NCT06886464 Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin
| NCT ID | NCT06886464 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Matthew James |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 698 participants |
| Start Date | 2025-07-16 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 698 participants in total. It began in 2025-07-16 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Matthew T James, MD
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT06886464 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06886464 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06886464 currently recruiting?
Yes, NCT06886464 is actively recruiting participants. Contact the research team at nsshommu@ucalgary.ca for enrollment information.
Where is the NCT06886464 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada.
Who is sponsoring the NCT06886464 clinical trial?
NCT06886464 is sponsored by Matthew James. The principal investigator is Matthew T James, MD at University of Calgary. The trial plans to enroll 698 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.