RecruitingPhase 2NCT06886464

Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin

The Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin (PONTiAK) Trial: A Phase 2B Vanguard Design, Randomized, Double-Blind, Placebo-Controlled Study


Sponsor

Matthew James

Enrollment

698 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cilastatin Sodium and a drug called Placebo-Saline for people with acute kidney injury. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCilastatin Sodium

Intravenous cilastatin reconstituted in normal saline solution

DRUGPlacebo-Saline

Identical looking normal saline solution


Locations(2)

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

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NCT06886464


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