Trial · NCT04251351
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acute kidney injury (AKI) or death among patients enrolled without AKI (Composite outcome) | during first 7 days of enrolment | Composite outcome of development of AKI (defined as creatinine ≥26.5 µmol/L or ≥1.5x baseline), or death at any timepoint |
| Primary | Acute kidney injury (AKI) progression or death among patients enrolled with AKI (Composite outcome) | during first 7 days of enrolment | Composite outcome of worsening of AKI (defined as creatinine ≥2x baseline, or ≥3x baseline, or initiation of RRT or eGFR \<35 ml/min/ 1.73 m2) or death at any timepoint. |
| Secondary | Number of patients with serious adverse events | AST/ALT/total bilirubin during the first 5 days from enrolment; mortality assessed Day 0 to 7. | Number of patients with serious adverse events (mortality and/or hepatotoxicity, as defined by Hy's Law). |
| Secondary | Proportion of patients who develop Major Adverse Kidney Events (MAKE) composite | 90 days | Major Adverse Kidney Events (MAKE) composite, defined as ≥ 1 efficacy renal endpoints: (i) death, (ii) need for renal replacement therapy, (iii)≥ 50% reduction in eGFR from baseline to 90 days. |
| Secondary | Fever clearance time | 6-hourly temperature assessments during first 7 days from enrolment | Time taken for aural temperature: (i) to fall \< 37.5°C (FCT-A), and (ii) to fall \< 37.5°C and remain there for \>24 h (FCT-B) |
| Secondary | Coma recovery | 6-hourly GCS/BCS assessments during first 7 days from enrolment | Time until Glasgow Coma Score (GCS) return to 15 (or Blantyre Coma Score (BCS) return to 5 in preverbal children) |
| Secondary | Longitudinal change in renal function | During the first 7 days from enrolment | As measured by creatinine concentration (umol/L) |
| Secondary | Longitudinal change in markers of hemolysis | during the first 3 days from enrolment | As measured by cell-free haemoglobin (ug/mL), haemopexin (ug/mL), haptoglobin (ug/mL), haem (uM), F2-isoprostane (pg/mL) and isofurans (pg/mL) concentrations |
| Secondary | Longitudinal change of endothelial activation | during the first 3 days from enrolment | As measured by concentrations of angiopoietin-Tie2 pathway markers (i.e. Ang-1, Ang-2, sTie2, sTie1) |
| Secondary | Longitudinal change of immune activation | during the first 3 days from enrolment | As measured by soluble triggering receptor expressed on myeloid cells concentration (sTREM-1; pg/mL) |
| Secondary | Longitudinal change of AKI biomarker | during the first 3 days from enrolment | As measured by cystatin-C concentration (Cys-C; ug/mL) |
| Secondary | Parasite (parasites/ul) clearance | 12-hourly parasitemia assessments during first 7 days from enrolment | as measured by time until two consecutive negative smears (hours), and by rate using the parasite clearance estimator to determine slope half-life (hours) from 12-hourly parasite counts. |
| Secondary | Exploratory analysis with sex | During first 7 days from enrolment | Primary efficacy analyses will be analysed using a logistic regression model to obtain odds ratios, comparing the odds of a combined endpoint of kidney function deterioration or death between treatment groups. A multivariable model including an interaction term (sex and treatment) will be assessed in the primary analyses to explore potential differences between males and females. |
| Secondary | Pharmacokinetic properties | during the first 24 hours from enrolment | Population pharmacokinetic model (relative bioavailability, mean transit absorption time (hours), apparent oral elimination clearance (L/hours), apparent volume of distribution (L) |
| Secondary | Pharmacokinetic properties | during the first 24 hours from enrolment | Peak plasma concentration (Cmax; mg/L) |
| Secondary | Pharmacokinetic properties | during the first 24 hours from enrolment | Time to peak plasma concentration (Tmax; hours) |
| Secondary | Pharmacokinetic properties | during the first 24 hours from enrolment | Terminal elimination (t1/2; hours) |
| Secondary | Pharmacokinetic properties | during the first 24 hours from enrolment | Area under the plasma drug concentration-time curve (AUC0-24; mg×h×L-1) |
| Secondary | Pharmacodynamic relationships | during first 7 days from enrolment | Pharmacodynamic effects on creatinine concentration (mol/L) |
| Secondary | Pharmacodynamic relationships | during first 7 days from enrolment | Pharmacodynamic effects on liver toxicity, as measured by AST and ALT (U/L) |
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.
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