FIH Phase I/IIa Trial Evaluating Safety of TUM012 to Minimize Ischemic Reperfusion Injury in Kidney Transplantation

NCT05246618 | Completed Phase 1 DMC

• 1 other identifier: ATMIRe
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 reduce ischemia-reperfusion injury in de novo kidney transplant recipients.

Conditions

Ischemia-reperfusion Injury; Kidney Transplant; Complications

Keywords

Ex-vivo kidney allograft treatment; Transplant outcome

Outcome Measures

Primary Outcomes (7)

• Adverse Events

  Number of patients with confirmed IMP-related events

  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.

  Three months from randomization

• 12-lead Electro-Cardiogram (Standard of Care Safety)

  Assessment: "normal", "abnormal, not clinically significant", or "abnormal, clinically significant"

  Three months from randomization

• Systolic/diastolic BP (Standard of Care Safety)

  Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"

  Three months from randomization

• Pulse Rate (Standard of Care Safety)

  Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"

  Three months from randomization

• Peripheral blood oxygenation (Standard of Care Safety)

  Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"

  Three months from randomization

• Body temperature (Standard of Care Safety)

  Assessment: "normal", "abnormal, not clinically significant", or "abnormal clinically significant"

  Three months from randomization

Secondary Outcomes (7)

• Exploratory histological evaluation of kidney graft

  Three months from randomization

• Exploratory kidney graft function

  Three months from randomization

• Exploratory Efficacy: Proteomics

  Three months from randomization

• Exploratory Efficacy: Markers of IR injury and thromboinflammation plasma level

  Three months from randomization

• Exploratory Efficacy: Cytokine release plasma level

  Three months from randomization

Other Outcomes (3)

• Patient survival

  One year from randomization

• Incidence of graft rejection

  One year from randomization

• Graft survival

  One year from randomization

Study Arms (2)

TUM012

EXPERIMENTAL

Ex-vivo infusion

Drug: TUM012

Placebo

PLACEBO COMPARATOR

Ex-vivo infusion

Drug: Placebo

Interventions

TUM012 DRUG

Ex-vivo infusion

Also known as: Ex-vivo infusion

TUM012

Placebo DRUG

Ex-vivo infusion

Also known as: Ex-vivo infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• iCoat Medical AB: lead
• CTC Clinical Trial Consultants AB: collaborator
• Region Skane: collaborator

Study Sites (1)

Skane University Hospital

Malmo, SE-205 02, Sweden

Location

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ingegerd Dalfelt

  iCoat Medical AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: February 18, 2022
• Study Start: March 31, 2022
• Primary Completion: July 31, 2023
• Study Completion: May 14, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After End of Trial
• Access Criteria: 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, as well as on the company website.

Locations

SE (1)