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Clinical Trials/NCT04855123
NCT04855123
Terminated
Not Applicable

Evaluation of the Degradation of Renal Function Post Nephrectomy According to Retinal Vascularisation Parameters "NEPHRIN"

Centre Hospitalier Universitaire Dijon2 sites in 1 country30 target enrollmentMarch 18, 2021

Overview

Phase
Not Applicable
Intervention
retinal imaging
Conditions
Nephrostomy
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
30
Locations
2
Primary Endpoint
Decline in renal function one year after nephrectomy
Status
Terminated
Last Updated
5 days ago

Overview

Brief Summary

Chronic kidney failure in the single remaining kidney is one of the dreaded complications of nephrectomy in patients operated on for cancer-related reasons (1). Indeed, chronic kidney disease (CKD) is associated with major cardiovascular morbidity and mortality (2).

To date, there are few non-invasive methods available to predict the onset and progression of CKD in patients for whom nephrectomy is indicated. Preoperative creatinine and glomerular filtration rate are poor predictors of the subsequent risk of single kidney failure (1). Early predictive markers could help anticipate the management of CKD in patients for whom progression to end-stage renal disease is predictable. Furthermore, such markers could be used as a decision-making aid to specify the type of nephrectomy to be preferred (total versus partial nephrectomy).

The state of microcirculation, particularly retinal, is correlated with the progression of certain conditions such as diabetic nephropathy (3-5). A new technique for evaluating retinal microcirculation called OCT-A (an imaging technique in ophthalmology allowing a precise non-invasive study of the retinal microvascular network) has recently been used by our team to highlight an association between retinal vascularisation and the level of cardiovascular risk in a population of coronary patients without diabetes (6).

We hypothesize that the observation of retinal vascular abnormalities could reflect changes in kidney structure that could underlie chronic renal failure. The aim of this work is thus to evaluate whether the presence of abnormalities in the retinal microvascularisation is 1) predictive of the deterioration in renal function one year after nephrectomy for cancer-related reasons and 2) correlated with renal histological abnormalities.

Registry
clinicaltrials.gov
Start Date
March 18, 2021
End Date
March 5, 2026
Last Updated
5 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patient
  • Indication for total nephrectomy for kidney cancer decided with a multidisciplinary oncology consultation
  • Kidney scan images available
  • Patient affiliated to French national health insurance
  • Patient who has given oral consent

Exclusion Criteria

  • Pregnant woman
  • Ophthalmologic history (macular vascular or degenerative diseases, epiretinal membranes, glaucoma)
  • Cannot sit still for 60 minutes
  • Metastatic cancer
  • Single functional kidney before nephrectomy
  • Estimated Glomerular Filtration Flow Rate (CKD-EPI formula) less than 60 mL/min/1.73m2
  • Diabetes type 1 or type 2
  • Proteinuria at inclusion (or in the 3 months prior to inclusion) on sample with a protein/creatinuria ratio greater than 1g/g or over 24 hours greater than 1g/day
  • HIV, HCV or HBV positive serology
  • Patient subject to a measure of legal protection (guardianship, curatorship, etc.)

Arms & Interventions

patient

Intervention: retinal imaging

patient

Intervention: paraclinical surveillance

Outcomes

Primary Outcomes

Decline in renal function one year after nephrectomy

Time Frame: One year after nephrectomy

defined in a given patient as the occurrence of a Glomerular Filtration Flow Rate (CKD/EPI equation) of less than 60ml/min/1.73 m2

Study Sites (2)

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