New hope for hospital patients: drug may shield kidneys from harmful meds
NCT ID NCT06886464
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether cilastatin, a drug already used for other purposes, can prevent acute kidney injury in hospitalized patients who must take medications known to harm the kidneys. About 700 adults receiving certain antibiotics, chemotherapy, or contrast dyes will receive either cilastatin or a placebo every six hours. Researchers will monitor kidney function daily and follow up at 90 days to see if the drug reduces kidney damage.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 698 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years * Active treatment with an eligible nephrotoxic medication- IV vancomycin, IV aminoglycoside (gentamicin or tobramycin), IV calcineurin inhibitor (cyclosporine or tacrolimus), or IV or intraperitoneal platin-based chemotherapy or ifosfamide; or intraarterial radiographic contrast with two or more high-risk nephrotoxic medication exposures according to the NINJA algorithm. * Able to provide informed consent or have an authorized representative available and willing to give written informed consent after being properly informed of the nature and risks of the Study. Exclusion Criteria: * Stage 3 AKI based on Kidney Disease Improving Global Outcomes (KDIGO) SCr or urine output criteria, or receipt of short-term dialysis. * Category G5 CKD (defined as a CKD-EPI eGFR or \<15 mL/min/1.73 m2) or being treated with maintenance dialysis or a kidney transplant. * Pregnancy or lactation * Known hypersensitivity to imipenem-cilastatin. * Active or recent treatment (within 48 hours) with imipenem-cilastatin * Active or recent treatment (within 48 hours) with probenecid (medication used for gout prevention that inhibits cilastatin excretion and decreases plasma clearance) * Treatment with another investigational medicinal product or participation in another interventional Study within 30 days * Inability to comply with the requirements of the Study protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Alberta
RECRUITINGEdmonton, Alberta, T6G 2R3, Canada
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University of Calgary
RECRUITINGCalgary, Alberta, T2N 1N4, Canada
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Other studies related to the condition(s) this trial covers.
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- ICU kidney injury: does the pattern predict lasting damage?
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- Can watching kidney oxygen during liver surgery keep kidneys safe?