Minimal Change Nephrotic Syndrome (MCNS)Phase 2RIFIREINSNCT03970577
RItuximab From the FIRst Episode of Idiopathic Nephrotic Syndrome
A Phase 2 study testing Rituximab and Prednisone in people with Minimal Change Nephrotic Syndrome (MCNS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Minimal change nephrotic syndrome (MCNS) is an acquired glomerular disease characterized by massive proteinuria occurring in the absence of glomerular inflammatory lesions or immunoglobulin deposits. MCNS represents a frequent cause of nephrotic syndrome (NS) in adults (10% to 25% of cases). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimal Change Nephrotic Syndrome (MCNS)
- What is being tested?
- Rituximab and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2020to 29 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥ 18 years
- First episode of Minimal change nephrotic syndrome defined as albumin level < 30 g/L and urine protein/creatinine ratio (UCPR) ≥ 300mg/mmol
- Biopsy-proven MCNS defined on renal biopsy examination by the presence of minimal change glomerular lesions and absence of segmental sclerosis by light microscopy, negative immunofluorescence, or presence of IgM deposits into the mesangium
- Signed informed consent to participate in the study
- Patients who are affiliated with the French health care system
Who cannot join
- Previous administration of Rituximab therapy
- MCNS resulting from a secondary process (lymphoid disorders or malignant disease) or potentially related to treatment known to be associated with MCNS occurrence (Lithium, Interferon, non-steroidal anti-inflammatory drugs)
- Patients with acute infections or chronic active infections
- Positive serological screening test for HIV, B or C hepatitis
- Positive immunological tests for antinuclear and anti-DNA antibodies
- Usual contraindication to steroid or Rituximab
Show all 26Show fewer
- Immunosuppressed patients, patients with a severe immune deficit
- Patients with hypersensitivity to a monoclonal antibody or biological agents
- Patients with a known allergy to steroid and its excipients or to Rituximab and its excipients or to acetaminophen and its excipients or to cetirizine and its excipients or to protein of murine origin
- Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
- Patients who have white blood cell count ≤4,000/mm3,
- Patients who have platelet count ≤100,000/mm3,
- Patients who have haemoglobin level <9g/dL,
- Patients who have SGOT or SGPT or bilirubin level greater than 3 times the upper limit of normal
- Patients who have serum creatinine level >150 µmol/l,
- Patients with active cancer or recent cancer (<5 years),
- Females of childbearing potential who don't have an effective method of birth control during the study and during the next 12 months after treatment stop
- Women who are pregnant (positive βHCG at inclusion), or who plan to become pregnant whilst in the trial
- Breastfeeding women
- Severe heart failure (New York Heart Association Class III and IV) or severe, uncontrolled cardiac disease
- Patients who participate simultaneously in another interventional trial
- Patients not willing or able to comply with the protocol requirements
- Patients who are under tutorship or curatorship
- Non randomization criteria
- Absence of complete remission after 8 weeks of treatment by steroids (CR is defined as albumin level > 30 g/L and urine protein/creatinine ratio <30mg/mmol ).
- Positive βHCG at randomization (after 8 weeks of treatment by steroids)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rituximab From the First Episode of Minimal Change Nephrotic Syndrome for Preventing Relapse Risk in Adult Patients: a Multicenter Randomized Controlled Trial
Minimal change nephrotic syndrome (MCNS) is an acquired glomerular disease characterized by massive proteinuria occurring in the absence of glomerular inflammatory lesions or immunoglobulin deposits. MCNS represents a frequent cause of nephrotic syndrome (NS) in adults (10% to 25% of cases). The disease typically takes a chronic course characterized by frequent relapses. Until now, exclusive oral steroid therapy at the dose of 1mg/kg/day (max 80 mg/day) for a minimum of 4 weeks and a maximum of 16 weeks (as tolerated) constitutes the first line treatment of adults with MCNS. Despite of successful remission of initial episode, previous case series showed that 56%-76% of patients experience at least one relapse after steroid-induced remission. The recent MSN trial prospectively showed that 57.9% and 70% of adult patients were in complete remission (CR) after 4 and 8 weeks of oral steroids therapy (1mg/kg/day). Among them, 23.1% of patients displayed at least one relapse episode (after one year-follow-up). Although well tolerated, side effects are common in patients with prolonged and/or repeated courses of steroids and alternative regimens seem highly suitable to reduce the risk of subsequent relapse. Rituximab has recently emerged as a promising therapeutic option in patients with steroids dependent-MCNS. In a multicenter, double-blind, randomized, placebo-controlled trial in children with frequent relapse or with steroid dependent NS, the authors found that the median relapse free period was significantly longer in the Rituximab group than in the placebo group without significant differences concerning serious adverse events. To our knowledge, its use has never been investigated for the initial episode of MCNS with the aim to reduce the subsequent risk of relapse that is a major concern in the management of MCNS patients.
The main objective is to demonstrate, from initial episode of MCNS in adults, once complete remission has occurred, that the use of Rituximab (two injections separated by one week 375mg/m2, with definitive steroids withdrawal after 9 weeks of treatment) may reduce the risk of subsequent MCNS relapse after 12 months of follow-up and may be a safe and an efficient treatment regimen.
Read more
The study will be a single stage phase IIb, randomized, open-label, parallel group, in a 1:1 ratio, active controlled, multicenter trial testing the efficacy and safety of two injections of Rituximab separated by one week 375mg/m2 from initial episode of biopsy-proven MCNS in adults. Since Rituximab therapy (when initiated in a context of steroid dependency MCNS) seems to be more effective in patients with complete remission and because of recent data from MSN trial showing that 70% of patients were in complete remission of nephrotic syndrome after 8 weeks of steroids, we decided to maximize the potential benefit, to perform randomization of patients after 8 weeks of steroid treatment. A potential risk factor of relapse is the time of CR occurrence, and because some patients reach CR at 4 weeks and others at 8 weeks, a randomization (1:1) with minimization strategy will be done in order to balance this factor between arms. The primary endpoint will be the incidence of MCNS relapse during the 12 months following randomization defined by the recurrence of nephrotic syndrome (urine protein/creatinine ratio (UPCR) ≥ 300mg/mmol and decreased albumin level (< 30 g/L) in a patient who was in complete remission.
Rituximab is currently considered as an effective therapeutic option to maintain remission in patients with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS). The goal of this prospective study is to determine the potential interest of the use of Rituximab from the initial episode of MCNS to reduce the risk of subsequent relapse, that is a major concern in the management of MCNS patients.
- Conditions
- Minimal Change Nephrotic Syndrome (MCNS)
- Being tested
- Rituximab, Prednisone
- Keywords
- Minimal Change Nephrotic syndrome, Rituximab, Relapse rate
- Medical subject headings
- Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Mabthéra
Two injections of Rituximab (375mg/m2) separated by one week (one at time of randomization and the other one week after) and definitive withdrawal of steroid at the time of second injection of Rituximab (for a total steroids exposure of 9 weeks)
PrednisoneDrug
Also called Cortancyl
exclusive oral steroid therapy (progressively tapered with the same procedure for all patients) for a total exposure of 24 weeks (taking into account the initial oral steroid therapy administered during 8 weeks in addition with the oral steroid treatment given after randomization). Each patient will be followed up until 18 months after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab treatment | Experimental | Two injections of Rituximab (375mg/m2) separated by one week (one at time of randomization and the other one week after) and definitive withdrawal of steroid at the time of second injection of Rituximab (for a total steroids exposure of 9 weeks) Receives: Drug: Rituximab |
| Oral steroid treatment | Active comparator | The patients will continue exclusive oral steroid treatment, that will be progressively tapered, for a total of 24 weeks (by taking into account the initial oral steroid therapy administered during 8 weeks and the oral steroid treatment given after randomization).
Each patient will be followed up until 18 months after randomization. The patient will have study visits at inclusion, 4 weeks and 8 weeks after inclusion. At the time of randomization, patients who will have reached CR of MCNS will be allocated in test or control group and will be followed up similarly: visits at 1, 4, 16, 24 weeks, 12 and 18 months after randomization. Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MCNS relapse during the 12 months following randomization
defined by the recurrence of nephrotic syndrome (urine protein/creatinine ratio (UPCR) ≥ 300mg/mmol and decreased albumin level (< 30 g/L) in a patient who was in complete remission
Measured: 12 months following randomization
Secondary outcomes (5)
The relapse rate
The relapse rate by 18 months of follow-up after randomization
Measured: 18 months after randomization
Type of adverse events (AEs) and serious adverse events (SAEs)
Measured: 18 months
Frequency of adverse events (AEs) and serious adverse events (SAEs)
Measured: 18 months
Severity of adverse events (AEs) and serious adverse events (SAEs) assessed by the CTCAE version 4.0
The AEs will be recorded by 18 months after randomization and graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Measured: 18 months
Treatment Burden questionnaire (TBQ) © (Ravaud et al, 2012)
The TBQ is a validated questionnaire exploring burden associated with taking medicine, self-monitoring, laboratory exams, medical visits, need for organization, administrative tasks, following advice on diet and physical activity, and social and financial impact of the treatment TBQ is composed of 15 items with rating scale ranging from 0 (best outcome ("not a problem")) to 10 (worst outcome ("large problem")) and an open-ended question. It is unidimensional and a global score (sum of answers to each item) is calculated.
4 weeks before randomization, 1 week after randomization (i.e. end of treatment for experimental arm) and 16 weeks after randomization (i.e. time of steroids cessation for control arm). The baseline level of treatment burden is assessed at Week -4 (instead of W0 randomization) to avoid a learning bias because the questionnaire would have been administered at time points W0 and W1.
Measured: 4 weeks before randomization, 1 week after randomization and 16 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start29 Jul 2020
- Primary completion29 Nov 2023 (estimated)
- Study completion29 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Minimal Change Nephrotic Syndrome (MCNS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a single stage phase IIb, randomized, open-label, parallel group, in a 1:1 ratio, active controlled, multicenter trial testing the efficacy and safety of two injections of Rituximab separated by one week (375mg/m2) from initial episode of MCNS in adults. The control arm is a standard regimen of oral steroid alone (progressively tapered within 24 weeks). At inclusion, all patients will receive oral steroid therapy (Prednisone, 1mg/kg/day, maximum 80 mg/day). For patients without complete remission after 4 weeks of treatment, prednisone will be continued at the same dose until the 8th week. For patients with complete remission after 4 weeks of treatment, doses of prednisone will be progressively reduced between the 4th and the 8th week (0.06 mg/kg by week). Patients who reach complete remission by 8 weeks after inclusion will be randomized at this time to receive either Rituximab (experimental group) or the standard steroid regimen (control group).
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent AUDARD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970577
- Sponsor's protocol ID
- P170922J
- Other IDs
- 2018-003437-15, 2018
- Acronym
- RIFIREINS
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2019
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Publications
Liaukouskaya N, Hengel FE, Muhlig A, Tomas NM, Huber TB. A New Hope for Treating Podocytopathies: Emerging Role of Anti-Nephrin Antibody. Clin J Am Soc Nephrol. 2026 Jan 21. doi: 10.2215/CJN.0000001008. Online ahead of print.
PubMed 41563842Gauckler P, Matyjek A, Kapsia S, Marinaki S, Quintana LF, Diaz MM, King C, Griffin S, Ramachandran R, Odler B, Eller K, Artan AS, Mirioglu S, Busch M, Schaepe M, Turkmen K, Cheung CK, Pepper RJ, Juarez GF, Pascual J, Aunon P, Garcia-Carro C, Rodriguez A, Alberici F, Luzardo L, Chebotareva N, Schonermarck U, Fernandez L, Radhakrishnan J, Guaman K, Peleg Y, Hoisnard L, Audard V, Papasotiriou M, Krnanska N, Tesar V, Hruskova Z, Bruchfeld A, Stangou M, Lioulios G, Faguer S, Ribes D, Salhi S, Windpessl M, Galesic K, Crnogorac M, Zagorec N, Mayer G, Kronbichler A; RITERM Study Team. Long-Term Outcomes of Rituximab-Treated Adult Patients with Podocytopathies. J Am Soc Nephrol. 2025 Apr 1;36(4):668-678. doi: 10.1681/ASN.0000000520. Epub 2024 Oct 16.
PubMed 39431468Christian MT, Maxted AP. Optimizing the corticosteroid dose in steroid-sensitive nephrotic syndrome. Pediatr Nephrol. 2022 Jan;37(1):37-47. doi: 10.1007/s00467-021-04985-1. Epub 2021 Feb 20.
PubMed 33611671
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab From the First Episode of Minimal Change Nephrotic Syndrome for Preventing Relapse Risk in Adult Patients: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03970577
- Acronym / sponsor ID
- RIFIREINS / P170922J
- Conditions
- Minimal Change Nephrotic Syndrome (MCNS)
- Keywords
- Minimal Change Nephrotic syndrome, Rituximab, Relapse rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 29 Nov 2023 (estimated)
- Study completion
- 29 Nov 2023 (estimated)
- First posted
- 31 May 2019 (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.
Minimal change nephrotic syndrome (MCNS) is an acquired glomerular disease characterized by massive proteinuria occurring in the absence of glomerular inflammatory lesions or immunoglobulin deposits. MCNS represents a frequent cause of nephrotic syndrome (NS) in adults (10% to 25% of cases). The disease typically takes a chronic course characterized by frequent relapses. Until now, exclusive oral steroid therapy at the dose of 1mg/kg/day (max 80 mg/day) for a minimum of 4 weeks and a maximum of 16 weeks (as tolerated) constitutes the first line treatment of adults with MCNS. Despite of successful remission of initial episode, previous case series showed that 56%-76% of patients experience at least one relapse after steroid-induced remission. The recent MSN trial prospectively showed that 57.9% and 70% of adult patients were in complete remission (CR) after 4 and 8 weeks of oral steroids therapy (1mg/kg/day). Among them, 23.1% of patients displayed at least one relapse episode (after one year-follow-up). Although well tolerated, side effects are common in patients with prolonged and/or repeated courses of steroids and alternative regimens seem highly suitable to reduce the risk of subsequent relapse. Rituximab has recently emerged as a promising therapeutic option in patients with steroids dependent-MCNS. In a multicenter, double-blind, randomized, placebo-controlled trial in children with frequent relapse or with steroid dependent NS, the authors found that the median relapse free period was significantly longer in the Rituximab group than in the placebo group without significant differences concerning serious adverse events. To our knowledge, its use has never been investigated for the initial episode of MCNS with the aim to reduce the subsequent risk of relapse that is a major concern in the management of MCNS patients.
The main objective is to demonstrate, from initial episode of MCNS in adults, once complete remission has occurred, that the use of Rituximab (two injections separated by one week 375mg/m2, with definitive steroids withdrawal after 9 weeks of treatment) may reduce the risk of subsequent MCNS relapse after 12 months of follow-up and may be a safe and an efficient treatment regimen.
The study will be a single stage phase IIb, randomized, open-label, parallel group, in a 1:1 ratio, active controlled, multicenter trial testing the efficacy and safety of two injections of Rituximab separated by one week 375mg/m2 from initial episode of biopsy-proven MCNS in adults. Since Rituximab therapy (when initiated in a context of steroid dependency MCNS) seems to be more effective in patients with complete remission and because of recent data from MSN trial showing that 70% of patients were in complete remission of nephrotic syndrome after 8 weeks of steroids, we decided to maximize the potential benefit, to perform randomization of patients after 8 weeks of steroid treatment. A potential risk factor of relapse is the time of CR occurrence, and because some patients reach CR at 4 weeks and others at 8 weeks, a randomization (1:1) with minimization strategy will be done in order to balance this factor between arms. The primary endpoint will be the incidence of MCNS relapse during the 12 months following randomization defined by the recurrence of nephrotic syndrome (urine protein/creatinine ratio (UPCR) ≥ 300mg/mmol and decreased albumin level (< 30 g/L) in a patient who was in complete remission.
Rituximab is currently considered as an effective therapeutic option to maintain remission in patients with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS). The goal of this prospective study is to determine the potential interest of the use of Rituximab from the initial episode of MCNS to reduce the risk of subsequent relapse, that is a major concern in the management of MCNS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a single stage phase IIb, randomized, open-label, parallel group, in a 1:1 ratio, active controlled, multicenter trial testing the efficacy and safety of two injections of Rituximab separated by one week (375mg/m2) from initial episode of MCNS in adults. The control arm is a standard regimen of oral steroid alone (progressively tapered within 24 weeks). At inclusion, all patients will receive oral steroid therapy (Prednisone, 1mg/kg/day, maximum 80 mg/day). For patients without complete remission after 4 weeks of treatment, prednisone will be continued at the same dose until the 8th week. For patients with complete remission after 4 weeks of treatment, doses of prednisone will be progressively reduced between the 4th and the 8th week (0.06 mg/kg by week). Patients who reach complete remission by 8 weeks after inclusion will be randomized at this time to receive either Rituximab (experimental group) or the standard steroid regimen (control group).
| Arm | Type | Receives |
|---|---|---|
| Rituximab treatment | Experimental | Drug: RituximabTwo injections of Rituximab (375mg/m2) separated by one week (one at time of randomization and the other one week after) and definitive withdrawal of steroid at the time of second injection of Rituximab (for a total steroids exposure of 9 weeks) |
| Oral steroid treatment | Active comparator | Drug: PrednisoneThe patients will continue exclusive oral steroid treatment, that will be progressively tapered, for a total of 24 weeks (by taking into account the initial oral steroid therapy administered during 8 weeks and the oral steroid treatment given after randomization). Each patient will be followed up until 18 months after randomization. The patient will have study visits at inclusion, 4 weeks and 8 weeks after inclusion. At the time of randomization, patients who will have reached CR of MCNS will be allocated in test or control group and will be followed up similarly: visits at 1, 4, 16, 24 weeks, 12 and 18 months after randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged ≥ 18 years
- First episode of Minimal change nephrotic syndrome defined as albumin level < 30 g/L and urine protein/creatinine ratio (UCPR) ≥ 300mg/mmol
- Biopsy-proven MCNS defined on renal biopsy examination by the presence of minimal change glomerular lesions and absence of segmental sclerosis by light microscopy, negative immunofluorescence, or presence of IgM deposits into the mesangium
- Signed informed consent to participate in the study
- Patients who are affiliated with the French health care system
Key exclusion criteria (26 listed)
- Previous administration of Rituximab therapy
- MCNS resulting from a secondary process (lymphoid disorders or malignant disease) or potentially related to treatment known to be associated with MCNS occurrence (Lithium, Interferon, non-steroidal anti-inflammatory drugs)
- Patients with acute infections or chronic active infections
- Positive serological screening test for HIV, B or C hepatitis
- Positive immunological tests for antinuclear and anti-DNA antibodies
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 |
|---|---|---|
| RituximabAlso: MabthéraTwo injections of Rituximab (375mg/m2) separated by one week (one at time of randomization and the other one week after) and definitive withdrawal of steroid at the time of second injection of Rituximab (for a total steroids exposure of 9 weeks) | Drug | Rituximab treatment |
| PrednisoneAlso: Cortancylexclusive oral steroid therapy (progressively tapered with the same procedure for all patients) for a total exposure of 24 weeks (taking into account the initial oral steroid therapy administered during 8 weeks in addition with the oral steroid treatment given after randomization). Each patient will be followed up until 18 months after randomization. | Drug | Oral steroid treatment |
Primary outcome
Incidence of MCNS relapse during the 12 months following randomization
Time frame: 12 months following randomization
defined by the recurrence of nephrotic syndrome (urine protein/creatinine ratio (UPCR) ≥ 300mg/mmol and decreased albumin level (< 30 g/L) in a patient who was in complete remission
5 secondary outcomes
The relapse rate
Time frame: 18 months after randomization
Type of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 18 months
Frequency of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 18 months
Severity of adverse events (AEs) and serious adverse events (SAEs) assessed by the CTCAE version 4.0
Time frame: 18 months
Treatment Burden questionnaire (TBQ) © (Ravaud et al, 2012)
Time frame: 4 weeks before randomization, 1 week after randomization and 16 weeks after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Derived from this study: PubMed 41563842Liaukouskaya N, Hengel FE, Muhlig A, Tomas NM, Huber TB. A New Hope for Treating Podocytopathies: Emerging Role of Anti-Nephrin Antibody. Clin J Am Soc Nephrol. 2026 Jan 21. doi: 10.2215/CJN.0000001008. Online ahead of print.
- Derived from this study: PubMed 39431468Gauckler P, Matyjek A, Kapsia S, Marinaki S, Quintana LF, Diaz MM, King C, Griffin S, Ramachandran R, Odler B, Eller K, Artan AS, Mirioglu S, Busch M, Schaepe M, Turkmen K, Cheung CK, Pepper RJ, Juarez GF, Pascual J, Aunon P, Garcia-Carro C, Rodriguez A, Alberici F, Luzardo L, Chebotareva N, Schonermarck U, Fernandez L, Radhakrishnan J, Guaman K, Peleg Y, Hoisnard L, Audard V, Papasotiriou M, Krnanska N, Tesar V, Hruskova Z, Bruchfeld A, Stangou M, Lioulios G, Faguer S, Ribes D, Salhi S, Windpessl M, Galesic K, Crnogorac M, Zagorec N, Mayer G, Kronbichler A; RITERM Study Team. Long-Term Outcomes of Rituximab-Treated Adult Patients with Podocytopathies. J Am Soc Nephrol. 2025 Apr 1;36(4):668-678. doi: 10.1681/ASN.0000000520. Epub 2024 Oct 16.
- Derived from this study: PubMed 33611671Christian MT, Maxted AP. Optimizing the corticosteroid dose in steroid-sensitive nephrotic syndrome. Pediatr Nephrol. 2022 Jan;37(1):37-47. doi: 10.1007/s00467-021-04985-1. Epub 2021 Feb 20.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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.
Vincent AUDARD principal investigator
Assistance Publique - Hôpitaux de Paris
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 and Prednisone in people with Minimal Change Nephrotic Syndrome (MCNS), run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 13 Jul 2021. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent AUDARD, MD, PhD (+33(1)49 81 44 46, vincent.audard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MCNS relapse during the 12 months following randomization (time frame: 12 months following randomization). 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 NCT03970577, which also lists 3 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 13 Jul 2021.