NephrostomyNEPHRINNCT04855123
Evaluation of the Degradation of Renal Function Post Nephrectomy According to Retinal Vascularisation Parameters
A study testing retinal imaging and paraclinical surveillance in people with Nephrostomy and Retinal Vascularisation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrostomy, Retinal Vascularisation
- What is being tested?
- retinal imaging and paraclinical surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2021to 5 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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) or ischemic parenchymal sequelae of renal vein thrombosis in the pathological analysis of the nephrectomy sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Degradation of Renal Function Post Nephrectomy According to Retinal Vascularisation Parameters "NEPHRIN"
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).
Read more
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.
- Conditions
- Nephrostomy, Retinal Vascularisation
- Being tested
- retinal imaging, paraclinical surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retinal imagingOther
OCT-angiography, Retinophotography, ocular fundus, Pulsed air tonometer
paraclinical surveillanceOther
blood and urine sampling, assessment of kidney function with creatinine, protein, albumin levels and CKD-EPI equation)
| Study group | Role | What they receive |
|---|---|---|
| patient | Other | Not described Receives: Other: retinal imaging; Other: paraclinical surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year after nephrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start18 Mar 2021
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Why it stopped: Changes in clinical practice have led to a decrease in the number of nephrectomies performed in the target population, which has prevented us from recruiting the necessary number of participants within a reasonable timeframe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrostomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855123
- Sponsor's protocol ID
- LEGENDRE APJ 2019
- Acronym
- NEPHRIN
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Degradation of Renal Function Post Nephrectomy According to Retinal Vascularisation Parameters "NEPHRIN"
- ClinicalTrials.gov ID
- NCT04855123
- Acronym / sponsor ID
- NEPHRIN / LEGENDRE APJ 2019
- Conditions
- Nephrostomy, Retinal Vascularisation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changes in clinical practice have led to a decrease in the number of nephrectomies performed in the target population, which has prevented us from recruiting the necessary number of participants within a reasonable timeframe.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | Other | Other: retinal imaging, Other: paraclinical surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retinal imagingOCT-angiography, Retinophotography, ocular fundus, Pulsed air tonometer | Other | patient |
| paraclinical surveillanceblood and urine sampling, assessment of kidney function with creatinine, protein, albumin levels and CKD-EPI equation) | Other | patient |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Changes in clinical practice have led to a decrease in the number of nephrectomies performed in the target population, which has prevented us from recruiting the necessary number of participants within a reasonable timeframe.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retinal imaging and paraclinical surveillance in people with Nephrostomy and Retinal Vascularisation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Changes in clinical practice have led to a decrease in the number of nephrectomies performed in the target population, which has prevented us from recruiting the necessary number of participants within a reasonable timeframe.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decline in renal function one year after nephrectomy (time frame: One year after nephrectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.