RecruitingPHASE2INTERVENTIONAL

Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin

This study aims to discover if a medication called cilastatin can prevent acute kidney injury (AKI) in hospitalised patients who are receiving other strong medications. Some medicines, used for serious conditions like cancer or infections, can unfortunately damage the kidneys. Currently, there isn't a good way to prevent this kidney damage other than avoiding these important medicines, which isn't always possible. Researchers will give some patients cilastatin and others a 'dummy' medicine (called a placebo) to see if cilastatin protects the kidneys. The study will check kidney health with blood tests and follow up with patients for 90 days. We hope this research will lead to new ways to keep kidneys healthy during hospital stays.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Matthew James

Enrolment target

698

Start

16 Jul 2025

Estimated completion

01 Dec 2029

Acute Kidney Injury

What is this study about?

When you're in the hospital, especially for serious conditions, you might need strong medications. Sometimes, these medications, which are very important for your health, can unfortunately cause a problem called acute kidney injury (AKI). This means your kidneys suddenly stop working as well as they should. AKI can lead to longer hospital stays and serious health issues later on, including a higher risk of developing long-term kidney problems.

Currently, doctors don't have a specific medicine to prevent AKI caused by other necessary treatments. This means that sometimes, to protect your kidneys, doctors might have to limit or change important medications, which isn't ideal. This study is exploring a new approach, looking at an existing medicine called cilastatin to see if it can offer protection.

Researchers want to see if cilastatin can act like a shield for your kidneys against the effects of these strong medications. By comparing cilastatin to a placebo (a substance that looks the same but contains no medicine), they hope to find out if it's effective in preventing AKI. Finding a way to protect kidneys like this would be a big step forward and could help many patients avoid serious complications and enjoy better long-term health. This particular study is in an early stage (Phase 2), meaning it's still testing if the treatment works and is safe.

Key takeaways

New study to prevent kidney damage in hospital.
Tests if cilastatin can protect kidneys from medications.
Compares cilastatin to a dummy medicine (placebo).
Involves blood tests and a 90-day follow-up.
Aims to improve care for hospitalised patients.

Who may be eligible?

To be able to take part in this study, you generally need to be an adult (18 years or older) and currently receiving certain medications in hospital that are known to sometimes harm the kidneys. These can include specific antibiotics, drugs used after organ transplants, or some cancer treatments.

You would not be able to join if you already have serious kidney damage, are on dialysis, or have had a kidney transplant. You also can't take part if you are pregnant or breastfeeding, or if you've recently taken certain other medications that could affect the study results, including cilastatin itself. Your doctor will carefully check all your current health conditions and medicines to make sure this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently in hospital and taking certain strong medications that could affect your kidneys?
Do you *not* have severe kidney disease or are on dialysis?
Are you *not* pregnant or breastfeeding?
Have you *not* recently taken cilastatin or certain other related medications?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be given either the study medicine, cilastatin, or a dummy medicine called a placebo. You won't know which one you're getting, nor will your doctors, until the end of the study. This medicine will be given into your vein (intravenously) every 6 hours, for up to 24 hours after you've had your last dose of the kidney-harming medication.

Throughout your treatment period, you will have daily blood tests to check how well your kidneys are working. After you've finished receiving the study medicine, there will be a follow-up. This includes another blood test to check your kidney function about 90 days later, and a short phone call around the same time to see how you're doing. The total duration of active treatment with the study drug is short, but the follow-up ensures we understand any longer-term effects on kidney health.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The main potential benefit for you might be that cilastatin could help protect your kidneys from damage caused by other important medications. However, it's also possible you could be in the placebo group and not receive the active drug, or that cilastatin may not work for everyone. There might be side effects from cilastatin, though these will be carefully monitored. The research team will explain all known potential side effects. Please remember that taking part is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

University of Calgary
Verified postcode
Calgary, Canada· Recruiting
University of Alberta
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is 'acute kidney injury'?

It's when your kidneys suddenly stop working as well as they should, often due to illness or certain medicines.

What is cilastatin and why are they using it?

Cilastatin is a medicine that's been around for other uses. Researchers are now testing if it can protect kidneys from harm caused by strong medications.

Will I know if I'm getting the real medicine or a dummy one?

No, neither you nor your doctor will know during the study. This is common in trials to make sure results are fair and accurate.

How long will I be in the study?

You'll receive treatment for a short period (up to 24 hours), but there will be follow-up checks, including a blood test and phone call, about 90 days later.

What if I change my mind about taking part?

You can leave the study at any time, for any reason, and your medical care will not be affected.

How to find out more

Nusrat S Shommu, PhD

nsshommu@ucalgary.ca 4032103991 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.