Status:
RECRUITING
Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin
Lead Sponsor:
Matthew James
Collaborating Sponsors:
Alberta Health services
University of Alberta
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to repurpose cilastatin for preventing acute kidney injury (AKI) in hospitalized patients receiving nephrotoxic medications. The trial will evaluate the efficacy of ...
Detailed Description
BACKGROUND People living with chronic diseases frequently require hospitalization, where they are often exposed to a variety of medications. Common medications include drugs for the treatment of cance...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
698 Patients enrolled
Trial Details
Trial ID
NCT06886464
Start Date
July 16 2025
End Date
December 1 2029
Last Update
November 26 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3