Ischaemia-reperfusion injury associated with renal transplantation Injury, Occupational Diseases, Poisoning Failure and rejection of other transplanted organs and tissues
Conditions
Interventions
Interventions as of 21/04/2016:
Participants are randomly allocated to Mirococept (Active IMP) or Soltran (Placebo). Randomisation will be carried out in blocks
stratified by centre, type of donor (DCD/Donation after Brain Death (DBD)) and machine pump use. Immunosuppression therapy, antibiotic and antiviral prophylaxis will be administered as per local centr
10mg
15mg
20mg and 25mg. The adaptive allocation will be based on a t-test (like) statistic that compares the difference between responses (accumulated) at the current dose, with the mean response at placebo pl
Sponsors
King?s College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 21/04/2016: 1. Aged 16 years or older 2. Registered on the kidney transplant list 3. Willing to participate in the study and provide written informed consent 4. Must have the ability to comply with the study requirements 5. Patient is on dialysis 6. Receiving kidney from a donor over 10 years of age Original inclusion criteria: 1. Patient must be 16 years of age or older 2. Patient must be willing to participate in the study & provide written informed consent 3. Patient must have the ability to comply with the study requirements 4. Donor must be older than 10 years of age
Exclusion criteria
Exclusion criteria: Exclusion criteria as of 21/04/2016: 1. Patient is recipient of a living-donor kidney 2. Patient is a recipient of a DCD kidney Maastricht category 1 or 2 3. Patient has evidence of current infection with HIV, HBV or HCV 4. Patient is recipient of a paediatric en bloc or a adult double renal transplant 5. Any recipient of a multi-organ transplant or a previous recipient of a non-renal solid organ transplant 6. Females who are pregnant or lactating 7. Male and Female patients not willing to use contraception for at least one month post-transplant 8. Any planned ABO blood group or HLA antibody incompatible transplant 9. Patient is involved in other experimental drug trials Original exclusion criteria: 1. Patient is recipient of a living-donor kidney 2. Patient is not yet on dialysis 3. Patient is a recipient of a Donation after Cardiac Death (DCD) kidney Maastricht category 1 or 2 4. Patient has evidence of current or previous infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) 5. Patient is recipient of an en bloc double renal transplant 6. The donor kidney has more than 2 renal arteries, unless the artery is small enough to be ligated and not perfused. 7. Any ABO or HLA incompatible transplant 8. Patients receiving donor organs with a cold ischaemic time >30 hours 9. Any recipient of a multi-organ transplant or a previous recipient of a non-renal solid organ transplant 10. Females who are pregnant or lactating 11. Patients not willing to use contraception for at least one month post transplant 12. Patients with a history of malignancy within the last 5 years, except adequately treated squamous or basal cell carcinomas of the skin or cervical intraepithelial neoplasia 13. Patients involved in other experimental drug trials 14. Patients who might be expected to have an allergic response to the molecule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome measure as of 21/04/2016: Delayed graft function measured by recording the need for dialysis in the first 7 days following transplantation. Previous primary outcome measure: To reduce Delayed Graft Function (DGF) as estimated by the number of patients requiring dialysis in the first week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 21/04/2016: 1. Duration of delayed graft function is measured by recording the need for dialysis at all follow up assessments (up to 12 months) 2. Mean calculated GFR measured using MDRD at 12 months 3. Mean calculated GFR measured using Cockcroft-Gault at 12 months 4. Functional delayed graft function is measured by the absence of decrease in serum creatinine of at least 10% per day for at least 3 consecutive days in first week post-transplant Previous secondary outcome measures: 1. To include reducing the delay of recovery in those grafts with immediate function independent of dialysis 2. To determine if treatment influences renal function/histology at 12 months (a surrogate of long term graft outcome) and acute rejection episodes during this time | — |
Countries
United Kingdom
Contacts
Public ContactLaura Nicols
Outcome results
None listed