Ischemia-reperfusion InjuryPhase 2/3NCT06582485
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
A Phase 2/3 study testing iCM012 solution 2 mg/mL in people with Ischemia-reperfusion Injury and Kidney Transplant; Complications, run by iCoat Medical AB.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Ischemia-reperfusion Injury, Kidney Transplant; Complications
- What is being tested?
- iCM012 solution 2 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Being tested
- iCM012 solution 2 mg/mL, Placebo
- Keywords
- Ex-vivo kidney allograft treatment, kidney transplantation, Transplant outcome, Ischemia-reperfusion Injury
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCM012 solution 2 mg/mLDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Graft Function (DGF)
DGF is defined as the need for dialysis within the first 7 postoperative days.
Measured: First 7 postoperative days.
Secondary outcomes (10)
eGFR over 12 months post transplantation
Estimated Glomerular Filtration Rate using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation with four (4) variables (serum creatinine, age, gender, and ethnicity)
Measured: 12 months post transplantation
Primary non-function
Primary non-function (PNF) describes the condition in which the kidney never functions adequately after transplantation, and the patient continues to need dialysis despite the transplantation. The diagnosis of PNF generally does not become established before 2 to 3 months after transplantation. Assessed up to 12 months after transplantation
Measured: 12 months post transplantation
Number of Participants with prolonged DGF
Number of Participants with prolonged DGF (defined as requirement for dialysis more than 14 days post transplantation)
Measured: 14 days post transplantation
Number of Participants with functional DGF
Number of Participants with functional DGF (defined as no serum creatinine decrease by at least 10% daily on 3 consecutive days within the first 7 days post-transplantation)
Measured: First 7 days post-transplantation
Duration of dialysis sessions (hours)
Duration of dialysis sessions within the first 30- and 90-days post-transplantation. Measured in hours.
Measured: First 30- and 90-days post-transplantation
Number of dialysis sessions
Number of dialysis sessions within the first 30- and 90-days post-transplantation
Measured: First 30- and 90-days post-transplantation
Changes in Quality of Life
Quality of Life EuroQol - five dimensions - three levels (EQ-5D-3L) Assessed through standardized questionnaires, results combined to single summary index (0-1: 0 is death, 1 is perfect health).
Measured: 12 months post transplantation
Incidence of de novo Human Leukocyte Antigen (HLA) antibodies within 12 months
Incidence of de novo Human Leukocyte Antigen antibodies within 12 months
Measured: 12 months post transplantation
Incidence of biopsy-proven allograft rejection within 12 months
Incidence of biopsy-proven allograft rejection within 12 months
Measured: 12 months post transplantation
Tubular cell injury assessed by exploratory urinary biomarkers
Tubular cell injury assessed by exploratory urinary biomarkers; details not yet decided.
Measured: 12 months post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia-reperfusion InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iCoat Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingegerd Dalfelt, Study chair, iCoat Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582485
- Sponsor's protocol ID
- EMPIRe
- Other IDs
- 2024-513990-33-00
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06582485
- Acronym / sponsor ID
- EMPIRe
- Keywords
- Ex-vivo kidney allograft treatment, kidney transplantation, Transplant outcome, Ischemia-reperfusion Injury
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- iCoat Medical ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment iCM012 solution 2 mg/mL | Experimental | Drug: iCM012 solution 2 mg/mLiCM012 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo - 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (19 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCM012 solution 2 mg/mL200 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 | Active treatment iCM012 solution 2 mg/mL |
| Placebo200 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 |
Primary outcome
Delayed Graft Function (DGF)
Time frame: First 7 postoperative days.
DGF is defined as the need for dialysis within the first 7 postoperative days.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ingegerd Dalfelt study chair
iCoat Medical
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing iCM012 solution 2 mg/mL in people with Ischemia-reperfusion Injury and Kidney Transplant; Complications, run by iCoat Medical AB.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingegerd Dalfelt (46708433348, ingegerd.dalfelt@icoatmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed Graft Function (DGF) (time frame: First 7 postoperative days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.