Kidney failure Urological and Genital Diseases
Conditions
Interventions
Mirococept is perfused as a single dose of 60mg, 120mg, 180mg or placebo (vehicle solution), mixed with a cold storage solution to the explanted donor kidney via the renal artery(s) before transplanta
participants 4-6 will receive kidneys treated with 120mg
and participants 7-9 will receive kidneys treated with 180mg. Recruitment within each dosing group will be staggered so that the interval between participants will be a minimum of 48 hours and up to t
Sponsors
Guy's and St Thomas' NHS Foundation Trust
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged = 16 years old and over at the date of consent 2. Registered on the kidney transplant list 3. Recipient of a deceased donor kidney only 4. Able and willing to provide written informed consent 5. Able to comply with study requirements 6. On Dialysis at the date of consent 7. Donor age > 10 years
Exclusion criteria
Exclusion criteria: 1. Evidence of HIV, HCV or current HBV infection at screening 2. Multi-organ transplant or a previous non-renal transplant 3. Planned ABO- or HLA-antibody-incompatible transplant or patients with delisted HLA specificities 4. Recipient of a living-donor kidney 5. Recipient of a DCD kidney Maastricht category 1 or 2 6. Paediatric-en-bloc or an adult double-renal transplant 7. Kidneys undergoing machine perfusion both ex-vivo and Normothermic Regional Perfusion (NRP) 8. Pregnant or lactating patients (females of childbearing potential with a positive serum pregnancy test at screening) 9. Female patients of childbearing potential who are not willing to use a highly effective method of contraception for at least 1-month post-transplantation to prevent pregnancy, or abstain from heterosexual activity 10. Male patients who are not willing to use an effective method of contraception (condoms), at least 1 month post-transplantation, when engaging in sexual activity with a female of childbearing potential 11. Involvement in other interventional trials from the date of consent until completion of visit week 52 12. Known hypersensitivity to Mirococept and/or its excipients 13. Receiving treatment with a systemically administered complement inhibitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delayed graft function (DGF) – the requirement for dialysis during week 1 post-transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional DGF – failure of serum creatinine to decrease by at least 10% daily on 3 consecutive days in week 1 post-transplantation (excludes patients with biopsy-proven rejection or calcineurin inhibitor (CNI) toxicity in week 1 post-transplantation) 2. Number of dialysis sessions during the first 30 days post-transplantation 3. Duration of DGF 4. Mean calculated GFR (CKD-EPI) at 12 months post-transplantation 5. Mean calculated creatinine clearance (Cockcroft-Gault) at 12 months post-transplantation 6. Primary non-function – permanent lack of graft function for 3 months post-transplantation 7. AUC of serum creatinine on days 1-14 post-transplantation 8. Biopsy-proven acute rejection at 6 and 12 months post-transplantation 9. Biopsy-proven calcineurin (CNI) toxicity within 12 months post-transplantation 10. Duration of post-transplantation hospital stay 11. Number and duration of any hospital admissions during the first 12 months post-transplantation 12. 1-year graft survival (censored and uncensored for death with functioning allograft) 13. 1-year patient survival | — |
Countries
England, United Kingdom
Contacts
Public ContactAlima Rahman
Outcome results
None listed