Steroid Resistant Nephrotic SyndromePhase 2/3RTX2012NCT01716442
Rituximab Trial for Pediatric Nephrotic Syndrome
A Phase 2/3 study testing Rituximab in people with Steroid Resistant Nephrotic Syndrome and Steroid Dependent Nephrotic Syndrome, run by Seoul National University Childrens Hospital at 1 site in South Korea.
Trial summary
Anti-CD20 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(NS) on the basis of favorable clinical observations. Yet the long-term effect on maintaining remission or the likelihood of becoming rituximab-dependent is unclear and the information on the safety profile of rituximab is limited. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Steroid Resistant Nephrotic Syndrome, Steroid Dependent Nephrotic Syndrome
- What is being tested?
- Rituximab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Nov 2013
- Phase
- Phase 2/3
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- (A)steroid/calcineurin inhibitor resistant nephrotic syndrome
- steroid resistance: no remission after 4 weeks of daily oral corticosteroid (60mg/m2/day)
- calcineurin inhibitor resistance: no remission after 3 months of therapeutic dose administration of cyclosporine and/or tacrolimus
- no remission defined by persistent proteinuria of nephrotic range for the last 3 months
- post-transplant patients were included in the study
- (B)steroid-dependent nephrotic syndrome
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- Steroid-dependent patients who had been on various known medications (such as corticosteroids, cyclophosphamide, chlorambucil, calcineurin inhibitors, levamisole ..) continuously for more than 2 years
- definition of dependency: more than two consecutive relapse events in 2 weeks after discontinuation of steroid or calcineurin inhibitor
- no improvement in relapsing frequency with calcineurin inhibitor use
- unable to continue with calcineurin inhibitor due to side effects
- unable to continue with calcineurin inhibitor due to prolonged use (over 2 years)
- other conditions in which the clinician considers difficult to control disease with steroids or calcineurin inhibitors only.
Who cannot join
- previous rituximab use
- secondary nephrotic syndrome
- estimated GFR <60mL/min/1.73m2 or under 50% of age-matched standard GFR
- chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)
- prior live vaccine inoculation within 1 month (from the study enrollment)
- cardiovascular diseases, pulmonary or pleural diseases
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- uncontrolled hypertension
- leukocytopenia (absolute neutrophil count <1500/mm3) or thrombocytopenia (<75000/mm3)
- pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Children's Hospital
Seoul, 110-740
About this study
Official title: A Multi-center Randomized Controlled Trial of Rituximab for Refractory Nephrotic Syndrome in Children
Anti-CD20 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(NS) on the basis of favorable clinical observations. Yet the long-term effect on maintaining remission or the likelihood of becoming rituximab-dependent is unclear and the information on the safety profile of rituximab is limited. This trial was designed to investigate the safety and efficacy of Rituximab in children with refractory NS.
- Being tested
- Rituximab, Placebo
- Keywords
- rituximab, nephrotic, refractory
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Mabthera, 2005110300291 (rituximab)
Per dose: Rituximab 375 mg/m2 (max.500mg/day). efficacy monitored by CD19 cell count. If CD19 cells are not depleted, second or third doses are given at 2-3 weeks interval.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| steroid-resistant | Active comparator | Steroid-resistant group: n=27 , enroll all for treatment Receives: Drug: Rituximab |
| steroid-dependent-rituximab | Active comparator | steroid-responsive group: n=38 Receives: Drug: Rituximab |
| steroid-dependent-placebo | Placebo comparator | steroid-responsive group: n=23 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment
Measured: within 6 months from the initiation of treatment
The rate of maintaining remission in steroid-dependent nephrotic syndrome patients
Measured: within 6 months from the initiation of treatment versus placebo control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2013 (estimated)
- Study completionNov 2013 (estimated)
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 Steroid Resistant 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Childrens Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Gyung Kang, Seoul National University Childrens Hospital
- Investigators
- Hee Gyung Kang A. Kang, M.D., Ph.D., Principal investigator, Seoul National University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716442
- Sponsor's protocol ID
- RTX-2012
- Acronym
- RTX2012
- Status last verified
- Oct 2012
- First submitted
- 25 Oct 2012
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu ID, Willis NS, Craig JC, Hodson EM. Interventions for idiopathic steroid-resistant nephrotic syndrome in children. Cochrane Database Syst Rev. 2025 May 8;5(5):CD003594. doi: 10.1002/14651858.CD003594.pub7.
PubMed 40337980Larkins 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 39513526
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Controlled Trial of Rituximab for Refractory Nephrotic Syndrome in Children
- ClinicalTrials.gov ID
- NCT01716442
- Acronym / sponsor ID
- RTX2012 / RTX-2012
- Keywords
- rituximab, nephrotic, refractory
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Seoul National University Childrens HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 29 Oct 2012 (estimated)
- 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 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(NS) on the basis of favorable clinical observations. Yet the long-term effect on maintaining remission or the likelihood of becoming rituximab-dependent is unclear and the information on the safety profile of rituximab is limited. This trial was designed to investigate the safety and efficacy of Rituximab in children with refractory NS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| steroid-resistant | Active comparator | Drug: RituximabSteroid-resistant group: n=27 , enroll all for treatment |
| steroid-dependent-rituximab | Active comparator | Drug: Rituximabsteroid-responsive group: n=38 |
| steroid-dependent-placebo | Placebo comparator | Drug: Placebosteroid-responsive group: n=23 |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- (A)steroid/calcineurin inhibitor resistant nephrotic syndrome
- steroid resistance: no remission after 4 weeks of daily oral corticosteroid (60mg/m2/day)
- calcineurin inhibitor resistance: no remission after 3 months of therapeutic dose administration of cyclosporine and/or tacrolimus
- no remission defined by persistent proteinuria of nephrotic range for the last 3 months
- post-transplant patients were included in the study
Key exclusion criteria (9 listed)
- previous rituximab use
- secondary nephrotic syndrome
- estimated GFR <60mL/min/1.73m2 or under 50% of age-matched standard GFR
- chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)
- prior live vaccine inoculation within 1 month (from the study enrollment)
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: Mabthera, 2005110300291 (rituximab)Per dose: Rituximab 375 mg/m2 (max.500mg/day). efficacy monitored by CD19 cell count. If CD19 cells are not depleted, second or third doses are given at 2-3 weeks interval. | Drug | steroid-dependent-rituximab, steroid-resistant |
| Placebo | Drug | steroid-dependent-placebo |
Primary outcome
The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment
Time frame: within 6 months from the initiation of treatment
The rate of maintaining remission in steroid-dependent nephrotic syndrome patients
Time frame: within 6 months from the initiation of treatment versus placebo control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- Derived from this study: PubMed 40337980Liu ID, Willis NS, Craig JC, Hodson EM. Interventions for idiopathic steroid-resistant nephrotic syndrome in children. Cochrane Database Syst Rev. 2025 May 8;5(5):CD003594. doi: 10.1002/14651858.CD003594.pub7.
- 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.
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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.
Hee Gyung Kang A. Kang, M.D., Ph.D. principal investigator
Seoul National University Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rituximab in people with Steroid Resistant Nephrotic Syndrome and Steroid Dependent Nephrotic Syndrome, run by Seoul National University Childrens Hospital at 1 site in South Korea.
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 12 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: status not confirmed, as of the sponsor's last update on 29 Oct 2012. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Hee Gyung A. Kang, M.D., Ph.D. (+82-2072-0658, kanghg1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment (time frame: within 6 months from the initiation of treatment). The study lists 2 primary outcomes in all. 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 NCT01716442, 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 29 Oct 2012.