Status:
COMPLETED
FIH Phase I/IIa Trial Evaluating Safety of TUM012 to Minimize Ischemic Reperfusion Injury in Kidney Transplantation
Lead Sponsor:
iCoat Medical AB
Collaborating Sponsors:
CTC Clinical Trial Consultants AB
Region Skane
Conditions:
Ischemia-reperfusion Injury
Kidney Transplant; Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 redu...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05246618
Start Date
March 31 2022
End Date
May 14 2024
Last Update
June 4 2024
Active Locations (1)
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1
Skane University Hospital
Malmo, Sweden, SE-205 02