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Not yet recruiting NCT06582485

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

Phase II / Phase III Interventional Ischemia-reperfusion Injury Kidney Transplant; Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iCM012 solution 2 mg/mL, Placebo.
Who it may be relevant to
Registry conditions: Ischemia-reperfusion Injury, Kidney Transplant; Complications. Basic parameters: 55 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Placebo-controlled, Double-blind Phase 2b Trial to Assess the Efficacy and Safety of ex Vivo Allograft Admin of iCM012 Solution 2 mg/mL to Improve Allograft Function in Recipients of Donation After Circulatory Death Kidneys

Overview

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.

Detailed 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.

Interventions

  • Drug iCM012 solution 2 mg/mL
    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.
  • Drug 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.

Primary outcome measures

  • Delayed Graft Function (DGF) [Time frame: First 7 postoperative days.]
Secondary outcome measures (10)
  • eGFR over 12 months post transplantation [Time frame: 12 months post transplantation]
  • Primary non-function [Time frame: 12 months post transplantation]
  • Number of Participants with prolonged DGF [Time frame: 14 days post transplantation]
  • Number of Participants with functional DGF [Time frame: First 7 days post-transplantation]
  • Duration of dialysis sessions (hours) [Time frame: First 30- and 90-days post-transplantation]
  • Number of dialysis sessions [Time frame: First 30- and 90-days post-transplantation]
  • Changes in Quality of Life [Time frame: 12 months post transplantation]
  • Incidence of de novo Human Leukocyte Antigen (HLA) antibodies within 12 months [Time frame: 12 months post transplantation]
  • Incidence of biopsy-proven allograft rejection within 12 months [Time frame: 12 months post transplantation]
  • Tubular cell injury assessed by exploratory urinary biomarkers [Time frame: 12 months post transplantation]

Eligibility criteria

Inclusion criteria

To be eligible for use in this trial, an allograft must meet the following criterion:

  • 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:

  • Available, personally signed and dated Informed Consent Form.
  • Male or female chronic kidney disease (CKD) ≥ 18 years of age, on dialysis \> 12 months, awaiting their first kidney transplantation.
  • 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).
  • 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:

  • Surgically induced injuries or anatomical vascular variations compromising ex vivo treatment and/or transplantation outcome, as judged by the investigator.
  • 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.
  • Extracorporeal membrane oxygenation treatment of the donor

A patient who meets any of the following criteria will be excluded from participation in this trial:

  • If not tolerating/eligible for thymoglobulin induction and tacrolimus or Cyclosporine A (CyA)-based maintenance immunosuppressants.
  • Previously undergone any organ and/or cell transplantations.
  • Positive CDC and or flow cytometric class I and/or II crossmatch, and/or positive virtual crossmatch.
  • Highly sensitized patients defined by Panel Reactive Antibody (PRA) level equal or higher than 98%.
  • AB0-incompatible deceased donor kidney transplantation.
  • Pregnant or breast-feeding woman.
  • Woman of child-bearing potential, not using an adequate contraceptive method.
  • Prior participation in a clinical trial with (approved or non-approved) IMPs within 1 month prior to screening for this trial.
  • 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.
  • Positive result for serum human immunodeficiency virus (HIV), active hepatitis B or C infection in pre-transplantation evaluation.
  • History of severe drug allergy or hypersensitivity, or known hypersensitivity, or intolerance to any of the IMPs or its/their excipients.
  • Concomitant severe conditions requiring treatment and close monitoring, as judged by the investigator.
  • 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.
  • Unlikely to comply with trial procedures, restrictions, and requirements (e.g., caused by substance abuse, concurrent medical condition, etc.), as judged by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06582485 · EMPIRe · 2024-513990-33-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗