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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05246618
Other study ID # ATMIRe
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 31, 2022
Est. completion date May 14, 2024

Study information

Verified date June 2024
Source iCoat Medical AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date May 14, 2024
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Study Design


Intervention

Drug:
TUM012
Ex-vivo infusion
Placebo
Ex-vivo infusion

Locations

Country Name City State
Sweden Skane University Hospital Malmö

Sponsors (3)

Lead Sponsor Collaborator
iCoat Medical AB CTC Clinical Trial Consultants AB, Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient survival Number One year from randomization
Other Incidence of graft rejection Number One year from randomization
Other Graft survival Number One year from randomization
Primary Adverse Events Number of patients with confirmed IMP-related events Three months from randomization
Primary Laboratory Analyses (Standard of Care Safety) Assessment: "normal", "abnormal, not clinically significant", or "abnormal, clinically significant", will as appropriate be reported as Adverse Events. Three months from randomization
Primary 12-lead Electro-Cardiogram (Standard of Care Safety) Assessment: "normal", "abnormal, not clinically significant", or "abnormal, clinically significant" Three months from randomization
Primary Systolic/diastolic BP (Standard of Care Safety) Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant" Three months from randomization
Primary Pulse Rate (Standard of Care Safety) Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant" Three months from randomization
Primary Peripheral blood oxygenation (Standard of Care Safety) Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant" Three months from randomization
Primary Body temperature (Standard of Care Safety) Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant" Three months from randomization
Secondary Exploratory histological evaluation of kidney graft Biopsy Three months from randomization
Secondary Exploratory kidney graft function Number Three months from randomization
Secondary Exploratory Efficacy: Proteomics Changed levels from baseline. Three months from randomization
Secondary Exploratory Efficacy: Markers of IR injury and thromboinflammation plasma level Changed levels from baseline. Three months from randomization
Secondary Exploratory Efficacy: Cytokine release plasma level Changed levels from baseline. Three months from randomization
Secondary Exploratory Efficacy: Immune cell graft recruitment plasma level Changed levels from baseline. Three months from randomization
Secondary Exploratory Efficacy: Pharmacokinetics plasma concentration Changed levels from baseline. Three months from randomization
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