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Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin

NCT06886464 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 698

Last updated 2025-11-26

No results posted yet for this study

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

Interventions

DRUG

Cilastatin Sodium

Intravenous cilastatin reconstituted in normal saline solution

DRUG

Placebo-Saline

Identical looking normal saline solution

Sponsors & Collaborators

  • Alberta Health services

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • Matthew James

    lead OTHER

Principal Investigators

  • Matthew T James, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06886464 on ClinicalTrials.gov