Trial · NCT04585152
Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Idiopathic Nephrotic Syndrome.
NCT04585152, Phase 2, Unknown, Istituto Giannina Gaslini
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Idiopathic Nephrotic Syndrome. Trials, record NCT04585152. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04585152
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Idiopathic Nephrotic Syndrome.
- NCT number
- NCT04585152
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 160 participants, estimated
- Lead sponsor
- Istituto Giannina Gaslini
- Conditions
- Nephrotic Syndrome Steroid-Dependent
- Interventions
- Rituximab Biosimilar
- First posted
- 2020-10-14
- Last updated
- 2022-12-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison between RTX and MMF, considering remission intervals (in months) in the two cohorts | 12-24 months | Comparison between RTX and MMF to maintain remission of NS for 12-24 months in children with primary SDNS. All the participats (n=160) will document their proteinuria and their urine will be analyzed periodically (at least every three months); 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). |
| Secondary | RTX safety by evaluation and documentation of side effects measuring frequency and severity of any treatment-related adverse events as assessed by CTCAE v4.0 | 36 months | 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 |
| Other | Biomarkers of immune competence: mononuclear cells (PBMCs) by cytometry, serum immunoglobulin | 36 months | Identification of biomarkers of response to RTX and immune competence in patients treated with RTX vs. patients treated with MMF. Mononuclear cells (PBMCs) will be characterized by flow cytometry to investigate any difference between the two arms. Samples for cell analysis will be obtained at time 0 and after 3, 12 and 24 months; the same analysis will be performed in case of relapse. In parallel, total IgG, IgA and IgM levels will be recorded. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04585152
GET https://conductscience.org/api/trials/v1/NCT04585152/registered