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

NCT05246618 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-06-04

No results posted yet for this study

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

Interventions

DRUG

TUM012

Ex-vivo infusion

DRUG

Placebo

Ex-vivo infusion

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Region Skane

    collaborator OTHER

  • iCoat Medical AB

    lead INDUSTRY

Principal Investigators

  • Ingegerd Dalfelt · iCoat Medical AB

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2023-07-31
Completion
2024-05-14

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05246618 on ClinicalTrials.gov