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

NCT06582485 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: EMPIRe2024-513990-33-00
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ischemia-reperfusion Injury; Kidney Transplant; Complications

Keywords

Ex-vivo kidney allograft treatment; kidney transplantation; Transplant outcome; Ischemia-reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• Delayed Graft Function (DGF)

  DGF is defined as the need for dialysis within the first 7 postoperative days.

  First 7 postoperative days.

Secondary Outcomes (10)

• eGFR over 12 months post transplantation

  12 months post transplantation

• Primary non-function

  12 months post transplantation

• Number of Participants with prolonged DGF

  14 days post transplantation

• Number of Participants with functional DGF

  First 7 days post-transplantation

• Duration of dialysis sessions (hours)

  First 30- and 90-days post-transplantation

Study Arms (2)

Active treatment iCM012 solution 2 mg/mL

EXPERIMENTAL

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.

Drug: iCM012 solution 2 mg/mL

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

iCM012 solution 2 mg/mL DRUG

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.

Active treatment iCM012 solution 2 mg/mL

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iCoat Medical AB: lead

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ingegerd Dalfelt

  iCoat Medical

  STUDY CHAIR

Central Study Contacts

Ingegerd Dalfelt

CONTACT

46708433348; ingegerd.dalfelt@icoatmedical.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 3, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After End of Trial
• Access Criteria: Individual participant data (IPD) collected in this study will be made available to participating trial patients through the investigational site and to the public through publications, as well as on the company website.