A multicentre randomised controlled trial to compare the efficacy of ex-vivo oxygenated hypothermic machine perfusion with non-oxygenated hypothermic machine perfusion of kidneys from donors older than 50 years of age and donated after circulatory death.

A multicentre randomised controlled trial to compare the efficacy of ex-vivo oxygenated hypothermic machine perfusion with non-oxygenated hypothermic machine perfusion of kidneys from donors older than 50 years of age and donated after circulatory death. - COPE-COMPARE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44723

Enrollment

Registered

2014-11-13

Start date

2015-07-20

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endstage renal failure

Interventions

Eligible kidneys will be randomised in equal proportions between control and intervention. Group 1 - control group: the kidney will be placed on the Kidney Assist HMP device and perfused with Belzer

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For the donor and the donor kidney: - Maastricht category III DCD donors (donors who died after circulatory arrest in a controlled setting) - Aged 50 years or older;For the recipient: - At least 18 years of age - Listed for renal trasplantation due to end stage renal disease on the ET or NHSBT renal waiting list within one of the participating centres - Willingness to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations

Exclusion criteria

Exclusion criteria: For the donor and the donor kidney: - Kidney deemed untransplantable by the retrieval surgeon. The contralateral kidney will also not be randomised as the trial is designed as a paired trial;For the recipient: - Scheduled to undergo multi-organ transplantation - Planned dual kidney transplantation

Design outcomes

Primary

Measure	Time frame
Estimated Glomerular filtration rate at 1 year after transplantation (time window of 30 days) as determined by the EPI-CKD equation.	—

Secondary

Measure	Time frame
7 day, 3, 6, and 12 month graft and patient survival. Delayed graft function (DGF), defined as the need for dialysis in the first 7 days after transplantation and preceding the return of kidney function Functional DGF, defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first 7 days after transplantation. eGFR defined by the 4-variable MDRD equation at 3, 6, and 12 months after transplantation. eGFR defined by the EPI-CKD equation at 3 and 6 months after transplantation. Measured GFR defined by creatinine clearance in 24 hours urine collection. Primary non function (PNF), defined as the continued need for dialysis at 3 months after transplantation. Comparison of biopsy proven acute rejection between the 2 groups. Adverse events, transplantation and organ discard rates. Quality of life measures (EQ-5D-5L) at 3, and 12 months. Logistical and healthcare costs and resource use.	—

Measure

Time frame

7 day, 3, 6, and 12 month graft and patient survival. Delayed graft function (DGF), defined as the need for dialysis in the first 7 days after transplantation and preceding the return of kidney function Functional DGF, defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first 7 days after transplantation. eGFR defined by the 4-variable MDRD equation at 3, 6, and 12 months after transplantation. eGFR defined by the EPI-CKD equation at 3 and 6 months after transplantation. Measured GFR defined by creatinine clearance in 24 hours urine collection. Primary non function (PNF), defined as the continued need for dialysis at 3 months after transplantation. Comparison of biopsy proven acute rejection between the 2 groups. Adverse events, transplantation and organ discard rates. Quality of life measures (EQ-5D-5L) at 3, and 12 months. Logistical and healthcare costs and resource use.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)