Last updated: 02/06/2024 15:30:19
Short term outcomes of Donation after Circulatory Death (DCD) renal transplantation in the United Kingdom
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Short term outcomes of Donation after Circulatory Death (DCD) renal transplantation in the United Kingdom
Trial description: This is a retrospective, observational medical chart review study of subjects who are first or second time recipients of single kidney-only transplants from 2010 through 2015. The objective is to obtain historical standard of care data on functional outcomes (frequency of delayed graft function, serial creatinine values, frequency of dialysis episodes, graft survival and mortality) within the first year post-transplant. Data will be provided from the UK Transplant Registry held by NHS Blood and Transplant (NHSBT) and medical records from transplant centres in the UK.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Frequency of delayed graft function in first 7 days post-transplantation
Timeframe: From transplant to Day 7 (assessed for approximately 7 days)
Number of dialysis events in first 30 days after transplantation
Timeframe: From transplant to Day 30 (assessed for approximately 30 days)
Frequency of rejection episodes in one year of follow-up
Timeframe: From transplant to 12 month (assessed for approximately 1 year)
One year graft survival
Timeframe: From transplant to 12 month (assessed for approximately 1 year)
All-cause mortality in one year
Timeframe: From transplant to 12 month (assessed for approximately 1 year)
Longitudinal serum creatinine in one year post transplantation
Timeframe: From transplant to 12 month (assessed for approximately 1 year)
Longitudinal eGFR levels in one year post transplantation
Timeframe: From transplant to 12 month (assessed for approximately 1 year)
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
0
Primary completion date:
2018-07-12
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Heide Stirnadel-Farrant, George Mu, Selin Cooper-Blenkinsop, Rosemary O Schroyer, Kevin S Thorneloe, Ewen M Harrison, Susan MS Andrews.Predictive value of delayed graft function definitions following donation after circulatory death renal transplantation in the United Kingdom.Transpl Res Risk Manag.2022;2022(14):21-33
DOI: https://doi.org/10.2147/TRRM.S320221
Medical condition
Kidney Transplantation (status post)
Product
GSK1070806
Collaborators
National Health Service Blood and Transplant (NHS BT)
Study date(s)
April 2017 to December 2018
Type
Observational
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Subjects recipient of DCD Kidney
- Subjects recipient of first or second time and single kidney-only transplant
- No exclusion criteria
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects recipient of DCD Kidney
- Subjects recipient of first or second time and single kidney-only transplant
- Subjects who received kidney transplant between 2010 and mid-2015
- Age 18 years and older
Exclusion criteria:
- No exclusion criteria
Trial location(s)
Location
GSK Investigational Site
Newcastle upon Tyne., United Kingdom, NE7 7DN
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2018-07-12
Actual study completion date
2018-07-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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