An observational study in Acute Kidney Injury, sponsored by BioPorto Diagnostics. Enrolling by invitation at 4 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by BioPorto Diagnostics · Observational
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Among 370 studies in Acute Kidney Injury with a site in United States — 72 open to participants now, 88 under way, 9 of them phase 3. Acute Kidney Injury · United States.
Among the 370 studies in Acute Kidney Injury with a site in United States, this one is the 30th largest by planned enrollment of the 131 observational ones that give a count, is one of 29 that started in 2026, is one of 132 observational ones, reaches primary completion later than 51 of the 87 other live ones, and was the 364th registered.
1,691 studies on the registry are indexed under Acute Kidney Injury; 393 are open to participants now.
Browse Acute Kidney Injury studies →72 of the 370 studies in Acute Kidney Injury with a site in United States are open now. Recruiting first, the newest first:
University of Minnesota · Sites in United States
Ages 30–75
Massachusetts General Hospital · Sites in United States
Ages 18+
University of California, San Francisco · Sites in United States
Ages 18+
Bassett Healthcare · Sites in United States
Ages 18+
Dana Fuhrman · Sites in United States
Ages up to 18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 230 Acute Kidney Injury studies recruiting now, 162 (70%) set no upper age limit and 35 (15%) stop at 75 or younger; 22 take children under 18; 25 take healthy volunteers.
This study: 22 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
370 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 26 · Phase 2 69 · Phase 3 29 · Phase 4 23
First in 1999; this study’s year is marked. 29 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 800 is above the median of 160 across 814 observational studies indexed under Acute Kidney Injury.
Median enrollment 67 across the 237 interventional studies, 124 across the 131 observational. Of the 240 that completed or were terminated, 84 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
97 of 370 have an industry lead sponsor. The 10 most frequent:
BioPorto Diagnostics is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
BioPorto Diagnostics has 3 studies filed under Acute Kidney Injury — fewer than ten, so there is no comparison to draw.
33 of the studies in Acute Kidney Injury with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07161843Phase 3Ebima Clifford OkundayeUse of QRX3 for Acute Tubular Necrosis Type of Renal Failure in Hospitalized Patients ( QRX-3 in ARF) | 2026-12-30 |
| NCT05399537Phase 3Vantive Health LLCSafety Evaluation of Prismocitrate 18 in Patients Receiving CRRT | 2027-01 |
| NCT05084196Phase 3Rutgers, The State University of New JerseyMelatonin for Prevention of Kidney Injury | 2027-06-01 |
| NCT07001098Stanford UniversityAmino Acids for Cardiac Surgery Associated AKI | 2026-11 |
| NCT07016074University of MichiganInorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury | 2026-11-30 |
Add all 33 to your calendar (.ics) → With an account.
Among the 370 studies in Acute Kidney Injury with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the performance of the ProNephro AKI™ (NGAL) test for identifying critically ill adults at risk of developing moderate to severe acute kidney injury (KDIGO Stage 2/3) within 48 to 72 hours of ICU admission.
The study will assess how accurately the test predicts acute kidney injury by evaluating its sensitivity, specificity, positive predictive value, and negative predictive value. Participants will provide blood and urine samples for testing.
Patients admitted to the ICU 22 years of age and older
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Males and females ≥ 22 years of age. Subjects must be admitted or admission pending to an Intensive Care Unit and must have a urine sample collected within 24 hours of ICU admission.
Subjects must have at least one of the following, leading to admission to the ICU, or occurring within 24 hours of admission to the ICU (unless otherwise specified):
Vasoactive medication administration Mechanical ventilation Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula Serum Lactate greater than 2.5 mmol/L, within 6 hours prior to enrollment History (any) of solid organ transplantation, renal transplantation included only if more than 3 months prior History (any) of bone marrow transplantation Ability to provide written
Exclusion Criteria:
Special populations including pregnant and lactating women, prisoners, or institutionalized individuals.
Subjects receiving Kidney Replacement Therapy in the first 24 hours of ICU admission.
Subjects diagnosed with active Urinary Tract Infection per institute standard of care at the time of NGAL sampling.
Subjects with a known history of chronic kidney disease stages 4 or 5 as evidenced by a pre-enrollment estimated of less than 30 mL/min/1.73m2.
Subjects with any known urothelial, urological or kidney .
Subjects that have had any of the following urologic procedure or urologic surgery within 30 days prior to ICU admission:
Nephrostomy or nephroureteral stent placement Ureteral stent placement or exchange Ureteroscopy Lithotripsy Transurethral resection of the prostate Transurethral resection of bladder tumor Renal Subjects that have had surgical nephrectomy less than 3 months prior to admission.
Subjects that have been previously enrolled in this study. Subjects enrolled in an interventional pharmaceutical or device clinical trial ICU admission.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ProNephro AKI™ (NGAL) is an immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.
Sensitivity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Percentage of evaluable participants with independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours who have a T0 urinary NGAL concentration of 172 ng/mL or greater, as measured using the ProNephro AKI™ assay.
Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Specificity of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Percentage of evaluable participants without independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours who have a T0 urinary NGAL concentration below 172 ng/mL, as measured using the ProNephro AKI™ assay.
Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Positive Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Percentage of evaluable participants with a T0 urinary NGAL concentration of 172 ng/mL or greater who have independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours, as measured using the ProNephro AKI™ assay.
Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Negative Predictive Value of the ProNephro AKI™ Urinary NGAL Test at the 172 ng/mL Cut-off
Percentage of evaluable participants with a T0 urinary NGAL concentration below 172 ng/mL who do not have independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury at 48 to 72 hours, as measured using the ProNephro AKI™ assay.
Time frame: T0 urine specimen collected within 24 hours of ICU admission; AKI status assessed at 48 to 72 hours after ICU admission
Correlation Between Urinary and Plasma NGAL Concentrations Measured Using the ProNephro AKI™ Assay
Pearson's r correlation coefficient for paired urinary and plasma NGAL concentrations measured in ng/mL at the same protocol-defined collection time points.
Time frame: Across protocol-defined collection time points through 72 hours after ICU admission
Agreement Between Urinary and Plasma NGAL Concentrations Measured Using the ProNephro AKI™ Assay
Agreement between paired urinary and plasma NGAL concentrations measured in ng/mL at the same protocol-defined collection time points will be assessed using Passing-Bablok regression.
Time frame: Across protocol-defined collection time points through 72 hours after ICU admission
Change in Urinary NGAL Concentration Over Time by KDIGO Stage 2/3 Acute Kidney Injury Status
Change in urinary NGAL concentration, measured in ng/mL using the ProNephro AKI™ assay, will be evaluated over the protocol-defined collection time points and summarized separately for participants with and without independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury.
Time frame: From T0 specimen collection through 72 hours after ICU admission
Percentage of Participants Developing KDIGO Stage 2/3 Acute Kidney Injury by Sequential Urinary NGAL Pattern
Percentage of participants who develop independently adjudicated KDIGO Stage 2 or Stage 3 acute kidney injury, summarized according to sequential urinary NGAL patterns at T0 and T1: negative to negative, negative to positive, positive to positive, and positive to negative. Positive or negative NGAL status will be determined using the 172 ng/mL cut-off.
Time frame: From T0 specimen collection through assessment of acute kidney injury status at 72 hours after ICU admission
Plan to share: Undecided — The sponsor has not yet determined whether individual participant data will be made available. The data-sharing plan is under evaluation and may be updated as the study progresses.
Started Jul 2026 (actual). Primary completion is estimated for Nov 2027, 16 months after the start.
Of 365 observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 16 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Jul 2026, on Oct 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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BioPorto Diagnostics