Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients (CIHMP)

Xi'an Jiaotong University

Status: Unknown

Conditions: Delayed Function of Renal Transplant

Treatments: Device: Kidney Transporter machines; Device: cold storage

Study type: Interventional

Funder types: Other

Identifiers

NCT02621281

LPT-G-1501

Details and patient eligibility

About

This is a multi-centers prospective, randomized, controlled trial. This trial will investigate the clinical outcome of kidney transplant recipients whose kidneys are under two different forms of organ preservation--hypothermic machine perfusion vs. static cold storage. Factors during the machine perfusion, such as the pressure, flow rate, and resistance index will also be investigated.

Full description

In this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. All 400 patients will be followed for 1 year. The primary endpoint is delayed graft function (requiring dialysis in the first week after transplantation) and duration of delayed graft function. The second endpoints: GFR at week 1, month3, month6 and month 12 post-transplant.

Enrollment: 400 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Donor

  1. Comply with the national DCD（donor after citizen death) guideline
  2. No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior
  3. No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered
  4. No active, untreated systemic bacterial, viral or fungal infection;
  5. Patients definitely identified
  6. Mechanical perfusion RI (resistance index ) [0.18, 0.50]

Recipient:

1. Age> = 16 years old, male or female
2. BMI<28
3. First Renal transplantation
4. Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
5. Before the clinical trial, Patient sign informed consent voluntarily

Exclusion criteria

• Donor

  1. Older than 50 years old
  2. Serum HBV (hepatitis B virus), HCV (hepatitis C virus), HIV positive
  3. Donor kidney cold storage time over 30 hours
  4. Warm ischemia time over 20 minutes
  5. Other reagents are added perfusion for regulation of donor renal function

Recipient:

1. Double organ or multi-organ transplant
2. Blood type-incompatible
3. Patients with other malignant diseases

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

cold storage

Active Comparator group

Description:

In this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration.

Treatment:

Device: cold storage

Kidney Transporter machines

Active Comparator group

Description:

In this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration.

Treatment:

Device: Kidney Transporter machines