Ischemia-reperfusion InjuryPhase 1/2NCT05246618
FIH Phase I/IIa Trial Evaluating Safety of TUM012 to Minimize Ischemic Reperfusion Injury in Kidney Transplantation
A Phase 1/2 study testing TUM012 in people with Ischemia-reperfusion Injury and Kidney Transplant; Complications, run by iCoat Medical AB at 1 site in Sweden.
Trial summary
A first-in-human single center, randomized, double-blind, placebo-controlled trial, with primary objective to evaluate safety and tolerability of ex-vivo kidney allograft treatment with TUM012 to reduce ischemia-reperfusion injury in de novo kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia-reperfusion Injury, Kidney Transplant; Complications
- What is being tested?
- TUM012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 31 Mar 2022to 14 May 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Standard and extended criteria donor ≥18 years of age, suitable for clinical transplantation and preserved by cold storage.
- Available, personally signed and dated Informed Consent Form (ICF)
- Male or female Chronic Kidney Disease (CKD) patient ≥18 years of age, with Glomerular Filtration Rate (GFR) ≤15 mL/min, awaiting their first kidney transplantation
- ABO-compatible, negative pre-transplant CDC class I and II crossmatch with no Donor Specific Antibodies (DSA), defined as ≤1 000 Mean Fluorescent Intensity (MFI).
- Patient is suitable for surgery, as judged by the investigator
- Completed vaccination program for pneumococcal disease, varicella zoster, measles, and SARS-CoV-2 virus
Who cannot join
- Surgically induced injuries compromising ex-vivo treatment and/or transplant outcome, as judged by the transplantation surgeon
- Previously undergone any organ and/or cell transplantations
- Patients with positive CDC class I and/or II crossmatch, or negative CDC class I and II crossmatch with pre-existing DSA > 1,000 MFI
- ABO-incompatible DD KT
- Pregnant or breast-feeding woman
- Woman of child-bearing potential, unwilling to use an adequate contraceptive method
Show all 13Show fewer
- Prior participation in clinical trial with (approved or non-approved) IMP within one month prior to screening for this trial.
- Prior malignancy diagnosis ≤5 years, except for adequately treated basal cell, or squamous cell skin cancer, and cervical carcinoma in situ
- Positive result for serum Human Immunodeficiency Virus (HIV), active hepatitis B-, or C-infection in pre-transplant evaluation
- Clinical signs of ongoing infectious disease, defined as C-Reactive Protein (CRP) >10, unless stable since >4 weeks (<50% increase)
- Concomitant severe conditions requiring treatment and close monitoring, e.g., cardiac failure >grade 3 New York Heart Association (NYHA), unstable coronary disease, or oxygen dependent Chronic Obstructive Pulmonary Disease (COPD)
- 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
- Patient unlikely to comply with trial procedures, restrictions, and requirements (e.g., caused by substance abuse, concurrent medical condition, etc.), as judged by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I FIH Phase I/IIa Randomized Placebocontrolled Doubleblind Trial Evaluating Safety and Tolerability of ExVivo Deceased Donor Kidney Allograft Treatment With TUM012 to Minimize Ischemic Reperfusion Injury After Kidney Transplantation
A first-in-human single center, randomized, double-blind, placebo-controlled trial, with primary objective to evaluate safety and tolerability of ex-vivo kidney allograft treatment with TUM012 to reduce ischemia-reperfusion injury in de novo kidney transplant recipients.
Read the detailed description
Graft ischemia and reperfusion related injury is still the leading cause of graft failure in Deceased Donor kidney transplantation. The aim of the trial is to evaluate the safety of ex-vivo treatment of kidney allografts from deceased-donors with TUM012 to diminish ischemia reperfusion related inflammation, and improve overall transplantat outcome.
- Being tested
- TUM012, Placebo
- Keywords
- Ex-vivo kidney allograft treatment, Transplant outcome
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUM012Drug
Also called Ex-vivo infusion
Ex-vivo infusion
PlaceboDrug
Also called Ex-vivo infusion
Ex-vivo infusion
| Study group | Role | What they receive |
|---|---|---|
| TUM012 | Experimental | Ex-vivo infusion Receives: Drug: TUM012 |
| Placebo | Placebo comparator | Ex-vivo infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of patients with confirmed IMP-related events
Measured: Three months from randomization
Laboratory Analyses (Standard of Care Safety)
Assessment: "normal", "abnormal, not clinically significant", or "abnormal, clinically significant", will as appropriate be reported as Adverse Events.
Measured: Three months from randomization
12-lead Electro-Cardiogram (Standard of Care Safety)
Assessment: "normal", "abnormal, not clinically significant", or "abnormal, clinically significant"
Measured: Three months from randomization
Systolic/diastolic BP (Standard of Care Safety)
Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"
Measured: Three months from randomization
Pulse Rate (Standard of Care Safety)
Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"
Measured: Three months from randomization
Peripheral blood oxygenation (Standard of Care Safety)
Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"
Measured: Three months from randomization
Body temperature (Standard of Care Safety)
Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"
Measured: Three months from randomization
Secondary outcomes (7)
Exploratory histological evaluation of kidney graft
Biopsy
Measured: Three months from randomization
Exploratory kidney graft function
Number
Measured: Three months from randomization
Exploratory Efficacy: Proteomics
Changed levels from baseline.
Measured: Three months from randomization
Exploratory Efficacy: Markers of IR injury and thromboinflammation plasma level
Changed levels from baseline.
Measured: Three months from randomization
Exploratory Efficacy: Cytokine release plasma level
Changed levels from baseline.
Measured: Three months from randomization
Exploratory Efficacy: Immune cell graft recruitment plasma level
Changed levels from baseline.
Measured: Three months from randomization
Exploratory Efficacy: Pharmacokinetics plasma concentration
Changed levels from baseline.
Measured: Three months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start31 Mar 2022
- Primary completion31 Jul 2023
- Study completion14 May 2024
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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- iCoat Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB, Region Skane
- Responsible party
- Sponsor
- Investigators
- Ingegerd Dalfelt, Study director, iCoat Medical AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246618
- Sponsor's protocol ID
- ATMIRe
- Status last verified
- Jun 2024
- First submitted
- 28 Nov 2021
- Last updated
- 4 Jun 2024
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I FIH Phase I/IIa Randomized Placebocontrolled Doubleblind Trial Evaluating Safety and Tolerability of ExVivo Deceased Donor Kidney Allograft Treatment With TUM012 to Minimize Ischemic Reperfusion Injury After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT05246618
- Acronym / sponsor ID
- ATMIRe
- Keywords
- Ex-vivo kidney allograft treatment, Transplant outcome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- iCoat Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB, Region Skane
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 18 Feb 2022 (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.
A first-in-human single center, randomized, double-blind, placebo-controlled trial, with primary objective to evaluate safety and tolerability of ex-vivo kidney allograft treatment with TUM012 to reduce ischemia-reperfusion injury in de novo kidney transplant recipients.
Detailed description
Graft ischemia and reperfusion related injury is still the leading cause of graft failure in Deceased Donor kidney transplantation. The aim of the trial is to evaluate the safety of ex-vivo treatment of kidney allografts from deceased-donors with TUM012 to diminish ischemia reperfusion related inflammation, and improve overall transplantat outcome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TUM012 | Experimental | Drug: TUM012Ex-vivo infusion |
| Placebo | Placebo comparator | Drug: PlaceboEx-vivo infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Standard and extended criteria donor ≥18 years of age, suitable for clinical transplantation and preserved by cold storage.
- Available, personally signed and dated Informed Consent Form (ICF)
- Male or female Chronic Kidney Disease (CKD) patient ≥18 years of age, with Glomerular Filtration Rate (GFR) ≤15 mL/min, awaiting their first kidney transplantation
- ABO-compatible, negative pre-transplant CDC class I and II crossmatch with no Donor Specific Antibodies (DSA), defined as ≤1 000 Mean Fluorescent Intensity (MFI).
- Patient is suitable for surgery, as judged by the investigator
Key exclusion criteria (13 listed)
- Surgically induced injuries compromising ex-vivo treatment and/or transplant outcome, as judged by the transplantation surgeon
- Previously undergone any organ and/or cell transplantations
- Patients with positive CDC class I and/or II crossmatch, or negative CDC class I and II crossmatch with pre-existing DSA > 1,000 MFI
- ABO-incompatible DD KT
- Pregnant or breast-feeding woman
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 |
|---|---|---|
| TUM012Also: Ex-vivo infusionEx-vivo infusion | Drug | TUM012 |
| PlaceboAlso: Ex-vivo infusionEx-vivo infusion | Drug | Placebo |
Primary outcome
Adverse Events
Time frame: Three months from randomization
Number of patients with confirmed IMP-related events
Laboratory Analyses (Standard of Care Safety)
Time frame: Three months from randomization
Assessment: "normal", "abnormal, not clinically significant", or "abnormal, clinically significant", will as appropriate be reported as Adverse Events.
12-lead Electro-Cardiogram (Standard of Care Safety)
Time frame: Three months from randomization
Assessment: "normal", "abnormal, not clinically significant", or "abnormal, clinically significant"
Systolic/diastolic BP (Standard of Care Safety)
Time frame: Three months from randomization
Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"
Pulse Rate (Standard of Care Safety)
Time frame: Three months from randomization
Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"
Peripheral blood oxygenation (Standard of Care Safety)
Time frame: Three months from randomization
Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"
Body temperature (Standard of Care Safety)
Time frame: Three months from randomization
Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"
7 secondary outcomes
Exploratory histological evaluation of kidney graft
Time frame: Three months from randomization
Exploratory kidney graft function
Time frame: Three months from randomization
Exploratory Efficacy: Proteomics
Time frame: Three months from randomization
Exploratory Efficacy: Markers of IR injury and thromboinflammation plasma level
Time frame: Three months from randomization
Exploratory Efficacy: Cytokine release plasma level
Time frame: Three months from randomization
Exploratory Efficacy: Immune cell graft recruitment plasma level
Time frame: Three months from randomization
Exploratory Efficacy: Pharmacokinetics plasma concentration
Time frame: Three months from randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- 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. This study is not recruiting at the moment.
Ingegerd Dalfelt study director
iCoat Medical AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TUM012 in people with Ischemia-reperfusion Injury and Kidney Transplant; Complications, run by iCoat Medical AB at 1 site in Sweden.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Three months from randomization). The study lists 7 primary outcomes in all. 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 4 Jun 2024.