Remote Post-Conditioning (RPC) in renal transplantation | Not Recruiting
Remote Post-Conditioning (RPC) in renal transplantation
RPC
Trial Source

Health Conditions
  • Kidney injury after transplantation
Not Recruiting
Recruitment Status
ISRCTN66437627
Primary Trial ID Number
Summary
Remote Post-Conditioning (RPC) can improve post transplant function and graft survival in renal transplant recipients
Primary Outcome Measures
  • Live donor:
  • 1. Slow graft function measured by creatinine fall in the first 24 hours and Area under the curve (AUC) serum creatinine over the first 7 days post transplant
  • 2. Graft function rates: incidences of delayed graft function and primary non-function
  • 3. Glomerular filtration rate (eGFR) and serum creatinine levels: 1 and 3 months
  • 4. Graft survival
  • 5. Patient survival
  • 6. Episodes of rejection within the first 3 months (cell and antibody mediated)
  • Deceased donor:
  • 1. Slow graft function measured by creatinine fall in the first 24 hours and Area under the curve (AUC) serum creatinine over the first 7 days post transplant
  • 2. Graft function; incidences of delayed graft function and primary non-function
  • 3. Glomerular filtration rate (eGFR) and serum creatinine levels: 1 and 3 months
  • 4. Graft survival
  • 5. Patient survival
  • 6. Episodes of rejection within the first 3 months (cell and antibody mediated)
Secondary Outcome Measures
  • Live and deceased donor:
  • In addition, we wish to further understand the mechanisms by which remote postconditioning (RPC) conveys its protective actions.
  • 1. The renal blood flow into the kidney in the immediate post transplant phase will be measured using a Doppler flow probe. The renal vascular resistance will be calculated from the kidney weight and renal arterial blood flow
  • 2. Mediators of RPC: Nitric oxide levels and adenosine levels determined by ELISA using plasma samples taken from the renal vein 30 minutes after reperfusion and from peripheral venous samples (see blood sample protocol)
  • 3. Markers of ischaemic injury: Neutrophil gelatinase-associated lipocalin (NGAL)- small protein that is increased with ischaemic injury, KIM-1, Oxidative damage (protein carbonyl, Lipid peroxidation, DNA damage), Inflammation; levels of cytokines (IL-1, IL-©¬, IL-2, IL-6, IL-8, IL-10, TNF-¥á), determined using plasma and urine samples
  • 4. Measure the level of repair: Determination of up and down regulated genes using gene array analysis in renal biopsies. The presence of genes such as those involved in apoptosis (anti-apoptotic Bcl-2), Protection [Hemeoxygenase-1 (HO-1) and Heat shock protein (HSP)] and fibrosis will be validated by RT-PCR.
  • 5. Histological changes: Biopsies will be stained with H&E for histological scoring, immunohistochemistry techniques to determine injury and Sirius red (an extracellular matrix stain) to measure interstitial fibrosis
Research Question
  • Remote Post-Conditioning (RPC) can improve post transplant function and graft survival in renal transplant recipients
Design Type
Sorry, this information is not available
Ethics Approval
National Research Ethics Service East Midlands, Leicester, 6 May 2010, ref: 11/EM/0130
Publications
Sorry, this information is not available
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
80
Participant Inclusion Criteria
  • 1. Age greater than or equal to 18 years
  • 2. Patients receiving a primary or secondary renal allograft from a live or donation after Brain Stem Death (DBD donor)
  • 3. Patients with second transplants must have maintained their primary graft for at least six months after transplantation (with the exception of graft failure due to technical reasons)
  • 4. Signed written informed consent
Participant Exclusion Criteria
  • 1. Blood type ABO incompatible live donor transplants
  • 2. Donation after cardiac death donors
  • 3. Patients with severe peripheral vascular disease
  • 4. Patients on ATP-sensitive potassium channel opening or blocking drugs
Interventions
Patients will be randomised to either receive RPC during transplantation or the standard transplant with sham procedure
Design Details
Sorry, this information is not available
Study Design
Doubled blinded randomised controlled trial
Results Reporting
Sorry, this information is not available
Acronym
RPC
Scientific Title
A doubled blinded randomised controlled trial of Remote Post-Conditioning in renal transplantation
Secondary Trial Identifying Number
UHL 11035
Website
Sorry, this information is not available
Study Funded By
University Hospitals of Leicester NHS Trust (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
University of Leicester (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

21 Aug 2011

Recruitment End Date

21 Aug 2014

Trial End Date

21 Aug 2014

Date added to Registry

19 Sep 2011

Last Updated

17 Aug 2012