Hypothermic Kidney Machine Perfusion With Omnisol (OMNIPUMP)
A Single-Center, Non-Randomized Safety Study on Hypothermic Machine Perfusion With Omnisol Preservation Solution of Deceased Donor Kidneys Prior to Transplantation
Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors. Preservation of DCD organs using the current clinically applied preservation solutions is associated with up to 73% incidence of delayed graft function, highlighting the need for new preservation solutions designed to improve early graft function.
Omnisol is expected to result in equivalent or improved kidney preservation as compared to currently marketed organ preservation solutions used for HMP.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Hypothermic machine perfusion (HMP) is increasingly used for the preservation of deceased donor kidneys before transplantation. Omnisol was developed as an extracellular-type organ preservation solution for the flushing and HMP of donor kidneys.
Omnisol organ preservation solution was developed to improve kidney transplant outcomes. It is an extracellular-type solution containing the synthetic colloid polyethylene glycol (PEG) and several impermeants for optimal osmotic pressure. It further contains multiple buffering agents for the prevention of intracellular acidosis, antioxidants for the minimization of ROS-induced injury and amino acids and other substrates for supporting the cell metabolism during hypothermic machine perfusion (HMP) as well as the provision of substrates for regeneration of high-energy phosphate compounds during graft reperfusion.
This prospective, single-center, non-randomized clinical investigation is designed primarily to evaluate the safety of Omnisol when used for the wash-out and HMP of kidneys from deceased donors before transplantation. The investigation incorporates a retrospective matched-control design, where each recipient of a kidney preserved with Omnisol will be matched with two recipients previously transplanted at the same center with kidneys preserved by HMP using UW-MPS.
This study employs a back-to-base design, meaning that after arrival at the transplant center according to standard of care, the kidney is flushed with Omnisol and transferred to HMP using Omnisol in the standard of care perfusion machine until implantation.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Inclusion for donor:
- Donor age > 18 years
- Brain Death (DBD) or Circulatory Death (DCD)
- Accepted for transplantation according to local criteria
- For DCD donors: functional warm ischemia time (WIT) ≤ 30 minutes and total WIT ≤ 60 minutes
- Cold ischemia time (CIT) prior to HMP with Omnisol no greater than 14 hours
Inclusion for recipient:
- Male or female, age > 18 years
- Able and willing to provide informed consent and comply with all study requirements (in opinion of investigator or deputy)
- General inclusion criteria applicable to kidney transplantation:
- Listed for renal transplantation due to end stage renal disease on OPO list
- Able and willing to comply with all study requirements (in opinion of investigator or deputy)
- Fit to proceed with kidney
Exclusion Criteria:
Exclusion for donor:
• Donor kidneys accepted as a pair for dual transplant
Exclusion for recipient:
- General exclusion criteria applicable to kidney transplantation
- Breast-feeding or pregnant, as confirmed by pregnancy test or blood test, or plans to become pregnant over the study period
- Participation in an investigational study likely to affect interpretation of the trial data
- Mental disabilities that may affect the understanding of the study requirements including the ability to adhere to medication regime (in opinion of investigator or deputy)
- Undergoing living donor kidney transplantation
- Undergoing dual kidney transplantation
- Undergoing transplantation of other organ(s) in addition to the kidney
- Highly sensitized patients with cPRA > 80% (based on routine HLA antibody assessment)
- Positive donor-specific crossmatch, if performed per institutional standard practice
- Other substantial risk of transplant not proceeding (in opinion of investigator or deputy)
- Other significant disease or disorder which, in the opinion of the Investigator, may: (i) put the participant at risk by participating in the study; (ii) influence the result of the study; (iii) affect the participant's ability to participate in the study
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Donation after brain death (DBD)
Recipients of a kidney from a donor after brain death (DBD). After arrival at the transplant center according to standard of care, kidneys will be flushed with Omnisol and placed on the standard of care HMP machine for perfusion with Omnisol until transplantation. |
Omnisol for HMP of DBD or DCD donors. |
|
Experimentell: Donation after circulatory death (DCD)
Recipients of a kidney from a donor after circulatory death (DCD). After arrival at the transplant center according to standard of care, kidneys will be flushed with Omnisol and placed on the standard of care HMP machine for perfusion with Omnisol until transplantation. |
Omnisol for HMP of DBD or DCD donors. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Delayed Graft Function
Tidsram: 7 days post-transplantation.
|
Incidence of delayed graft function, defined as the requirement for at least one dialysis session within the first 7 days after transplantation, excluding a single dialysis session performed solely for hyperkalemia or volume overload. |
7 days post-transplantation.
|
|
Graft Survival
Tidsram: 30 days post-transplantation.
|
30-day graft survival, censored and uncensored for recipient death. |
30 days post-transplantation.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Graft Survival
Tidsram: 3, 6 and 12 months post-transplantation.
|
Graft survival, censored and uncensored for recipient death. |
3, 6 and 12 months post-transplantation.
|
|
Recipient Survival
Tidsram: 30 days, 3, 6 and 12 months post-transplantation.
|
Rate of recipient survival. |
30 days, 3, 6 and 12 months post-transplantation.
|
|
Kidney Graft Function
Tidsram: 30 days, 3, 6 and 12 months post-transplantation.
|
Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI creatinine equation. |
30 days, 3, 6 and 12 months post-transplantation.
|
|
Primary Non-Function
Tidsram: 30 days, 3, 6 and 12 months post-transplantation.
|
Incidence of irreversible graft failure with no initial evidence of graft function following transplantation. |
30 days, 3, 6 and 12 months post-transplantation.
|
|
Duration of Delayed Graft Function
Tidsram: 30 days post-transplantation.
|
Duration of delayed graft function in participants who require renal replacement therapy after kidney transplantation. |
30 days post-transplantation.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Njurinsufficiens, kronisk
- Patologiska tillstånd, tecken och symtom
- Njurinsufficiens
- Njursvikt, kronisk
Andra studie-ID-nummer
- OMNISOL_HMP_US
Plan för individuella deltagardata (IPD)
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