Evaluation of the Degradation of Renal Function Post Nephrectomy According to Retinal Vascularisation Parameters (NEPHRIN)
Primary Purpose
Nephrostomy, Retinal Vascularisation
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
retinal imaging
paraclinical surveillance
Sponsored by
About this trial
This is an interventional diagnostic trial for Nephrostomy
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
- 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
Sites / Locations
- Chu Dijon BourgogneRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patient
Arm Description
Outcomes
Primary Outcome Measures
Decline in renal function 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
Secondary Outcome Measures
Full Information
NCT ID
NCT04855123
First Posted
April 19, 2021
Last Updated
May 5, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT04855123
Brief Title
Evaluation of the Degradation of Renal Function Post Nephrectomy According to Retinal Vascularisation Parameters
Acronym
NEPHRIN
Official Title
Evaluation of the Degradation of Renal Function Post Nephrectomy According to Retinal Vascularisation Parameters "NEPHRIN"
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrostomy, Retinal Vascularisation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
retinal imaging
Intervention Description
OCT-angiography, Retinophotography, ocular fundus, Pulsed air tonometer
Intervention Type
Other
Intervention Name(s)
paraclinical surveillance
Intervention Description
blood and urine sampling, assessment of kidney function with creatinine, protein, albumin levels and CKD-EPI equation)
Primary Outcome Measure Information:
Title
Decline in renal function one year after nephrectomy
Description
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
Time Frame
One year after nephrectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu LEGENDRE
Phone
03.80.29.37.56
Ext
+33
Email
mathieu.legendre@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu LEGENDRE
Phone
03.80.29.37.56
Email
mathieu.legendre@chu-dijon.fr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Degradation of Renal Function Post Nephrectomy According to Retinal Vascularisation Parameters
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