Normothermic Machine Perfusion (NMP) Versus Hypothermic Machine Perfusion (HMP) in Human Kidney Transplantation

NCT05743751 | Unknown DMC FDA Device

• 1 other identifier: 2022-NHLHCRF-LX-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the rising incidence of renal failure and the improvement of organ transplantation technology, the shortage of donor organs has become one of the main problems limiting the development of kidney transplantation. Marginal donor is one of the important ways to extend the donor pool. Normothermic mechanical perfusion (NMP) is a new generation of organ preservation technology, which can maintain the blood supply and at the same time evaluate the marginal kidney function during the organ preservation. However, the clinical effect has not been proved. Hypothermic Machine Perfusion (HMP) is the mainstream organ perfusion technology. This study aims to compare the effectiveness of NMP with the HMP.

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; Normothermic Machine Perfusion; Hypothermic Machine Perfusion

Outcome Measures

Primary Outcomes (1)

• Rate of delayed renal function (DGF)

  At least one dialysis is required within one week after kidney transplantation

  1 week after surgery

Secondary Outcomes (5)

• Estimated glomerular filtration rate

  3, 6, 12 months after surgery

• Rate of primary non-function (PNF)

  1 months after surgery

• Graft survival and recipient survival

  1 year follow-up

• Complications

  within 90 days after operation

• Patient death

  1 year follow-up

Other Outcomes (1)

• Hospitalization expenses

  3, 6, 12 months after surgery

Study Arms (2)

Hypothermic machine perfusion

ACTIVE COMPARATOR

After organ acquisition, the donor kidney was trimmed, and then the donor kidney was connected to the cryoperfusion machine (lifeport, which has been used in routine clinical practice in our hospital) for continuous low temperature mechanical perfusion (\<8 ℃). The perfusion solution was extracted for proteomic study at 10 min after perfusion and at the end of perfusion.

Device: Hypothermic machine perfusion

Normothermic machine perfusion

EXPERIMENTAL

After conventional UW perfusion is obtained, the marginal donor kidney is immediately perfused without ischemia at normal temperature. The perfusion time is at least 4 hours (so as to repair the marginal donor kidney). The perfusion solution is as above, and the perfusion solution is loaded into the device authorized in Europe (XVIVO - KidneyAssist ®）， Connect the transplanted renal artery with the device. Take 5ml perfusion solution in advance before perfusion, 5ml perfusion solution every 30min after perfusion, take perfusion solution at the end of perfusion (blood gas analysis for each perfusion solution, and finally perfusion solution for culture), and measure urine volume every hour. After perfusion, the transplanted kidney was disconnected from the perfusion device, and the donor kidney was perfused again with 2L HTK solution, followed by routine transplantation.

Device: Normothermic machine perfusion

Interventions

Normothermic machine perfusion DEVICE

XVIVO (perfusion company, Gothenburg, Sweden), functions to be included in perfusion equipment, cardiopulmonary bypass machine and neonatal cardiopulmonary bypass machine, including polyethylene pipeline, heating equipment (perfusion temperature 37 ℃), venous pool (venous pressure is 0 mmHg, adjust the height of perfusion pool), centrifugal pump (arterial pressure is set at initial 75 mmHg, maintain 65 mmHg). The perfusion solution contains 215ml of dextran/albumin solution and 400ml of hematocrit, 2ml of 10% calcium gluconate, 1300u/L heparin and 400mg of cefazolin sodium. The oxygen/carbon dioxide ratio is (95%/5%, 2L/min) for continuous perfusion, and pO2 is maintained at 650mmHg during perfusion. During perfusion, continue to use verapamil, amino acid, glucose and insulin. Lactic acid Ringer solution (10ml/h) was used to supplement the lost circulation volume due to urine production during perfusion.

Normothermic machine perfusion

Hypothermic machine perfusion DEVICE

LifePort Kidney Transporter is designed to integrate with the clinical environment by using readily available supplies, requiring minimal user intervention, and by being easy to use. LifePort Kidney Transporter is a portable, isolated kidney perfusion and transport system, designed to support a donated kidney and to maintain the organ in a near-normal physiologic state under hypothermic aseptic conditions. An insulated plastic housing encloses the kidney and perfusate within a LifePort Kidney Transporter Disposable Perfusion Circuit. LifePort Kidney Transporter components include an Ice Container, Pump Deck, Control Panel, Outer Display, Bubble Detectors, External Connections Panel, sensors, and four lithium-ion batteries. Two handles make the unit easy to lift and carry

Hypothermic machine perfusion

Eligibility Criteria

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

You may qualify if:

• Age 18-60 years old, gender unlimited
• Volunteer to participate in this clinical trial and sign the informed consent form
• Suffering from end-stage renal disease
• Planned kidney transplantation
• The expanded standard donors (ECD) were obtained
• The expanded standard kidney donor is defined as: aged cadaver donors over 60 years old or two or three of the following conditions between 50 and 60 years old: death due to cerebrovascular disease; Hypertension; The blood creatinine level before donation was greater than 133umol/L.

You may not qualify if:

• Active infection
• Living donor kidney recipient
• Acute rejection
• Second kidney transplantation
• Combined transplantation (combined liver and kidney, combined pancreas and kidney)
• Patients who take other clinical trial drugs or participate in other clinical studies
• Unable to continue the research
• Patients who are judged by the researcher to be unsuitable for this clinical trial

Sponsors & Collaborators

• Zhang Tianyu: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (4)

• Hamar M, Urbanellis P, Kaths MJ, Kollmann D, Linares I, Ganesh S, Wiebe A, Cen JY, Yip P, John R, Konvalinka A, Mucsi I, Ghanekar A, Bagli D, Grant D, Robinson LA, Selzner M. Normothermic Ex Vivo Kidney Perfusion Reduces Warm Ischemic Injury of Porcine Kidney Grafts Retrieved After Circulatory Death. Transplantation. 2018 Aug;102(8):1262-1270. doi: 10.1097/TP.0000000000002245.

  PMID: 29683999 BACKGROUND

• Nicholson ML, Hosgood SA. Renal transplantation after ex vivo normothermic perfusion: the first clinical study. Am J Transplant. 2013 May;13(5):1246-52. doi: 10.1111/ajt.12179. Epub 2013 Feb 22.

  PMID: 23433047 BACKGROUND

• Mazilescu LI, Urbanellis P, Kim SJ, Goto T, Noguchi Y, Konvalinka A, Reichman TW, Sayed BA, Mucsi I, Lee JY, Robinson LA, Ghanekar A, Selzner M. Normothermic Ex Vivo Kidney Perfusion for Human Kidney Transplantation: First North American Results. Transplantation. 2022 Sep 1;106(9):1852-1859. doi: 10.1097/TP.0000000000004098. Epub 2022 Mar 1.

  PMID: 35238854 BACKGROUND

• Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.

  PMID: 38979743 DERIVED

Study Officials

• Zhou Xiaofeng, MD

  China-Japan Friendship Hospital

  STUDY CHAIR

Central Study Contacts

Zhou Xiaofeng, MD

CONTACT

17310336871; 13911250201@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participant and care provider were blinded to the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 24, 2023
• Study Start: March 3, 2023
• Primary Completion: December 3, 2024
• Study Completion: September 3, 2025
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: one year after research end
• Access Criteria: share the data

Locations

CN (1)