An investigation into the treatment of the donor kidney to see if this improves the recovery of the kidney after transplantatio

Not Applicable

Completed

• Conditions: Ischaemia-reperfusion injury associated with renal transplantation; Injury, Occupational Diseases, Poisoning; Failure and rejection of other transplanted organs and tissues

• Registration Number: ISRCTN49958194
• Lead Sponsor: King?s College London (UK)

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28587616 2021 results in https://pubmed.ncbi.nlm.nih.gov/33225626/ (added 12/04/2021)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-03
• Study Completion: 2018-05-30
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 560

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Outcome measure as of 21/04/2016:<br> Delayed graft function measured by recording the need for dialysis in the first 7 days following transplantation.<br><br> Previous primary outcome measure:<br> To reduce Delayed Graft Function (DGF) as estimated by the number of patients requiring dialysis in the first week.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary outcome measures as of 21/04/2016:<br> 1. Duration of delayed graft function is measured by recording the need for dialysis at all follow up assessments (up to 12 months)<br> 2. Mean calculated GFR measured using MDRD at 12 months<br> 3. Mean calculated GFR measured using Cockcroft-Gault at 12 months<br> 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<br><br> Previous secondary outcome measures:<br> 1. To include reducing the delay of recovery in those grafts with immediate function independent of dialysis<br> 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<br>