Trial · NCT04707573
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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 |
| PRIMARY | Median Terminal Elimination Half-life (T½) | 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 | Geometric Mean Area Under the Plasma Concentration-time Curve From 0 to Time T Over a Dosing Interval (AUC[0-T]) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) | PK Evaluable Population | mcg*hr/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) | PK Evaluable Population | mcg*hr/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Apparent Oral Clearance (CL/F) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) | PK Evaluable Population | Litre per Hour (L/hr) | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Apparent Volume of Distribution During the Terminal Phase (Vd/F) | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) | PK Evaluable Population | Liter | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Mean Erythropoietin (EPO) | Baseline; 8, 12, and 24 hours post-dose | ITT Population. Overall number of participants analyzed represents participants with valid EPO measurements at both baseline and the post-dose hour. | milli-international units per milliliter | MEAN |
| OTHER_PRE_SPECIFIED | Exploratory: Change From Baseline in Hepcidin at 24 Hours | Baseline; 24 hours post-dose | |||
| OTHER_PRE_SPECIFIED | Exploratory: Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at 24 Hours | Baseline; 24 hours post-dose | |||
| OTHER_PRE_SPECIFIED | Exploratory: Change From Baseline in Transferrin at 24 Hours | Baseline; 24 hours post-dose | |||
| OTHER_PRE_SPECIFIED | Exploratory: Change From Baseline in Cystatin-C at 24 Hours | Baseline; 24 hours post -dose |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04707573/outcomes