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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04855123

Collaborator

(none)

Enrollment

Location

Arm

11.4

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrostomy Retinal Vascularisation	Other: retinal imaging Other: paraclinical surveillance	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 18, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: patient	Other: retinal imaging OCT-angiography, Retinophotography, ocular fundus, Pulsed air tonometer Other: paraclinical surveillance blood and urine sampling, assessment of kidney function with creatinine, protein, albumin levels and CKD-EPI equation)

Arm

Intervention/Treatment

Other: patient

Other: retinal imaging

OCT-angiography, Retinophotography, ocular fundus, Pulsed air tonometer

Other: paraclinical surveillance

blood and urine sampling, assessment of kidney function with creatinine, protein, albumin levels and CKD-EPI equation)

Outcome Measures

Primary Outcome Measures

Decline in renal function one year after nephrectomy [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Thrombosis of the renal vein
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.)

SECONDARY EXCLUSION CRITERIA

Patient with increased pressure during the measurement of the intraocular pressure before dilation
Patient with histological abnormalities suggestive of nephropathy (excluding nephroangiosclerosis) in the pathological analysis of the nephrectomy sample

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourgogne	Dijon		France	21000

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT04855123

Other Study ID Numbers:

LEGENDRE APJ 2019

First Posted:

Apr 22, 2021

Last Update Posted:

Oct 13, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neovascularization, Pathologic

Study Results

No Results Posted as of Oct 13, 2021