Kidney Protective Jacket

NCT07348458 | Recruiting DMC

• 1 other identifier: CI-TPL-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a safety study designed to investigate the safety of utilizing the Kidney Protective Jacket (KPJ)™ during kidney transplantation. In general, we aim to use the device in all possible recipients, aiming to demonstrate its safety in the variable circumstances that may arise during kidney transplantation, e.g. single or multiple renal vessels, different-sized kidneys, and variable recipient size and weight.

Conditions

Kidney Transplant

Keywords

Kidney transplant; Renal transplant; Second warm ischaemic time; Ischaemia-reperfusion injury; Kidney Protective Jacket; Graft cooling

Outcome Measures

Primary Outcomes (1)

• Safety of the Kidney Protective Jacket

  The primary objective is to assess the safety of use of KPJ™ (per its intended use) during kidney transplantation. Specifically, we are assessing the proportion of participants sustaining Serious Adverse Effects directly attributable to KPJ use (i.e., Serious Adverse Device Events \[SADE\]) in the time period of 30 days post transplantation. We also want to examine the safety in variable circumstances, e.g. single and multiple renal vessels, different sized kidneys, variable recipient size and weights.

  Until 20 participants are recruited, baseline participant characteristics collected pre-operatively, intra-operative times noted, and incidence of serious adverse events at 30 days post procedure.

Secondary Outcomes (7)

• Device related events

  When 20 participants have been recruited and 30 days post transplantation procedure.

• Temperature change during SWIT (°C)

  When 20 participants have been recruited and 30 days post transplantation procedure.

• Surgery time (minutes)

  When 20 participants have been recruited and 30 days post transplantation procedure.

• Delayed graft function (%)

  When 20 participants have been recruited and 30 days post transplantation procedure.

• Serum creatinine (μmol/L)

  When 20 participants have been recruited and 30 days post transplantation procedure.

Study Arms (1)

Kidney Protective Jacket

EXPERIMENTAL

Application of the KPJ to the renal transplant.

Device: Kidney Protective Jacket

Interventions

Kidney Protective Jacket DEVICE

The KPJ™ is a novel thermal insulating protective jacket specifically designed to be applied to the kidney during transplant anastomoses, or the SWIT interval. It is applied prior to removing the kidney from cold storage, and remains on for the duration of anastomoses, after which it can be easily removed. The Kidney Protective Jacket (KPJ) was designed and developed in accordance with ISO 13485 and 21 CFR 820 design control requirements. Throughout the development process, relevant standards were applied, including those related to risk management (ISO 14971), usability engineering (IEC 62366), biocompatibility of materials (ISO 10993 series), and sterilisation validation (ISO 11137). Manufacturing is carried out by an ISO 13485-certified contract manufacturer, with processes including injection moulding of medical-grade silicone, assembly of the sterile barrier system (comprising a medical-grade plastic tray and Tyvek® seal), and final device packaging. Sterilisation is performed us

Kidney Protective Jacket

Eligibility Criteria

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

You may qualify if:

• All deceased and living donor kidneys that are deemed suitable for transplantation
• All suitable recipients who are 18 years or greater, and undergoing their first or second kidney transplant
• All recipients must be able to provide full informed consent

You may not qualify if:

• Paediatric donor kidneys (kidneys from donors \< 16 years in age)
• Patients with a known allergy or hypersensitivity to silicone

Sponsors & Collaborators

• iiShield: lead
• Western Sydney Local Health District: collaborator

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Amy Hort, MBBS (HONS), MS, FRACS

CONTACT

+61432782850; amy.hort@health.nsw.gov.au

Phoebe Lau, BME (HONS), ME

CONTACT

+61 421 931 429; phoebe@iishield.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participant and outcomes assessor will be blinded
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)