Nephrotic Syndrome Steroid-DependentPhase 2NCT04402580
Efficacy of Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome
A Phase 2 study testing Rituximab Biosimilar and Mycophenolate Mofetil in people with Nephrotic Syndrome Steroid-Dependent, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial summary
Anti-CD20 monoclonal antibodies are emerging as the steroid-sparing therapy of choice for nephrotic syndrome. This Randomized Clinical Trial seeks to evaluate whether Rituximab biosimilar maintains drug-free disease remission in patientswith steroid-dependent nephrotic syndrome for 12-24 months and verify its… Read more about this study
- Who is it for?
- Ages 3 to 24 years
- Conditions the study is for
- Nephrotic Syndrome Steroid-Dependent
- What is being tested?
- Rituximab Biosimilar and Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2019to 31 Aug 2020
- Phase
- Phase 2
- 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 3 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- To be eligible for inclusion into this study, participants will have to fulfil the following criteria:
- Age between 3 and 24 years
- Prednison dependent steroid syndrome 0.3-1mg/Kg/day and receive prednisone for at least six months before enrolment. Steroid dependence is defined by two consecutive relapse during corticosteroid therapy or within 14 days of ceasing therapy.
- Ability to provide consent and assent: parents'/guardian's written informed consent, and child's assent given before any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject any time without prejudice to his or her future medical care.
Who cannot join
- Children will be excluded if any of the following criteria apply:
- Positivity to autoimmunity tests (ANA, nDNA, ANCA)
- Reduction of C3 levels.
- eGFR<90/ml/min/1,73 m2 valuated according to revised Bedside Schwartz Formula for patients between 2 and 17 years and with CKD-EPI Creatinine 2009 Equation for 18 years old patients.
- Pregnancy
- Neoplasm
Show all 9Show fewer
- Infections: previous or actual HBV (with HBeAb positivity) or HCV infection
- CD20 B lymphocytes count <2,5%
- Treatment with Rituximab or cyclophosphamide in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Chimeric Monoclonal Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome and Development of Cell Biomarkers Predicting Outcome. The RTX 4 Trial.
Anti-CD20 monoclonal antibodies are emerging as the steroid-sparing therapy of choice for nephrotic syndrome.
This Randomized Clinical Trial seeks to evaluate whether Rituximab biosimilar maintains drug-free disease remission in patientswith steroid-dependent nephrotic syndrome for 12-24 months and verify its superiority vs. mycophenolate mofetil, the reference standard therapy. The investigators will compare the risk of relapse to test this hypothesis (primary outcome). Secondary objectives will include assessing short- and long-term side-effects and developing specific biomarkers of sensitivity to therapy. Patients will be recruited, treated and followed at IRCCS G Gaslini and IRCCS Bambino Gesù where laboratory studies will be performed at in-site facilities
Read the detailed description
Idiopathic nephrotic syndrome (NS) is characterized by proteinuria and hypoalbuminemia associated with dyslipidemia and hypercoagulability. Oral corticosteroids are the cornerstone of therapy and induce disease remission in approximately 90% of cases. However, up to 85% of patients relapse and many develop steroid dependence (SDNS), requiring prolonged dose of steroids to maintain remission. Clinical practice guidelines (KDIGO) suggest using low-dose prednisone to maintain remission in SDNS and Mycophenolate Mofetil (MMF) or calcineurin inhibitors (CNI) as corticosteroid-sparing agents for children who develop steroid adverse effects. Given the toxicity of all these drugs (steroids, CNI and MMF), there is a need to investigate alternative options. Recent evidence supports the use of chimeric anti-CD20 monoclonal antibodies in simple SDNS (Rituximab, RTX).
The RTX4 trial is an open-label, two-parallel-arm, controlled and randomized clinical trial testing the superiority of RTX over MMF in maintaining steroid free disease remission in patients with SDNS.
Eligible participants are children and young adults (age between 3 and 24 years) with nephrotic syndrome who are dependent on prednisone 0.3-1mg/Kg/day and have received prednisone for at least six months before enrolment. Previous treatment with MMF will be allowed. All participants will enter a 45 days run-in period, during which children treated with steroids alone will start MMF 1,200 mg/1,73 sqm orally in 2 daily doses and will taper steroids after 15 days by 0.3 mg/kg per week until complete withdrawal. Patients already receiving MMF alone will continue the treatment. During the same period, instruction on urine collection and dipstick readings will be carefully reviewed and compliance assessed. After run-in period, children will be randomized to either the intervention arm (Rituximab, 375mg/m2) or the comparator arm (continuing or starting MMF). In the intervention arm, 1 month after infusion MMF will be decreased by 50% and withdrawn within 2 additional weeks, whereas MMF will be maintained in the comparator. All patients will be followed for up to 24 months. In case of relapses during this period (see outcome section for definition) patients will be treated with oral prednisone (60 mg/sqm day). Following remission, steroids will be maintained at the initial dose for 7 days and then tapered off by 0.3 mg/kg per week until complete withdrawal in patients of the MMF arm. Patients of the intervention arm will instead be treated with another infusion of RTX (same dose) immediately following steroid-induced remission. After infusion of RTX, steroids will be maintained at the initial dose for 7 days and then tapered off by 0.3 mg/kg per week until complete withdrawal. In this way relapsed patients in both arms will receive the same cumulative dose of prednisone. In case following relapse of proteinuria patients fail to respond to prednisone (they will terminate the study and be considered as treatment failure). The study allows drop-in from one arm to the other after 3 relapses (i.e., investigators will be allowed to use RTX in the comparator arm and vice versa MMF in intervention arm). The economic balance will be calculated on the basis of RTX doses needed to maintain remittance.
All patients will be followed for 24 months. In person visits will occure at enrollment, at T0 (infusion), after 1 month and every 3/6 months later.
The investigators are going to enroll 160 patients.
- Conditions
- Nephrotic Syndrome Steroid-Dependent
- Being tested
- Rituximab Biosimilar, Mycophenolate Mofetil
- Keywords
- nephrotic syndrome treatment, rituximab, Mycophenolate Mofetil
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab BiosimilarDrug
for dosage between 100 and 250 mg Rituximab will be diluted in 100 ml of normal saline and administered at 2 ml/h for the first 30'; 3 ml/h for the second 30'; 6 ml/h for the third 30'; 15 ml/h until the end. For dosage between 260 and 500 mg Rituximab will be diluted in 250 ml of normal saline and administered at 6 ml/h for the first 30'; 9 ml/h for the second 30'; 18 ml/h for the third 30'; 36 ml/h until the end. For dosage between 510 and 1000 mg Rituximab will be diluted in 500 ml of normal saline and administered at 9 ml/h for the first 30'; thereafter, the infusion rate can be doubled every 30 minutes up to a maximum of 72 ml/h.
1,200 mg/1,73 sqm orally divided in 2 daily doses
| Study group | Role | What they receive |
|---|---|---|
| Rituximab biosimilar | Experimental | * Drug Name: Rituximab biosimilar monoclonal anti-CD20 antibody
* Why: Anti-body/antigen interaction results in cell apoptosis and reduced CD20 positive cell related activities (of note CD20 is mostly represented on B cells but also in Th17 cells)
* How: RTX IV: for dosage between 100 and 250 mg Rituximab will be diluted in 100 ml of normal saline and administered at 2 ml/h for the first 30'; 3 ml/h for the second 30'; 6 ml/h for the third 30'; 15 ml/h until the end. For dosage between 260 and 500 mg Rituximab will be diluted in 250 ml of normal saline and administered at 6 ml/h for the first 30'; 9 ml/h for the second 30'; 18 ml/h for the third 30'; 36 ml/h until the end. For dosage between 510 and 1000 mg Rituximab will be diluted in 500 ml of normal saline and administered at 9 ml/h for the first 30'; thereafter, the infusion rate can be doubled every 30 minutes up to a maximum of 72 ml/h.
* Where: in Hospital
* When and how much: once; diluted in 1000 ml of normal saline. Receives: Drug: Rituximab Biosimilar |
| Mycophenolate Mofetil | Active comparator | Drug Name: Mycophenolate Mofetil (MMF)
* Why: selective and reversible inhibition of inosine monophosphate dehydrogenase with inhibition that particularly affects lymphocytes since they rely almost exclusively de novo purine synthesis
* Procedures: MMF 1,200 mg/1,73 sqm orally divided in 2 daily doses Receives: Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between RTX and MMF, considering number of partecipants and relative relapses in the two cohorts
The first expected result of the project is the demonstration that a single infusion of RTX is more likely than MMF to maintain remission of NS for 12-24 months in children with primary SDNS. In order to evaluate the remission, all the partecipats will document their proteinuria, relapse is defined by uPCR ≥2000 mg/g (≥ 200 mg/mmol) or > 3+ protein on urine dipstick for 3 consecutive days (KDIGO Clinical Practice Guideline for Glomerulonephritis, Kidney International Supplement, 2012 2, 163-171) and complete remission is defined by uPCR <200 mg/g (<20 mg/mmol) or o1+ of protein on urine dipstick for 3 consecutive days (KDIGO Clinical Practice Guideline for Glomerulonephritis, Kidney International Supplement, 2012 2, 163-171).
Measured: 12-24 months
Secondary outcomes (1)
RTX safety by evaluation and documentation of side effects
A second result of the study will be based on the side-effects that RTX may induce: the investigators will record and measure frequency and severity of any treatment-related adverse events as assessed by CTCAE v4.0
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Jul 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: due to unexpectedly high rate of relapse in the active comparator arm.
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 Nephrotic Syndrome Steroid-DependentStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The RTX4 trial is an open-label, two-parallel-arm, controlled and randomized clinical trial testing the superiority of RTX over MMF in maintaining steroid free disease remission in patients with SDNS
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Collaborators
- Bambino Gesù Hospital and Research Institute
- Responsible party
- Principal investigator, Gian Marco Ghiggeri MD, PhD, Istituto Giannina Gaslini
- Investigators
- Gianmarco Ghiggeri, MD, Principal investigator, IRCCS Istituto Giannina Gaslini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402580
- Sponsor's protocol ID
- RTX4
- Status last verified
- Sep 2020
- First submitted
- 13 May 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The completed study will be summarized in a final report that accurately and completely presents the study objectives, methods, results, limitations of the study, and interpretation of findings. The first publication will be an in extenso publication of the results of the validation of the project. The Authors of this study protocol will inform the contributing investigators in advance about any plans to publish or present data from this randomized controlled clinical trial. Any publications and presentations of the results (abstract in journals or newspapers, oral presentations, etc.), either in whole or in part, by Investigators or their representatives will require pre-submission review by the Authors of this study protocol.
Publications
Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
PubMed 39513526Ravani P, Lugani F, Drovandi S, Caridi G, Angeletti A, Ghiggeri GM. Rituximab vs Low-Dose Mycophenolate Mofetil in Recurrence of Steroid-Dependent Nephrotic Syndrome in Children and Young Adults: A Randomized Clinical Trial. JAMA Pediatr. 2021 Jun 1;175(6):631-632. doi: 10.1001/jamapediatrics.2020.6150.
PubMed 33616641
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chimeric Monoclonal Anti-CD20 Antibodies (Rituximab Biosimilar) in the Treatment of Childhood Steroid-dependent Nephrotic Syndrome and Development of Cell Biomarkers Predicting Outcome. The RTX 4 Trial.
- ClinicalTrials.gov ID
- NCT04402580
- Acronym / sponsor ID
- RTX4
- Conditions
- Nephrotic Syndrome Steroid-Dependent
- Keywords
- nephrotic syndrome treatment, rituximab, Mycophenolate Mofetil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to unexpectedly high rate of relapse in the active comparator arm.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Collaborators
- Bambino Gesù Hospital and Research Institute
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 27 May 2020 (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.
Anti-CD20 monoclonal antibodies are emerging as the steroid-sparing therapy of choice for nephrotic syndrome.
This Randomized Clinical Trial seeks to evaluate whether Rituximab biosimilar maintains drug-free disease remission in patientswith steroid-dependent nephrotic syndrome for 12-24 months and verify its superiority vs. mycophenolate mofetil, the reference standard therapy. The investigators will compare the risk of relapse to test this hypothesis (primary outcome). Secondary objectives will include assessing short- and long-term side-effects and developing specific biomarkers of sensitivity to therapy. Patients will be recruited, treated and followed at IRCCS G Gaslini and IRCCS Bambino Gesù where laboratory studies will be performed at in-site facilities
Detailed description
Idiopathic nephrotic syndrome (NS) is characterized by proteinuria and hypoalbuminemia associated with dyslipidemia and hypercoagulability. Oral corticosteroids are the cornerstone of therapy and induce disease remission in approximately 90% of cases. However, up to 85% of patients relapse and many develop steroid dependence (SDNS), requiring prolonged dose of steroids to maintain remission. Clinical practice guidelines (KDIGO) suggest using low-dose prednisone to maintain remission in SDNS and Mycophenolate Mofetil (MMF) or calcineurin inhibitors (CNI) as corticosteroid-sparing agents for children who develop steroid adverse effects. Given the toxicity of all these drugs (steroids, CNI and MMF), there is a need to investigate alternative options. Recent evidence supports the use of chimeric anti-CD20 monoclonal antibodies in simple SDNS (Rituximab, RTX).
The RTX4 trial is an open-label, two-parallel-arm, controlled and randomized clinical trial testing the superiority of RTX over MMF in maintaining steroid free disease remission in patients with SDNS.
Eligible participants are children and young adults (age between 3 and 24 years) with nephrotic syndrome who are dependent on prednisone 0.3-1mg/Kg/day and have received prednisone for at least six months before enrolment. Previous treatment with MMF will be allowed. All participants will enter a 45 days run-in period, during which children treated with steroids alone will start MMF 1,200 mg/1,73 sqm orally in 2 daily doses and will taper steroids after 15 days by 0.3 mg/kg per week until complete withdrawal. Patients already receiving MMF alone will continue the treatment. During the same period, instruction on urine collection and dipstick readings will be carefully reviewed and compliance assessed. After run-in period, children will be randomized to either the intervention arm (Rituximab, 375mg/m2) or the comparator arm (continuing or starting MMF). In the intervention arm, 1 month after infusion MMF will be decreased by 50% and withdrawn within 2 additional weeks, whereas MMF will be maintained in the comparator. All patients will be followed for up to 24 months. In case of relapses during this period (see outcome section for definition) patients will be treated with oral prednisone (60 mg/sqm day). Following remission, steroids will be maintained at the initial dose for 7 days and then tapered off by 0.3 mg/kg per week until complete withdrawal in patients of the MMF arm. Patients of the intervention arm will instead be treated with another infusion of RTX (same dose) immediately following steroid-induced remission. After infusion of RTX, steroids will be maintained at the initial dose for 7 days and then tapered off by 0.3 mg/kg per week until complete withdrawal. In this way relapsed patients in both arms will receive the same cumulative dose of prednisone. In case following relapse of proteinuria patients fail to respond to prednisone (they will terminate the study and be considered as treatment failure). The study allows drop-in from one arm to the other after 3 relapses (i.e., investigators will be allowed to use RTX in the comparator arm and vice versa MMF in intervention arm). The economic balance will be calculated on the basis of RTX doses needed to maintain remittance.
All patients will be followed for 24 months. In person visits will occure at enrollment, at T0 (infusion), after 1 month and every 3/6 months later.
The investigators are going to enroll 160 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The RTX4 trial is an open-label, two-parallel-arm, controlled and randomized clinical trial testing the superiority of RTX over MMF in maintaining steroid free disease remission in patients with SDNS
| Arm | Type | Receives |
|---|---|---|
| Rituximab biosimilar | Experimental | Drug: Rituximab Biosimilar* Drug Name: Rituximab biosimilar monoclonal anti-CD20 antibody * Why: Anti-body/antigen interaction results in cell apoptosis and reduced CD20 positive cell related activities (of note CD20 is mostly represented on B cells but also in Th17 cells) * How: RTX IV: for dosage between 100 and 250 mg Rituximab will be diluted in 100 ml of normal saline and administered at 2 ml/h for the first 30'; 3 ml/h for the second 30'; 6 ml/h for the third 30'; 15 ml/h until the end. For dosage between 260 and 500 mg Rituximab will be diluted in 250 ml of normal saline and administered at 6 ml/h for the first 30'; 9 ml/h for the second 30'; 18 ml/h for the third 30'; 36 ml/h until the end. For dosage between 510 and 1000 mg Rituximab will be diluted in 500 ml of normal saline and administered at 9 ml/h for the first 30'; thereafter, the infusion rate can be doubled every 30 minutes up to a maximum of 72 ml/h. * Where: in Hospital * When and how much: once; diluted in 1000 ml of normal saline. |
| Mycophenolate Mofetil | Active comparator | Drug: Mycophenolate MofetilDrug Name: Mycophenolate Mofetil (MMF) * Why: selective and reversible inhibition of inosine monophosphate dehydrogenase with inhibition that particularly affects lymphocytes since they rely almost exclusively de novo purine synthesis * Procedures: MMF 1,200 mg/1,73 sqm orally divided in 2 daily doses |
Who may qualify
- Ages
- 3 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- To be eligible for inclusion into this study, participants will have to fulfil the following criteria:
- Age between 3 and 24 years
- Prednison dependent steroid syndrome 0.3-1mg/Kg/day and receive prednisone for at least six months before enrolment. Steroid dependence is defined by two consecutive relapse during corticosteroid therapy or within 14 days of ceasing therapy.
- Ability to provide consent and assent: parents'/guardian's written informed consent, and child's assent given before any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject any time without prejudice to his or her future medical care.
Key exclusion criteria (9 listed)
- Positivity to autoimmunity tests (ANA, nDNA, ANCA)
- Reduction of C3 levels.
- eGFR<90/ml/min/1,73 m2 valuated according to revised Bedside Schwartz Formula for patients between 2 and 17 years and with CKD-EPI Creatinine 2009 Equation for 18 years old patients.
- Pregnancy
- Neoplasm
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 |
|---|---|---|
| Rituximab Biosimilarfor dosage between 100 and 250 mg Rituximab will be diluted in 100 ml of normal saline and administered at 2 ml/h for the first 30'; 3 ml/h for the second 30'; 6 ml/h for the third 30'; 15 ml/h until the end. For dosage between 260 and 500 mg Rituximab will be diluted in 250 ml of normal saline and administered at 6 ml/h for the first 30'; 9 ml/h for the second 30'; 18 ml/h for the third 30'; 36 ml/h until the end. For dosage between 510 and 1000 mg Rituximab will be diluted in 500 ml of normal saline and administered at 9 ml/h for the first 30'; thereafter, the infusion rate can be doubled every 30 minutes up to a maximum of 72 ml/h. | Drug | Rituximab biosimilar |
| Mycophenolate Mofetil1,200 mg/1,73 sqm orally divided in 2 daily doses | Drug | Mycophenolate Mofetil |
Primary outcome
Comparison between RTX and MMF, considering number of partecipants and relative relapses in the two cohorts
Time frame: 12-24 months
The first expected result of the project is the demonstration that a single infusion of RTX is more likely than MMF to maintain remission of NS for 12-24 months in children with primary SDNS. In order to evaluate the remission, all the partecipats will document their proteinuria, relapse is defined by uPCR ≥2000 mg/g (≥ 200 mg/mmol) or > 3+ protein on urine dipstick for 3 consecutive days (KDIGO Clinical Practice Guideline for Glomerulonephritis, Kidney International Supplement, 2012 2, 163-171) and complete remission is defined by uPCR <200 mg/g (<20 mg/mmol) or o1+ of protein on urine dipstick for 3 consecutive days (KDIGO Clinical Practice Guideline for Glomerulonephritis, Kidney International Supplement, 2012 2, 163-171).
1 secondary outcome
RTX safety by evaluation and documentation of side effects
Time frame: 36 months
Results and safety
The study was stopped early (reason given: due to unexpectedly high rate of relapse in the active comparator arm.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Derived from this study: PubMed 39513526Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
- Derived from this study: PubMed 33616641Ravani P, Lugani F, Drovandi S, Caridi G, Angeletti A, Ghiggeri GM. Rituximab vs Low-Dose Mycophenolate Mofetil in Recurrence of Steroid-Dependent Nephrotic Syndrome in Children and Young Adults: A Randomized Clinical Trial. JAMA Pediatr. 2021 Jun 1;175(6):631-632. doi: 10.1001/jamapediatrics.2020.6150.
- Individual participant dataSharing planned: Yes. The completed study will be summarized in a final report that accurately and completely presents the study objectives, methods, results, limitations of the study, and interpretation of findings. The first publication will be an in extenso publication of the results of the validation of the project. The Authors of this study protocol will inform the contributing investigators in advance about any plans to publish or present data from this randomized controlled clinical trial. Any publications and presentations of the results (abstract in journals or newspapers, oral presentations, etc.), either in whole or in part, by Investigators or their representatives will require pre-submission review by the Authors of this study protocol.
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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.
Gianmarco Ghiggeri, MD principal investigator
IRCCS Istituto Giannina Gaslini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab Biosimilar and Mycophenolate Mofetil in people with Nephrotic Syndrome Steroid-Dependent, run by Istituto Giannina Gaslini 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 4 inclusion and 9 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 14 Sep 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: due to unexpectedly high rate of relapse in the active comparator arm.). 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?
Comparison between RTX and MMF, considering number of partecipants and relative relapses in the two cohorts (time frame: 12-24 months). 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 NCT04402580, 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 14 Sep 2020.