Fibrillary GlomerulonephritisPhase 4CD20FGNCT06680349
Two Anti-CD20 Regimens for Fibrillary Glomerulonephritis
A Phase 4 study testing Anti-CD20 antibodies in people with Fibrillary Glomerulonephritis, run by University of Turin, Italy at 1 site in Italy.
Trial summary
This study aims to evaluate the clinical and histological effects of two rituximab-based regimens in fibrillary glomerulonephritis. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Fibrillary Glomerulonephritis
- What is being tested?
- Anti-CD20 antibodies
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 2 Jan 2024
- Phase
- Phase 4
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- -Fibrillary glomerulonephritis (biospy proven defined by optical microscopy, immunofluorescence and electron microscopy studies with demonstration of the DNAJB9 protein)
Who cannot join
- previous treatment with anti-CD20; pregnant; unable to consent. other concomitant GN.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the clinical and histological effects of two rituximab-based regimens in fibrillary glomerulonephritis.
- Conditions
- Fibrillary Glomerulonephritis
- Being tested
- Anti-CD20 antibodies
- Keywords
- fibrillary glomerulonephritis, anti-CD20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD20 antibodiesDrug
comparing anti-CD20 (lymphoma protcol, RTX 375 mg/m2 every 4 weeks ) alone Vs. Intensive B-cell depletion therapy (IBCDT) which is based on the combination of RTX (given at the dose of 375 mg/m2 every 4 weeks followed by 2 additional doses after 1 and 2 months), cyclophosphamide (two pulses of 10 mg/kg, corrected according to renal function, on days 4 and 17) and methylprednisolone (three bolus doses of 15 mg/kg) followed by oral prednisone (starting dose 50 mg tapered until complete discontinuation in 4 months).
| Study group | Role | What they receive |
|---|---|---|
| Anti-CD20 alone | Active comparator | Lymphoma Protocol consisting of four weekly doses of 375 mg/m2 of rituximab (RTX) Receives: Drug: Anti-CD20 antibodies |
| IBCDT | Experimental | Intensive B-cell depletion therapy (IBCDT) which is based on the combination of RTX (given at the dose of 375 mg/m2 every 4 weeks followed by 2 additional doses after 1 and 2 months), CYC (two pulses of 10 mg/kg, corrected according to renal function, on days 4 and 17) and methylprednisolone (three bolus doses of 15 mg/kg) followed by oral prednisone (starting dose 50 mg tapered until complete discontinuation in 4 months). Receives: Drug: Anti-CD20 antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal responce
complete remission (CR), i.e., decrease of proteinuria to <0.5g/day with normal or stable renal function (< 20% increase in serum creatinine); partial remission (PR), i.e., reduction in proteinuria by ≥50% with stable renal function
Measured: 0, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Dec 2022
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrillary GlomerulonephritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680349
- Sponsor's protocol ID
- FIBR01
- Acronym
- CD20FG
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 8 Nov 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Anti-CD20 Regimens for Fibrillary Glomerulonephritis
- ClinicalTrials.gov ID
- NCT06680349
- Acronym / sponsor ID
- CD20FG / FIBR01
- Conditions
- Fibrillary Glomerulonephritis
- Keywords
- fibrillary glomerulonephritis, anti-CD20
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 8 Nov 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.
This study aims to evaluate the clinical and histological effects of two rituximab-based regimens in fibrillary glomerulonephritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-CD20 alone | Active comparator | Drug: Anti-CD20 antibodiesLymphoma Protocol consisting of four weekly doses of 375 mg/m2 of rituximab (RTX) |
| IBCDT | Experimental | Drug: Anti-CD20 antibodiesIntensive B-cell depletion therapy (IBCDT) which is based on the combination of RTX (given at the dose of 375 mg/m2 every 4 weeks followed by 2 additional doses after 1 and 2 months), CYC (two pulses of 10 mg/kg, corrected according to renal function, on days 4 and 17) and methylprednisolone (three bolus doses of 15 mg/kg) followed by oral prednisone (starting dose 50 mg tapered until complete discontinuation in 4 months). |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -Fibrillary glomerulonephritis (biospy proven defined by optical microscopy, immunofluorescence and electron microscopy studies with demonstration of the DNAJB9 protein)
Key exclusion criteria (1 listed)
- previous treatment with anti-CD20; pregnant; unable to consent. other concomitant GN.
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 |
|---|---|---|
| Anti-CD20 antibodiescomparing anti-CD20 (lymphoma protcol, RTX 375 mg/m2 every 4 weeks ) alone Vs. Intensive B-cell depletion therapy (IBCDT) which is based on the combination of RTX (given at the dose of 375 mg/m2 every 4 weeks followed by 2 additional doses after 1 and 2 months), cyclophosphamide (two pulses of 10 mg/kg, corrected according to renal function, on days 4 and 17) and methylprednisolone (three bolus doses of 15 mg/kg) followed by oral prednisone (starting dose 50 mg tapered until complete discontinuation in 4 months). | Drug | Anti-CD20 alone, IBCDT |
Primary outcome
renal responce
Time frame: 0, 3 and 6 months
complete remission (CR), i.e., decrease of proteinuria to <0.5g/day with normal or stable renal function (< 20% increase in serum creatinine); partial remission (PR), i.e., reduction in proteinuria by ≥50% with stable renal function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 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. 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 Phase 4 study testing Anti-CD20 antibodies in people with Fibrillary Glomerulonephritis, run by University of Turin, Italy 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 1 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: finished, as of the sponsor's last update on 8 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
renal responce (time frame: 0, 3 and 6 months). 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 8 Nov 2024.