Actively Recruiting
Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin
Led by Matthew James · Updated on 2025-11-26
698
Participants Needed
2
Research Sites
228 weeks
Total Duration
On this page
Sponsors
M
Matthew James
Lead Sponsor
A
Alberta Health services
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 the re-purposed drug. The main questions it aims to answer are: \- whether cilastatin will prevent nephrotoxic AKI in hospitalized patients. Researchers will compare the drug cilastatin to a placebo (a look-alike substance that contains no drug) to see if drug cilastatin works to prevent AKI in hospitalized patients receiving nephrotoxic medications. Participants will: * Receive drug Cilastatin or a placebo intravenously every 6 hours for up to 24 hours after last exposure to nephrotoxic medication * Have blood test for kidney function every day they are on treatment. * Have a follow-up blood test at 90 days after randomization * Have a telephone survey at 90 days after randomization
CONDITIONS
Official Title
Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Currently receiving an eligible nephrotoxic medication such as IV vancomycin, IV aminoglycoside (gentamicin or tobramycin), IV calcineurin inhibitor (cyclosporine or tacrolimus), IV or intraperitoneal platin-based chemotherapy or ifosfamide; or intraarterial radiographic contrast with two or more high-risk nephrotoxic medication exposures per NINJA criteria
- Able to provide informed consent or have an authorized representative available to give written consent after being informed about the study
You will not qualify if you...
- Stage 3 acute kidney injury based on KDIGO serum creatinine or urine output criteria, or receiving short-term dialysis
- Category G5 chronic kidney disease (eGFR less than 15 mL/min/1.73 m2), maintenance dialysis, or kidney transplant
- Pregnancy or lactation
- Known allergy to imipenem-cilastatin
- Treatment with imipenem-cilastatin within 48 hours prior to enrollment
- Treatment with probenecid within 48 hours prior to enrollment
- Participation in another interventional study or treatment with another investigational drug within 30 days
- Unable to comply with study protocol requirements
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Actively Recruiting
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Actively Recruiting
Research Team
N
Nusrat S Shommu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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