Nephrotic SyndromePODO-TARGETNCT06718894
Multitarget Strategy for Primary Podocytopathies
A study testing Biologic fluid sampling in people with Nephrotic Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites in Italy.
Trial summary
The goal of this clinical trial is to verify whether a cell culture system can be used to evaluate the presence of a factor capable of causing proteinuria in the serum of patients with primary podocytopathies. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nephrotic Syndrome
- What is being tested?
- Biologic fluid sampling
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- 19 Jun 2025to Nov 2032
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Signature of informed consent for study participation
- One of the following conditions:
- Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) showing clinical and/or histological evidence of post-transplant recurrence.
- Patients with primary podocytopathies (with a histological diagnosis of FSGS or MCD) without clinical and/or histological evidence of post-transplant recurrence.
- Patients with primary podocytopathies in their native kidneys in an active clinical phase of the disease.
- Patients with podocytopathies presenting clinical features compatible with a secondary form due to another condition.
- Patients with glomerulonephritis other than primary podocytopathies (e.g., IgA nephropathy, systemic lupus erythematosus, membranous nephropathy).
- Patients with no history of renal diseases
Who cannot join
- Subjects affected by primary podocytopathies or other glomerulonephritides in clinical remission or with ESRD (eGFR < 15 ml/min) and/or on renal replacement therapy
- Individuals unable to understand and consent to the study procedures
- Any clinical condition that, according to the investigator's judgment, could compromise patient safety during study participation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Giuseppe Castellano, MD, PhD contact
Italy2 sites, 2 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Manuel A Podestà, MD, PhD, 00390255034552, nefrologia@policlinico.mi.it
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
Teresa Rampino, MD, 00390382502591
About this study
The goal of this clinical trial is to verify whether a cell culture system can be used to evaluate the presence of a factor capable of causing proteinuria in the serum of patients with primary podocytopathies. This system will also be used to evaluate the in vitro efficacy of a combined therapy for the treatment of this disorder.
Researchers will compare samples from patients with primary podocytopathies with those obtained from healthy subjects and patients with other renal disorders.
Participants will be asked to visit the clinic at regular intervals for up to 36 months, and to provide blood and urine samples (and a sample of the discarded plasmapheresis effluent in case the procedure is performed).
- Conditions
- Nephrotic Syndrome
- Being tested
- Biologic fluid sampling
- Keywords
- podocytopathy, transplant
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic fluid samplingOther
The only interventions in addition to standard clinical practice will be blood sampling, the collection of morning spot urine and the collection of the discarded effluent of the plasmapheresis procedure (when performed according to clinical indication).
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-culture system capability to distinguish recurrent podocytopathies from healthy subjects
The difference in the increase of albumin permeability in the endothelium-podocyte co-culture system after exposure to serum from patients with recurrent podocytopathies and healthy subjects will be compared.
Measured: Baseline
Secondary outcomes (3)
In-vitro efficacy of SGLT2-inhibitors and uPAR/FPR-inhibitors on primary podocytopathies
Measured: Baseline, 16 weeks and in case of remission/recurrence
Co-culture system capability to distinguish recurrent podocytopathies from other glomerular disorders
The difference in the increase of albumin permeability in the endothelium-podocyte co-culture system after exposure to serum from patients with recurrent podocytopathies and patients with other glomerular disorders will be compared.
Measured: Baseline
Co-culture system reliability in case of podocytopathy remission
The difference in the increase of albumin permeability in the endothelium-podocyte co-culture system after exposure to serum from patients with active podocytopathies and podocytopathies in the remission phase will be compared.
Measured: Baseline, 16 weeks and in case of remission/recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start19 Jun 2025
- Primary completionJan 2032 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Regionale per la Ricerca Biomedica
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718894
- Sponsor's protocol ID
- 5387
- Acronym
- PODO-TARGET
- Status last verified
- Mar 2026
- First submitted
- 2 Dec 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multitarget Strategy for Primary Podocytopathies
- ClinicalTrials.gov ID
- NCT06718894
- Acronym / sponsor ID
- PODO-TARGET / 5387
- Conditions
- Nephrotic Syndrome
- Keywords
- podocytopathy, transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Fondazione Regionale per la Ricerca Biomedica
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 5 Dec 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.
The goal of this clinical trial is to verify whether a cell culture system can be used to evaluate the presence of a factor capable of causing proteinuria in the serum of patients with primary podocytopathies. This system will also be used to evaluate the in vitro efficacy of a combined therapy for the treatment of this disorder.
Researchers will compare samples from patients with primary podocytopathies with those obtained from healthy subjects and patients with other renal disorders.
Participants will be asked to visit the clinic at regular intervals for up to 36 months, and to provide blood and urine samples (and a sample of the discarded plasmapheresis effluent in case the procedure is performed).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Signature of informed consent for study participation
- One of the following conditions:
Key exclusion criteria (3 listed)
- Subjects affected by primary podocytopathies or other glomerulonephritides in clinical remission or with ESRD (eGFR < 15 ml/min) and/or on renal replacement therapy
- Individuals unable to understand and consent to the study procedures
- Any clinical condition that, according to the investigator's judgment, could compromise patient safety during study participation
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 |
|---|---|---|
| Biologic fluid samplingThe only interventions in addition to standard clinical practice will be blood sampling, the collection of morning spot urine and the collection of the discarded effluent of the plasmapheresis procedure (when performed according to clinical indication). | Other | – |
Primary outcome
Co-culture system capability to distinguish recurrent podocytopathies from healthy subjects
Time frame: Baseline
The difference in the increase of albumin permeability in the endothelium-podocyte co-culture system after exposure to serum from patients with recurrent podocytopathies and healthy subjects will be compared.
3 secondary outcomes
In-vitro efficacy of SGLT2-inhibitors and uPAR/FPR-inhibitors on primary podocytopathies
Time frame: Baseline, 16 weeks and in case of remission/recurrence
Co-culture system capability to distinguish recurrent podocytopathies from other glomerular disorders
Time frame: Baseline
Co-culture system reliability in case of podocytopathy remission
Time frame: Baseline, 16 weeks and in case of remission/recurrence
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 27 Mar 2026.
- 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.
Giuseppe Castellano, MD, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biologic fluid sampling in people with Nephrotic Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 2 sites 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 8 inclusion and 3 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 27 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 2 sites 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 Manuel A Podesta', MD, PhD (0039 0255034568, manuel.podesta@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-culture system capability to distinguish recurrent podocytopathies from healthy subjects (time frame: Baseline). 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 Mar 2026.