | Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings | 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. |
| Primary | Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval | 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. |
| Primary | Change From Baseline in Heart Rate | Baseline; Day 2 | The heart rate evaluation was performed after the participant had been resting comfortably in a supine position for approximately 10 minutes. |
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings | 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. |
| Primary | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of AKB-6548 | 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. |
| Primary | Median Time to Reach Cmax (Tmax) of AKB-6548 | 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. |
| Primary | Mean Terminal Elimination Rate Constant (λz) | 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Day 8 | Intent-to-treat (ITT) population: all enrolled participants who received a dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Up to Day 8 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Up to Day 8 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings | Up to Day 2 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval | Baseline; Day 2 | ITT Population | Milliseconds | MEAN |
| PRIMARY | Change From Baseline in Heart Rate | Baseline; Day 2 | ITT Population | Beats per minute | MEAN |
| PRIMARY | Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings | Up to Day 8 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Geometric Mean Maximum Observed Plasma Concentration (Cmax) of AKB-6548 | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) | Pharmacokinetic (PK) Evaluable Population: all ITT participants who had adequate and reliable PK data for the evaluation of PK of AKB-6548 plasma concentrations. | Micrograms per millilitre (mcg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Median Time to Reach Cmax (Tmax) of AKB-6548 | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) | PK Evaluable Population | Hours | MEDIAN |
| PRIMARY | Mean Terminal Elimination Rate Constant (λz) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) | PK Evaluable Population | 1/Hour | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Cohort 1: CKD Stage 3 Vadadustat | 6 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Cohort 2: CKD Stage 4 Vadadustat | 2 | Participants | ||
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Cohort 1: CKD Stage 3 Vadadustat | Urinalysis | 0 | Participants | |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Cohort 2: CKD Stage 4 Vadadustat | Urinalysis | 0 | Participants | |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Cohort 1: CKD Stage 3 Vadadustat | Hematology | 0 | Participants | |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Cohort 2: CKD Stage 4 Vadadustat | Hematology | 0 | Participants | |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Cohort 1: CKD Stage 3 Vadadustat | Serum chemistry | 1 | Participants | |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Cohort 2: CKD Stage 4 Vadadustat | Serum chemistry | 0 | Participants | |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Cohort 1: CKD Stage 3 Vadadustat | Coagulation | 0 | Participants | |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Cohort 2: CKD Stage 4 Vadadustat | Coagulation | 0 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: CKD Stage 3 Vadadustat | 10 | |
| Overall Study | STARTED | Cohort 2: CKD Stage 4 Vadadustat | 12 | |
| Overall Study | COMPLETED | Cohort 1: CKD Stage 3 Vadadustat | 10 | |
| Overall Study | COMPLETED | Cohort 2: CKD Stage 4 Vadadustat | 12 | |
| Overall Study | NOT COMPLETED | Cohort 1: CKD Stage 3 Vadadustat | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2: CKD Stage 4 Vadadustat | 0 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tachycardia | Cardiac disorders | Cohort 1: CKD Stage 3 Vadadustat | 1 | 10 | |
| other | Tachycardia | Cardiac disorders | Cohort 2: CKD Stage 4 Vadadustat | 0 | 12 | |
| other | Nausea | Gastrointestinal disorders | Cohort 1: CKD Stage 3 Vadadustat | 2 | 10 | |
| other | Nausea | Gastrointestinal disorders | Cohort 2: CKD Stage 4 Vadadustat | 0 | 12 | |
| other | Vomiting | Gastrointestinal disorders | Cohort 1: CKD Stage 3 Vadadustat | 1 | 10 | |
| other | Vomiting | Gastrointestinal disorders | Cohort 2: CKD Stage 4 Vadadustat | 0 | 12 | |
| other | Catheter Site Inflammation | General disorders | Cohort 1: CKD Stage 3 Vadadustat | 0 | 10 | |
| other | Catheter Site Inflammation | General disorders | Cohort 2: CKD Stage 4 Vadadustat | 1 | 12 | |
| other | Pyrexia | General disorders | Cohort 1: CKD Stage 3 Vadadustat | 1 | 10 | |
| other | Pyrexia | General disorders | Cohort 2: CKD Stage 4 Vadadustat | 0 | 12 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: CKD Stage 3 Vadadustat | 0 | 10 |
| Total, all-cause mortality | Cohort 2: CKD Stage 4 Vadadustat | 0 | 12 |
| Total, other adverse events | Cohort 1: CKD Stage 3 Vadadustat | 6 | 10 |
| Total, other adverse events | Cohort 2: CKD Stage 4 Vadadustat | 2 | 12 |
| Total, serious adverse events | Cohort 1: CKD Stage 3 Vadadustat | 0 | 10 |
| Total, serious adverse events | Cohort 2: CKD Stage 4 Vadadustat | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1: CKD Stage 3 Vadadustat vs Cohort 2: CKD Stage 4 Vadadustat: Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings | Trial comparisons |
| Cohort 1: CKD Stage 3 Vadadustat vs Cohort 2: CKD Stage 4 Vadadustat: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Cohort 1: CKD Stage 3 Vadadustat vs Cohort 2: CKD Stage 4 Vadadustat: Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values | Trial comparisons |
| Cohort 1: CKD Stage 3 Vadadustat vs Cohort 2: CKD Stage 4 Vadadustat: Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings | Trial comparisons |
| Cohort 1: CKD Stage 3 Vadadustat vs Cohort 2: CKD Stage 4 Vadadustat: deaths from any cause | Trial comparisons |
| Cohort 1: CKD Stage 3 Vadadustat vs Cohort 2: CKD Stage 4 Vadadustat: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04707573
GET https://conductscience.org/api/trials/v1/NCT04707573/registered?page=2