Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin

Launched by MATTHEW JAMES · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called cilastatin can help prevent acute kidney injury (AKI) in patients who are hospitalized and receiving certain medications that can harm the kidneys. The researchers want to find out if cilastatin is effective by comparing it to a placebo, which looks like the drug but doesn’t contain any active ingredients. If you participate, you will either receive cilastatin or the placebo through an intravenous (IV) line every six hours for up to 24 hours after your last dose of the nephrotoxic medication. You’ll also have daily blood tests to check your kidney function while you’re receiving the treatment, and another blood test along with a phone survey 90 days later.

To be eligible for this trial, you need to be at least 18 years old and currently receiving specific medications that could pose a risk to your kidneys. However, you cannot have severe kidney problems, be pregnant or breastfeeding, or have certain allergies or recent treatments that might interfere with the study. This trial is not yet recruiting participants, but if you meet the criteria, it could be an opportunity to help researchers find a way to protect kidney health in patients receiving potentially harmful medications.

Gender

ALL

Eligibility criteria

• 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.