Using cilastatin to prevent kidney damage from certain hospital medications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 randomized, placebo-controlled trial gives hospitalized adults either intravenous cilastatin or a saline placebo every six hours while they are exposed to eligible nephrotoxic drugs and for up to 24 hours after the last exposure. Kidney function will be monitored with daily blood tests during treatment and a follow-up blood test at 90 days, plus a 90-day telephone check-in. The trial targets patients receiving agents such as IV vancomycin, aminoglycosides, calcineurin inhibitors, platinum chemotherapies, or high-risk contrast exposure. The main goal is to see if cilastatin reduces the incidence of nephrotoxin-associated acute kidney injury compared with placebo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Active treatment with an eligible nephrotoxic medication- IV vancomycin, IV aminoglycoside (gentamicin or tobramycin), IV calcineurin inhibitor (cyclosporine or tacrolimus), or IV or intraperitoneal platin-based chemotherapy or ifosfamide; or intraarterial radiographic contrast with two or more high-risk nephrotoxic medication exposures according to the NINJA algorithm.
* Able to provide informed consent or have an authorized representative available and willing to give written informed consent after being properly informed of the nature and risks of the Study.

Exclusion Criteria:

* Stage 3 AKI based on Kidney Disease Improving Global Outcomes (KDIGO) SCr or urine output criteria, or receipt of short-term dialysis.
* Category G5 CKD (defined as a CKD-EPI eGFR or \<15 mL/min/1.73 m2) or being treated with maintenance dialysis or a kidney transplant.
* Pregnancy or lactation
* Known hypersensitivity to imipenem-cilastatin.
* Active or recent treatment (within 48 hours) with imipenem-cilastatin
* Active or recent treatment (within 48 hours) with probenecid (medication used for gout prevention that inhibits cilastatin excretion and decreases plasma clearance)
* Treatment with another investigational medicinal product or participation in another interventional Study within 30 days
* Inability to comply with the requirements of the Study protocol.

Where it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting
• University of Alberta
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Matthew T James, MD — University of Calgary
• Study coordinator: Nusrat S Shommu, PhD
• Email: nsshommu@ucalgary.ca
• Phone: 4032103991

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Remote Ischemic Preconditioning at Different Times After Heart Valve Surgery

  This study tests whether applying brief, controlled blood-flow restrictions to a limb at different times after heart valve surgery can help protect organs and reduce complications like kidney injury.

  Recruiting Fujian Medical University Union Hospital · Fuzhou, Fujian · NCT07888634

• Clinical decision support to help consider SGLT2 inhibitors after AKI in type 2 diabetes

  This pilot test checks if a CDS message given to clinicians can help decide whether to consider SGLT2 inhibitors for adults with type 2 diabetes who recently had acute kidney injury.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT07868666

• Biomarkers to predict CSA-AKI risk before heart surgery

  This study tests new biomarkers to see if they can predict CSA-AKI risk in adults undergoing cardiovascular surgery.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT07811570

• Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter

  This trial tests whether using the oXiris hemofilter during continuous kidney replacement helps lower endotoxin levels in adults with septic shock who need CRRT.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07807410

• Perioperative GFR Monitoring to Predict CSA-AKI and CA-AKI

  This study tests whether perioperative transcutaneous fluorescence GFR measurements can predict CSA-AKI or CA-AKI in adults undergoing cardiovascular procedures or iodine contrast exposure.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT07749417

• Restarting RAS inhibitors after AKI: a quick test in hospitalized adults

  This pilot study tests whether restarting renin-angiotensin system inhibitors early after acute kidney injury is feasible and safe in hospitalized adults already using these medicines.

  Recruiting Phase 4 University of California, San Francisco · San Francisco, California · NCT07734636

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.