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RECRUITING
NCT06886464
PHASE2

Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin

Sponsor: Matthew James

View on ClinicalTrials.gov

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

Interventions

DRUG

Cilastatin Sodium

Intravenous cilastatin reconstituted in normal saline solution

DRUG

Placebo-Saline

Identical looking normal saline solution

Locations (2)

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada