Transplantation of Uncontrolled DCD Kidneys REconditioned by a Novel Ex-VIVo Perfusion MEthod

NCT05703633 | Unknown Phase 1 DMC

• 1 other identifier: GOT.2023.1
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

Eight patient will be transplanted with kidneys from donors dying after uncontrolled circulatory arrest (uDCD), with prolonged warm ischemia (up to 4,5 hours), preserved by a new method based on removal of fibrinogen/fibrin in the capillary systems, leading to an effective oxygenation of the tissue using an ex-vivo hospital manufactured perfusion device, minimizing the risk for ischemia-reperfusion injury (I/R-I) after kidney transplantation.Each patient will be studied for three months, with long-term follow-up data collected at 6 and 12 months

Conditions

End-Stage Kidney Disease

Keywords

Kidney Transplantation; uDCD

Outcome Measures

Primary Outcomes (1)

• Safety - Serious Adverse Events

  Occurrence of serious adverse events, Clavien-Dindo IV-V grade complications, including primary none function

  Three months post transplantation

Study Arms (1)

uDCD arm

EXPERIMENTAL

Patients enroled in the study will receive a kidney from a uDCD donor, after the kidney has been subjected to a reconditioning procedure, preventing ischemia/reperfusion-injury, confirming large animal data using the same protocol.

Other: uDCD treatment

Interventions

uDCD treatment OTHER

Thrombolytic treatment/prevention ex-vivo to kidneys procured from patients after circulatory arrest

uDCD arm

Eligibility Criteria

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

You may qualify if:

• Both sexes
• Age 18 - 65
• First-time transplant
• ABO blood-group identical
• Living within 4 hours from transplant site
• Written consent

You may not qualify if:

• Human Leukocyte Antigen (HLA) antibodies and/or preformed donor specific antibodies (DSA)
• Total ischemia time of \> 16 hours
• Multi organ transplant recipients or previously transplanted
• ABO-incompatible or positive complement-dependent crossmatch (CDC X-match)
• Contraindicating medical condition
• Contraindicating malignancy
• Recent drug abuse
• Non-adherent or difficulties understanding the protocol
• Known risk factors for technical surgical complications (i.e. serious arteriosclerosis and or obesity)

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Related Publications (2)

• Olausson M, Antony D, Travnikova G, Johansson M, Nayakawde NB, Banerjee D, Softeland JM, Premaratne GU. Novel Ex-Vivo Thrombolytic Reconditioning of Kidneys Retrieved 4 to 5 Hours After Circulatory Death. Transplantation. 2022 Aug 1;106(8):1577-1588. doi: 10.1097/TP.0000000000004037. Epub 2022 Jul 22.

  PMID: 34974455 BACKGROUND

• Olausson M, Antony D, Johansson M, Travnikova G, Nayakawde NB, Banerjee D, Mackay Softeland J, Ognissanti D, Andresen Bergstrom M, Hammarsten O, Premaratne GU. Long-term Transplant Function After Thrombolytic Treatment Ex Vivo of Donated Kidneys Retrieved 4 to 5 H After Circulatory Death. Transplantation. 2022 Dec 1;106(12):2348-2359. doi: 10.1097/TP.0000000000004235. Epub 2022 Nov 22.

  PMID: 35831928 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niclas Kvarnström, MD, PhD

  Västra Götalandsregionen - SU - Sahlgrenska

  STUDY CHAIR

Central Study Contacts

Michael Olausson, MD, PhD

CONTACT

+46705434360; michael.olausson@transplant.gu.se

Markus Gäbel, MD

CONTACT

+46708643794; markus.gabel@vgregion.se

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single center, open label, proof-of-concept study, Phase 1-2a

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 30, 2023
• Study Start: August 21, 2023
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share