FIH Phase I/IIa Trial Evaluating Safety of TUM012 to Minimize Ischemic Reperfusion Injury in Kidney Transplantation
NCT ID: NCT05246618
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2022-03-31
2024-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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TUM012
Ex-vivo infusion
TUM012
Ex-vivo infusion
Placebo
Ex-vivo infusion
Placebo
Ex-vivo infusion
Interventions
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TUM012
Ex-vivo infusion
Placebo
Ex-vivo infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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CTC Clinical Trial Consultants AB
INDUSTRY
Region Skane
OTHER
iCoat Medical AB
INDUSTRY
Responsible Party
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Principal Investigators
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Ingegerd Dalfelt
Role: STUDY_DIRECTOR
iCoat Medical AB
Locations
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Skane University Hospital
Malmo, , Sweden
Countries
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Other Identifiers
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ATMIRe
Identifier Type: -
Identifier Source: org_study_id
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