A Trial to Assess Efficacy and Safety of ex Vivo Allograft Admin of iCM012 Solution 2 mg/ml to Improve Its Function in Recipients of DCD Kidneys

Launched by ICOAT MEDICAL AB · Aug 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called iCM012, which is being tested to see if it can help improve the function of kidneys that come from donors after they have died (called DCD kidneys) and which may be at risk of injury during the transplant process. The trial will involve 200 patients who are waiting for their first kidney transplant and have been on dialysis for at least 12 months. Participants must be at least 18 years old and will be monitored for one year after their transplant to see if this treatment can prevent a common complication known as Delayed Graft Function, which happens when the new kidney doesn't work right away and the patient needs dialysis within the first week.

To be eligible for this trial, potential participants must meet certain criteria, such as having a compatible blood type and no serious pre-existing conditions that might complicate the transplant. They should not have had any previous organ transplants or certain severe diseases. If chosen to participate, patients will receive either the iCM012 treatment or a placebo (a substance with no active treatment) without knowing which one they have, as this is a randomized trial. It's important to note that the trial is not yet recruiting participants, so those interested will need to wait for updates on when enrollment begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• To be eligible for use in this trial, an allograft must meet the following criterion:
• • 1. Controlled DCD donors Maastricht category III from 55 to 75 years of age.
• To be eligible to participate in this trial, a patient must meet all the following criteria:
• • 2. Available, personally signed and dated Informed Consent Form.
• • 3. Male or female chronic kidney disease (CKD) ≥ 18 years of age, on dialysis \> 12 months, awaiting their first kidney transplantation.
• • 4. AB0-compatible, negative pre-transplantation Complement Dependent Cytotoxicity (CDC) and/or flow cytometric class I and II crossmatch, or negative virtual class I and II crossmatch, and no pre-existing donor specific antibodies (Mean Fluorescent Intensity under center specific cut-off for negative value).
• • 5. Completed vaccination program according to local standard practice or as deemed relevant by the investigator.
• Exclusion Criteria:
• An allograft that meets any of the following criteria will be excluded from use in this trial:
• • 1. Surgically induced injuries or anatomical vascular variations compromising ex vivo treatment and/or transplantation outcome, as judged by the investigator.
• • 2. DCDs with persistent and significant deterioration of kidney function (30% decrease in eGFR from baseline) and/or on dialysis within two (2) weeks prior to organ procurement and/or anuria \> 12 hours before surgery.
• • 3. Extracorporeal membrane oxygenation treatment of the donor
• A patient who meets any of the following criteria will be excluded from participation in this trial:
• • 4. If not tolerating/eligible for thymoglobulin induction and tacrolimus or Cyclosporine A (CyA)-based maintenance immunosuppressants.
• • 5. Previously undergone any organ and/or cell transplantations.
• • 6. Positive CDC and or flow cytometric class I and/or II crossmatch, and/or positive virtual crossmatch.
• • 7. Highly sensitized patients defined by Panel Reactive Antibody (PRA) level equal or higher than 98%.
• • 8. AB0-incompatible deceased donor kidney transplantation.
• • 9. Pregnant or breast-feeding woman.
• • 10. Woman of child-bearing potential, not using an adequate contraceptive method.
• • 11. Prior participation in a clinical trial with (approved or non-approved) IMPs within 1 month prior to screening for this trial.
• • 12. Prior malignancy diagnosis ≤ 5 years, except for adequately treated basal cell, or squamous cell skin cancer, and carcinoma in situ, or judged as irrelevant by the investigator.
• • 13. Positive result for serum human immunodeficiency virus (HIV), active hepatitis B or C infection in pre-transplantation evaluation.
• • 14. History of severe drug allergy or hypersensitivity, or known hypersensitivity, or intolerance to any of the IMPs or its/their excipients.
• • 15. Concomitant severe conditions requiring treatment and close monitoring, as judged by the investigator.
• • 16. History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the trial, or influence the results or the patient's ability to participate in the trial.
• • 17. Unlikely to comply with trial procedures, restrictions, and requirements (e.g., caused by substance abuse, concurrent medical condition, etc.), as judged by the investigator.