Recruiting
Phase 2

Cilastatin

Sponsor:

Matthew James

Code:

NCT06886464

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cilastatin Sodium

Placebo-Saline

Study Details

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

Conditions

Acute Kidney Injury

Study ID

NCT06886464

Start date

Jul 16, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

698 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cilastatin Intervention

Patients in this Arm will receive the Investigational Medicinal Product- Cilastatin

placebo comparator: Placebo Control

Patients in this Arm will receive placebo

Interventions

Cilastatin Sodium

Intravenous cilastatin reconstituted in normal saline solution

Placebo-Saline

Identical looking normal saline solution

Primary outcome measure

  • Number of participants developing AKI [ Time Frame: 7 days after administration of a nephrotoxic medication ]

Central Contacts and Locations

Central contacts

Nusrat S Shommu, PhD

4032103991nsshommu@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2R3

Contacts

Eila Mirhadi, MSc

7802387535mirhadi@ualberta.ca

More Information

Sponsor

Matthew James

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • Acute Kidney Injury
  • Nephrotoxic
  • Cilastatin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Matthew James on 2025-11-26.