NephropathyNCT06325059
The Role of Renal Progenitors and Polyploid Tubular Cell Response in Glomerular and Tubular Diseases
A study testing Study of renal progenitors in people with Nephropathy, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial summary
Renal progenitors are a subset of parietal epithelial cells (PECs) localized at the urinary pole of Bowman's capsule. Experimental models of podocyte damage showed that PECs can potentially regenerate lost podocytes by migrating from Bowman's capsule to the glomerular tuft, acquiring the morphological and functional… Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Nephropathy
- What is being tested?
- Study of renal progenitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2023to 30 Nov 2047
- Phase
- Interventional
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with glomerular diseases undergoing renal biopsy (e.g., rapidly progressive glomerulonephritis, minimal change disease, focal segmental glomerulosclerosis, diabetic nephropathy, lupus nephritis, membranous nephropathy, IgA nephropathy, etc)
- Patients with AKI, regardless of the nature of the damage (septal, ischemic, toxic, or unknown).
- Signed informed consent form
Who cannot join
- Sample insufficient and/or unavailable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Meyer Children's Hospital IRCCS
Florence
Paola Romagnani
About this study
Official title: Studying the Role of Renal Progenitors and Polyploid Tubular Cell Response in Glomerular and Tubular Diseases: Analysis on Renal Biopsies
Renal progenitors are a subset of parietal epithelial cells (PECs) localized at the urinary pole of Bowman's capsule. Experimental models of podocyte damage showed that PECs can potentially regenerate lost podocytes by migrating from Bowman's capsule to the glomerular tuft, acquiring the morphological and functional features of mature podocytes. Podocyte loss and damage, as well as the inability of PECs to replace lost podocytes, lead to glomerular scarring and chronic kidney disease (CKD) progression.
In addition, the investigators of the present study and others have recently demonstrated the existence of a specific subpopulation of tubular cells in the human kidney with a high potential for regeneration and resistance to death, thus acting as tubular progenitors. These cells are involved in tubular response to damage during acute kidney injury (AKI) trough endoreplication (polyploidization).
Read more
Kidney biopsy is the cornerstone of diagnosis in many kidney diseases leading to CKD and AKI, allowing unambiguous diagnosis in some cases and presumptive diagnosis of ongoing disease in others. Very recently, super resolution imaging techniques proved to maintain current diagnostic standards while allowing to study morphological features of pathophysiological mechanisms of glomerular and tubular diseases.
The rationale of this project is to study the role of renal progenitors (PECs and tubular progenitors) in the pathogenesis of CKD and AKI trough super resolution imaging applied to human renal biopsies, to the aim of identifying relevant connections with clinical data and markers of damage and/or disease progression.
- Conditions
- Nephropathy
- Being tested
- Study of renal progenitors
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of renal progenitorsOther
Evaluation of the role of renal progenitors in pathogenesis and mechanisms of disease progression in kidney biopsies performed for diagnostic purposes
| Study group | Role | What they receive |
|---|---|---|
| Patients with kidney diseases undergoing renal biopsy | Experimental | Patients with kidney diseases undergoing renal biopsy for diagnostic purposes Receives: Other: Study of renal progenitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the role of renal progenitors in the progression of glomerular diseases
The presence renal progenitors will be assessed by immunofluorescence and confocal microscopy on histological sections from renal biopsy performed for diagnostic purposes.
The following features will be assessed and correlated with clinical parameters of renal function:
- number of renal progenitors (CD133+CD24+CD106+ cells/section);
- number of podocyte progenitors (CD133+WT1+, CD24+synaptopodin, CD24+podocin+ cells/section);
- number of activated progenitors in the Bowman's capsule (CD133+SFN+/section)
- quantitative and semiqualitative analysis of the slit diaphragm
- presence and characterization of immune complexes
Measured: Clinical data will be collected at enrollment (kidney biopsy) and at 3, 6 and 12 months from enrollment, then annually until the end of the study (up to 9 years)
Secondary outcomes (2)
Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI)
The presence of tubular progenitors will be assessed by immunofluorescence and confocal microscopy evaluation on histological sections from renal biopsy performed for diagnostic purposes. The presence of polyploid tubular cells will be assessed using specific markers.
In particular, the following features will be assessed:
- number of tubular progenitors (CD133+CD24+CD106- cells) over the total of tubular cells (phaIIoidin+, AQP1+, THP+, AQP2+ cells);
- number of Ki-67+ or PCNA+ over the total of tubular cells (%);
- number of polyploid tubular cells (CDK4+ or CDT1+ and p-H3+) over the total of tubular cells;
Measured: Clinical data will be collected at enrollment (kidney biopsy) and at 3, 6 and 12 months from enrollment, then annually until the end of the study (up to 9 years)
Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI) trough DNA and RNA analysis
The presence of tubular progenitors will be assessed by immunofluorescence and confocal microscopy evaluation on histological sections from renal biopsy performed for diagnostic purposes. The presence of polyploid tubular cells will be assessed using specific markers, in particular:
- DNA content (fluorescence intensity of Picogreen/YAP1 staining);
- RNA expression of polyploidy markers (TMSB10, SEMA5a, VCAM1, BIRC5, AKT, E2F7, E2F8, CDK1, CCNB1)
Measured: Clinical data will be collected at enrollment (kidney biopsy) and at 3, 6 and 12 months from enrollment, then annually until the end of the study (up to 9 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start22 Mar 2023
- Primary completion22 Mar 2047 (estimated)
- Study completion30 Nov 2047 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephropathyStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients affected by nephropathy
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paola Romagnani, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325059
- Sponsor's protocol ID
- BIO-KIDNEY
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying the Role of Renal Progenitors and Polyploid Tubular Cell Response in Glomerular and Tubular Diseases: Analysis on Renal Biopsies
- ClinicalTrials.gov ID
- NCT06325059
- Acronym / sponsor ID
- BIO-KIDNEY
- Conditions
- Nephropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 22 Mar 2047 (estimated)
- Study completion
- 30 Nov 2047 (estimated)
- First posted
- 22 Mar 2024 (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.
Renal progenitors are a subset of parietal epithelial cells (PECs) localized at the urinary pole of Bowman's capsule. Experimental models of podocyte damage showed that PECs can potentially regenerate lost podocytes by migrating from Bowman's capsule to the glomerular tuft, acquiring the morphological and functional features of mature podocytes. Podocyte loss and damage, as well as the inability of PECs to replace lost podocytes, lead to glomerular scarring and chronic kidney disease (CKD) progression.
In addition, the investigators of the present study and others have recently demonstrated the existence of a specific subpopulation of tubular cells in the human kidney with a high potential for regeneration and resistance to death, thus acting as tubular progenitors. These cells are involved in tubular response to damage during acute kidney injury (AKI) trough endoreplication (polyploidization).
Kidney biopsy is the cornerstone of diagnosis in many kidney diseases leading to CKD and AKI, allowing unambiguous diagnosis in some cases and presumptive diagnosis of ongoing disease in others. Very recently, super resolution imaging techniques proved to maintain current diagnostic standards while allowing to study morphological features of pathophysiological mechanisms of glomerular and tubular diseases.
The rationale of this project is to study the role of renal progenitors (PECs and tubular progenitors) in the pathogenesis of CKD and AKI trough super resolution imaging applied to human renal biopsies, to the aim of identifying relevant connections with clinical data and markers of damage and/or disease progression.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients affected by nephropathy
| Arm | Type | Receives |
|---|---|---|
| Patients with kidney diseases undergoing renal biopsy | Experimental | Other: Study of renal progenitorsPatients with kidney diseases undergoing renal biopsy for diagnostic purposes |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with glomerular diseases undergoing renal biopsy (e.g., rapidly progressive glomerulonephritis, minimal change disease, focal segmental glomerulosclerosis, diabetic nephropathy, lupus nephritis, membranous nephropathy, IgA nephropathy, etc)
- Patients with AKI, regardless of the nature of the damage (septal, ischemic, toxic, or unknown).
- Signed informed consent form
Key exclusion criteria (1 listed)
- Sample insufficient and/or unavailable
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 |
|---|---|---|
| Study of renal progenitorsEvaluation of the role of renal progenitors in pathogenesis and mechanisms of disease progression in kidney biopsies performed for diagnostic purposes | Other | Patients with kidney diseases undergoing renal biopsy |
Primary outcome
Evaluation of the role of renal progenitors in the progression of glomerular diseases
Time frame: Clinical data will be collected at enrollment (kidney biopsy) and at 3, 6 and 12 months from enrollment, then annually until the end of the study (up to 9 years)
The presence renal progenitors will be assessed by immunofluorescence and confocal microscopy on histological sections from renal biopsy performed for diagnostic purposes. The following features will be assessed and correlated with clinical parameters of renal function: * number of renal progenitors (CD133+CD24+CD106+ cells/section); * number of podocyte progenitors (CD133+WT1+, CD24+synaptopodin, CD24+podocin+ cells/section); * number of activated progenitors in the Bowman's capsule (CD133+SFN+/section) * quantitative and semiqualitative analysis of the slit diaphragm * presence and characterization of immune complexes
2 secondary outcomes
Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI)
Time frame: Clinical data will be collected at enrollment (kidney biopsy) and at 3, 6 and 12 months from enrollment, then annually until the end of the study (up to 9 years)
Evaluation of the role of tubular endoreplication in mechanisms of acute kidney injury (AKI) trough DNA and RNA analysis
Time frame: Clinical data will be collected at enrollment (kidney biopsy) and at 3, 6 and 12 months from enrollment, then annually until the end of the study (up to 9 years)
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 22 Mar 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study of renal progenitors in people with Nephropathy, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
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 3 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 22 Mar 2024. 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 Italy. 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 Paola Romagnani, MD (055 5662562, paola.romagnani@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the role of renal progenitors in the progression of glomerular diseases (time frame: Clinical data will be collected at enrollment (kidney biopsy) and at 3, 6 and 12 months from enrollment, then annually until the end of the study (up to 9 years)). 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 22 Mar 2024.