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Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin
Sponsor: Matthew James
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 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
Official title: The Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin (PONTiAK) Trial: A Phase 2B Vanguard Design, Randomized, Double-Blind, Placebo-Controlled Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
698
Start Date
2025-07-16
Completion Date
2029-12
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
Cilastatin Sodium
Intravenous cilastatin reconstituted in normal saline solution
Placebo-Saline
Identical looking normal saline solution
Locations (2)
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada