|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT01756508 |
|
Date of registration:
|
20/12/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury
|
|
Scientific title:
|
Study of Eculizumab for Prevention and Treatment Reperfusion Injury in Kidney Transplantation. |
|
Date of first enrolment:
|
September 1, 2012 |
|
Target sample size:
|
57 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01756508 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Russian Federation
| | | | | | | |
|
Contacts
|
|
Name:
|
Michael M Kaabak, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Russian Scientific Center of Surgery |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. age 1-80
2. weight - >6 kg
3. male or female
4. recipient of first kidney graft either from standard criteria deceased or live donor
5. end stage renal disease or congenital nephrotic syndrome -
Exclusion Criteria:
1. Blood group (ABO) incompatible transplantation
2. presence of donor-specific anti-human leukocyte antigen (HLA) antibodies
3. multiorgan transplantation
4. previous transplant
5. patients infected with HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)
6. patients with haemolytic-uraemic syndrome (HUS) -
Age minimum:
12 Months
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Graft Reperfusion Injury
|
|
End-Stage Renal Disease
|
|
Kidney Failure
|
|
Intervention(s)
|
|
Drug: eculizumab
|
|
Primary Outcome(s)
|
|
speed of the graft warming
[Time Frame: at the time of engraftment]
|
|
Secondary Outcome(s)
|
|
primary graft function
[Time Frame: first week after Tx]
|
|
graft morphology changes
[Time Frame: one year after transplantation]
|
|
One-year graft and patient survival, as well as rejection and infection rates will be calculated
[Time Frame: one year after Tx]
|
|
Secondary ID(s)
|
|
Eculizumab for reperfusion
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|