Health Trials

NRP + ex Situ HMPO2 vs NRP Alone in DCD Kidney Transplantation

ConditionsKidney TransplantDCD Kidney
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska University Hospital

About this trial

The goal of this clinical trial is to learn if the combination of Normothermic Regional Perfusion (NRP) at the time of organ procurement with ex situ Hypothermic Oxygenated Perfusion (HMPO2) of kidneys recovered from donors after circulatory death (DCD) is superior to NRP alone. The researchers will learn if the combined use of these technologies provides a benefit in terms of kidney transplant outcomes. The researchers will also learn about the patient quality of life after these transplants and if the use of these technologies is cost efficient. The main questions it aims to answer are:

* Does NRP +HMPO2 provides a better DCD kidney function at 1 year post-transplant compared to NRP alone. * Are the postoperative complications and outcomes different between the two groups? * Is the quality of life of recipients different between the two groups? * Is the use of NRP +HMPO2 a cost effective strategy? Researchers will compare NRP and HMPO2 with NRP alone to see if the combined use of the technologies provides better transplant outcomes.

Participants will:

* Receive a kidney treated with one of the two strategies. * Visit the clinic as per usual clinical practice for checkups and tests * Report on their quality of life pre and post transplant * Undergo a kidney biopsy at one year to forecast long term transplant function

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All DCD donors in Sweden with consent for organ donation and where organ recovery is undertaken with NRP.

Kidney deemed transplantable by donor surgeon and responsible transplant surgeon (not discarded before or during procurement)

All adult patients (>18 yrs old) eligible for renal transplantation during study duration.

Recipient consented for surgery, matched to a DCD kidney.

Disqualifiers

Paediatric patients (<18 yrs old).

Participation in other clinical drug or medical devices trials.

Patient subject to combined transplant of kidney + other organ.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ex situ hypothermic oxygenated machine preservation

    Device

    Ex situ preservation of NRP DCD kidneys with hypothermic oxygenated machine perfusion

Treatment groups

214 Participants
are divided into 2 treatment groups
Group A: NRP + HMPO2Experimental treatment 1 intervention
Group B: NRP aloneNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Renal function after transplantation

Renal function estimated by the glomerular filtration rate at 1 year after transplantation as determined by the Lund Malmö revised formula for eGFR calculated based on creatinine value

Time frame
One year after transplantation

Secondary outcomes

1

1. the iBox score at one year

iBOX scoring system is an innovative composite endpoint that has been validated by EMEA and FDA as the first surrogate end point for clinical studies. iBox is a risk prediction score that utilises multiple clinical and pathological relevant features (estimated glomerular filtration rate (eGFR), proteinuria, anti-human leukocyte antigen donor-specific antibody, and kidney graft biopsy histopathology) at one-year post-transplant to predict the likelihood of the transplanted kidney to fail over fixed intervals (3, 5, and 7 years). The output is presented as a continuous mathematical percentage and the score is interpreted as the absolute statistical risk of losing the kidney graft.

Time frame
One year after transplantation
2

Graft (uncensored and censored for recipient death) survival

Survival rate of kidney transplant

Time frame
One year after transplant
3

Patient survival

Proportion of patient survivint

Time frame
One year after transplantation
4

Delayed graft function

Need for dialysis for all causes within the first 7 days after kidney transplantation.

Time frame
7 days after transplantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska University Hospital

Lead sponsor

Uppsala University Hospital

Collaborator

Skane University Hospital

Collaborator

Sahlgrenska University Hospital

Collaborator

Karolinska University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: