Acute Kidney InjuryNEPHROCTNCT05728216
Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings for the Diagnosis of Either Acute Kidney Injury or Chronic Kidney Disease in Routine Practices (NEPHROCT)
An observational study of Acute Kidney Injury and Chronic Kidney Diseases, run by Centre Hospitalier William Morey - Chalon sur Saône at 1 site in France.
Trial summary
Kidney biopsy play a key role for the investigation of either acute kidney injury or chronic kidney disease. Despite possible complications due to the invasive nature of the biopsy, such procedure is still essential in a number of clinical situations to improve the diagnosis specificity of kidney disease, better… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Diseases, Tomography, Optical Coherence
- What is being tested?
- Dynamic full-field optical coherence tomography analysis of kidney biopsy
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2022to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: patients > 18 years of age with suspected acute kidney injury or chronic kidney disease requiring biopsy in the nephrology department
Who may be able to join
- patients > 18 years of age with suspected acute kidney injury requiring biopsy in the nephrology department
- patients > 18 years of age with suspected chronic kidney disease requiring biopsy in the nephrology department
Who cannot join
- inability to perform dynamic full-field optical coherence tomography observation at the moment of kidney biopsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Quentin Bernard contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier William Morey - Chalon sur Saône
Chalon-sur-Saône, Saône-et-Loire, 71100
Thomas Maldiney, +33 3 85 91 01 11, thomas.maldiney@ch-chalon71.fr
About this study
Official title: Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings for the Diagnosis of Either Acute Kidney Injury or Chronic Kidney Disease in Routine Practices
Kidney biopsy play a key role for the investigation of either acute kidney injury or chronic kidney disease. Despite possible complications due to the invasive nature of the biopsy, such procedure is still essential in a number of clinical situations to improve the diagnosis specificity of kidney disease, better inform about its prognosis and guide the management of a future treatment. Pursuing the idea to improve both performance and rapidity associated with the histopathological analysis of kidney biopsy, with a possible recourse to artificial intelligence-based renal pathology, the present study intends to assess the impact of direct histopathological examination of kidney biopsy with dynamic full-field optical coherence tomography in routine practices for the diagnosis of either acute kidney injury or chronic kidney disease.
- Being tested
- Dynamic full-field optical coherence tomography analysis of kidney biopsy
- Keywords
- Tomography, Optical Coherence, Chronic Kidney Diseases, Acute Kidney Injury, Kidney Biopsy
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic full-field optical coherence tomography analysis of kidney biopsyOther
Dynamic full-field optical coherence tomography analysis of kidney biopsy in the nephrology department before conventional histopathological analysis
| Study group | Role | What they receive |
|---|---|---|
| NEPHROCT cohort | Patients > 18 years of age with suspected acute kidney injury or chronic kidney disease requiring biopsy in the nephrology department Receives: Other: Dynamic full-field optical coherence tomography analysis of kidney biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological analysis of elementary lesions in nephropathology with dynamic full-field optical coherence tomography
Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and characterize common glomerular (abnormal / double contour of the glomerular basement membrane, focal segmental glomerulosclerosis, collapse of the glomerular tuft, proliferation of glomerular epithelial cells, endocapillary proliferation, mesangial expansion, necrosis and proliferation with mild increase in extracapillary cells...), vascular (hyaline change, fibrinoid change / necrosis, thrombosis, inflammation or necrosis of vascular walls, arteriosclerosis) and tubulointerstitial (acute tubular necrosis, cytoplasmic vacuolization, lipid inclusions in proximal / distal tubular cells, atrophy of tubules, edema, inflammation or interstitial fibrosis, cortical necrosis) lesions seen in kidney biopsy
Measured: Outcome measure is assessed 15 days following kidney biopsy
Secondary outcomes (1)
Histopathological analysis of healthy kidney biopsy with dynamic full-field optical coherence tomography
Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and characterize healthy glomerular (glomerular basement membrane, glomerular tuft, endothelial, epithelial, and mesangial cells, glomerular capsule and capsular space, glomerular capillaries), vascular (afferent and efferent arterioles, interlobular artery) and tubulointerstitial (proximal and distal tubular cells, normal cytoplasmic aspect) structures seen in kidney biopsy
Measured: Outcome measure is assessed 15 days following kidney biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Nov 2022
- Primary completion31 Oct 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier William Morey - Chalon sur Saône
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Responsible party
- Principal investigator, Thomas Maldiney, Centre Hospitalier William Morey - Chalon sur Saône
- Investigators
- Thomas Maldiney, Principal investigator, Centre Hospitalier William Morey - Chalon sur Saône
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728216
- Sponsor's protocol ID
- NEPHROCT
- Acronym
- NEPHROCT
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hull KL, Adenwalla SF, Topham P, Graham-Brown MP. Indications and considerations for kidney biopsy: an overview of clinical considerations for the non-specialist. Clin Med (Lond). 2022 Jan;22(1):34-40. doi: 10.7861/clinmed.2021-0472. Epub 2021 Dec 17.
PubMed 34921054Jain M, Robinson BD, Salamoon B, Thouvenin O, Boccara C, Mukherjee S. Rapid evaluation of fresh ex vivo kidney tissue with full-field optical coherence tomography. J Pathol Inform. 2015 Sep 28;6:53. doi: 10.4103/2153-3539.166014. eCollection 2015.
PubMed 26605118
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings for the Diagnosis of Either Acute Kidney Injury or Chronic Kidney Disease in Routine Practices
- ClinicalTrials.gov ID
- NCT05728216
- Acronym / sponsor ID
- NEPHROCT / NEPHROCT
- Keywords
- Tomography, Optical Coherence, Chronic Kidney Diseases, Acute Kidney Injury, Kidney Biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier William Morey - Chalon sur SaôneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 15 Feb 2023 (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.
Kidney biopsy play a key role for the investigation of either acute kidney injury or chronic kidney disease. Despite possible complications due to the invasive nature of the biopsy, such procedure is still essential in a number of clinical situations to improve the diagnosis specificity of kidney disease, better inform about its prognosis and guide the management of a future treatment. Pursuing the idea to improve both performance and rapidity associated with the histopathological analysis of kidney biopsy, with a possible recourse to artificial intelligence-based renal pathology, the present study intends to assess the impact of direct histopathological examination of kidney biopsy with dynamic full-field optical coherence tomography in routine practices for the diagnosis of either acute kidney injury or chronic kidney disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEPHROCT cohort | – | Other: Dynamic full-field optical coherence tomography analysis of kidney biopsyPatients > 18 years of age with suspected acute kidney injury or chronic kidney disease requiring biopsy in the nephrology department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients > 18 years of age with suspected acute kidney injury or chronic kidney disease requiring biopsy in the nephrology department
Key inclusion criteria (2 listed)
- patients > 18 years of age with suspected acute kidney injury requiring biopsy in the nephrology department
- patients > 18 years of age with suspected chronic kidney disease requiring biopsy in the nephrology department
Key exclusion criteria (1 listed)
- inability to perform dynamic full-field optical coherence tomography observation at the moment of kidney biopsy
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 |
|---|---|---|
| Dynamic full-field optical coherence tomography analysis of kidney biopsyDynamic full-field optical coherence tomography analysis of kidney biopsy in the nephrology department before conventional histopathological analysis | Other | NEPHROCT cohort |
Primary outcome
Histopathological analysis of elementary lesions in nephropathology with dynamic full-field optical coherence tomography
Time frame: Outcome measure is assessed 15 days following kidney biopsy
Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and characterize common glomerular (abnormal / double contour of the glomerular basement membrane, focal segmental glomerulosclerosis, collapse of the glomerular tuft, proliferation of glomerular epithelial cells, endocapillary proliferation, mesangial expansion, necrosis and proliferation with mild increase in extracapillary cells...), vascular (hyaline change, fibrinoid change / necrosis, thrombosis, inflammation or necrosis of vascular walls, arteriosclerosis) and tubulointerstitial (acute tubular necrosis, cytoplasmic vacuolization, lipid inclusions in proximal / distal tubular cells, atrophy of tubules, edema, inflammation or interstitial fibrosis, cortical necrosis) lesions seen in kidney biopsy
1 secondary outcome
Histopathological analysis of healthy kidney biopsy with dynamic full-field optical coherence tomography
Time frame: Outcome measure is assessed 15 days following kidney biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 34921054Hull KL, Adenwalla SF, Topham P, Graham-Brown MP. Indications and considerations for kidney biopsy: an overview of clinical considerations for the non-specialist. Clin Med (Lond). 2022 Jan;22(1):34-40. doi: 10.7861/clinmed.2021-0472. Epub 2021 Dec 17.
- Background: PubMed 26605118Jain M, Robinson BD, Salamoon B, Thouvenin O, Boccara C, Mukherjee S. Rapid evaluation of fresh ex vivo kidney tissue with full-field optical coherence tomography. J Pathol Inform. 2015 Sep 28;6:53. doi: 10.4103/2153-3539.166014. eCollection 2015.
- Individual participant dataSharing planned: Undecided
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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.
Quentin Bernard contact
Thomas Maldiney principal investigator
Centre Hospitalier William Morey - Chalon sur Saône
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Chronic Kidney Diseases, run by Centre Hospitalier William Morey - Chalon sur Saône 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 18 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Maldiney (+33 3 85 91 01 11, thomas.maldiney@ch-chalon71.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathological analysis of elementary lesions in nephropathology with dynamic full-field optical coherence tomography (time frame: Outcome measure is assessed 15 days following kidney biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05728216, which also lists 2 linked publications.
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 18 Mar 2026.