Cilastatin for Acute Kidney Injury
(PONTiAK Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you are actively receiving certain nephrotoxic medications. If you are taking imipenem-cilastatin or probenecid, you must stop at least 48 hours before joining the trial.
How does the drug cilastatin differ from other treatments for acute kidney injury?
Cilastatin is unique because it protects the kidneys from damage caused by certain drugs like gentamicin and cisplatin without affecting their effectiveness. It works by preventing harmful substances from entering kidney cells and reducing cell damage, making it a novel option for preventing drug-induced kidney injury.12345
What is the purpose of this trial?
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
Research Team
Matthew T James, MD
Principal Investigator
University of Calgary
Eligibility Criteria
This trial is for hospitalized patients at risk of acute kidney injury due to nephrotoxic medications. Participants must be able to receive intravenous treatments and commit to daily blood tests for kidney function, a follow-up test, and a telephone survey 90 days after starting the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive IV cilastatin or placebo every 6 hours for up to 24 hours after last exposure to nephrotoxic medication
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a follow-up blood test and telephone survey at 90 days after randomization
Extended Follow-up
Participants' major adverse kidney and cardiovascular outcomes are monitored via administrative data linkage
Treatment Details
Interventions
- Cilastatin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Matthew James
Lead Sponsor
Alberta Health services
Collaborator
University of Alberta
Collaborator