Clinical Trials

Inclusion Criteria:

* Admitted to an ICU requiring CKRT:

1. Must have AKI stage 2 or greater at the time of CKRT initiation.
2. Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment.
* At least 18 years of age but not older than 80 at the time of enrollment.
* One additional life-threatening organ dysfunction present.
* Acceptable vascular access for CKRT to include adequate lumen size and length of catheters.
* Initial (non-binding) commitment to maintaining current level of care for at least 96 hours.
* C-Reactive Protein \>3.5 mg/dl.

Exclusion Criteria:

* Not expected to survive next 24 hours.
* Anticipated transition to comfort measures or hospice in next 4 days.
* Terminal condition whereby the patient is not expected to survive 28 days or any condition in which therapy is regarded as futile by the PI.
* Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation.
* ICU hospitalization \> 14 days during this hospital admission (to include days spent at ICU of an outside hospital) at the time of screening.
* Active COVID-19 infection with a primary admission diagnosis of COVID-19.
* Acute or chronic use of ventricular assist devices.
* ESRD requiring chronic kidney replacement therapy.
* History of CKD (greater than Stage 3).
* AKI stage 0 or stage 1 at the time of CKRT initiation.
* Non-ATN AKI diagnosis. We intend on relying on local nephrology subspecialty expertise to reasonably exclude non-ATN diagnoses based on clinical suspicions combined with prespecified objective criteria. If there is a reasonable suspicion that the subject has non-ATN AKI based on this, they will be excluded from the trial.
* Acute coronary syndromes, acute stroke, or acute major vascular compromise requiring medical or surgical interventions within 48 hours of randomization.
* Active hemorrhage requiring blood transfusions at the time of screening.
* Acute on Chronic Liver Failure.
* Suspicion of hepato-renal syndrome.
* Presence of any solid organ transplant at any time prior to admission.
* Severe burns with a modified Baux score \> 100
* Bone marrow transplant within the last year.
* Chronic immunosuppression.
* Individuals who have a history of primary or secondary immune disorders including, but not limited to, HIV or AIDS.
* Dry weight of \>150kg.
* Platelet count \<15,000/mm3.
* Patient is a prisoner or member of a vulnerable population.
* Patient is pregnant or breast feeding.
* Concurrent enrollment in another interventional clinical trial for an investigational drug or device.
* Requiring plasmapheresis for any reason during the hospitalization.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/31/2024. Questions regarding updates should be directed to the study team contact.