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

iCoat Medical

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Kidney Transplant; Complications; Ischemia-reperfusion Injury

Treatments: Drug: iCM012 solution 2 mg/mL; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06582485

EMPIRe

2024-513990-33-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

Randomized (1:1), placebo controlled, double blind efficacy trial. 200 patients will be followed up for 12 months post transplantation. The primary endpoint will be Delayed Graft Function (DGF) defined as the requirement for dialysis within 7 days post transplantation.

Full description

The present trial aims to evaluate if iCM012 solution 2 mg/mL can improve short and mid-term allograft function of controlled donation after circulatory death (DCD) kidneys at high risk for Ischemia Reperfusion Injury (IRI) -induced graft dysfunction as assessed by primarily DGF and secondary as estimated glomerular filtration rates (eGFR). The trial will also generate additional efficacy, safety, and exploratory data.

Enrollment: 200 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

200 participants in 2 patient groups, including a placebo group

Active treatment iCM012 solution 2 mg/mL

Experimental group

Description:

iCM012 solution 2 mg/mL - 200 mL Investigational Medicinal Product (IMP) solution is administered ex vivo by gravity as single infusion through the renal artery/-ies over a period of 5-10 minutes.

Treatment:

Drug: iCM012 solution 2 mg/mL

Placebo

Placebo Comparator group

Description:

Placebo - 200 mL IMP solution is administered ex vivo by gravity as single infusion through the renal artery/-ies over a period of 5-10 minutes.

Treatment:

Drug: Placebo