Trial · NCT01573533
A Pilot Study to Assess the Efficacy of Rituximab Therapy in Treatment Resistant FSGS
NCT01573533, Phase 2, Completed, Mayo Clinic; results first posted 2020-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study to Assess the Efficacy of Rituximab Therapy in Treatment Resistant FSGS. Trials, record NCT01573533. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01573533
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study to Assess the Efficacy of Rituximab Therapy in Treatment Resistant FSGS
- NCT number
- NCT01573533
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Primary Focal Segmental Glomerulosclerosis
- Interventions
- Rituximab
- First posted
- 2012-04-09
- Last updated
- 2020-02-10
- Results first posted
- 2020-02-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Proteinuria (With Stable Renal Function) | Baseline, 12 months | The amount of protein in excreted urine measured by grams per day (g/day). Remission status defined by the following criteria at 12 months: * Complete Remission - Proteinuria \< 0.5 g/day * Partial Remission - Improvement in proteinuria by \> 50% and to a level between 0.5-3.5g/day * Incomplete Remission - Improvement in proteinuria equal to or \>50%, but residual proteinuria still \>3.5g/day |
| Secondary | Change in suPAR Levels | Baseline, 1, 3, 6 and 12 months | SuPAR concentrations will be determined by quantitative ELISA immunoassay reported in picograms per milliliters (pg/ml) |
| Secondary | Change in Activation of Podocyte β3 Integrin | Baseline, 1, 3, 6, 12 months | To quantitatively examine the effect of FSGS patient sera on podocyte β3 integrin activity, a human podocyte cell line is cultured at 37 degrees Celsius for 14 days for complete differentiation. The cells are then incubated in 5-10% of FSGS patient serum for 24 hours with recombinant suPAR protein as a positive control. Cells are fixed with 4% paraformaldehyde (PFA) and proceeded for immunofluorescence staining for AP5 and paxillin. After immunostaining, confocal images are taken to quantify the AP5 and paxillin intensity for each sample treatment. Paxillin signal is used to correct AP5 signal. The relative AP5 signal (AP5/paxillin ratio) from each patient serum is then normalized against that of normal blood donor included in each assay for final report. |
| Secondary | Number of Subjects With Complete or Partial Remission Following Treatment | 12 months | Total number of subjects with complete or partial remission following treatment using the following criteria: * Complete Remission - Proteinuria \< 0.5 g/day * Partial Remission - Improvement in proteinuria by \> 50% and to a level between 0.5-3.5g/day * Incomplete Remission - Improvement in proteinuria equal to or \>50%, but residual proteinuria still \>3.5g/day |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Proteinuria (With Stable Renal Function) | Baseline, 12 months | g/day | MEAN | |
| SECONDARY | Change in suPAR Levels | Baseline, 1, 3, 6 and 12 months | pg/ml | MEAN | |
| SECONDARY | Change in Activation of Podocyte β3 Integrin | Baseline, 1, 3, 6, 12 months | AP5/paxillin ratio | MEAN | |
| SECONDARY | Number of Subjects With Complete or Partial Remission Following Treatment | 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Proteinuria (With Stable Renal Function) | Rituximab | Baseline | 7.6 | Standard Deviation 4.67 | g/day |
| Changes in Proteinuria (With Stable Renal Function) | Rituximab | 12 months | 7.27 | Standard Deviation 7.30 | g/day |
| Change in suPAR Levels | Rituximab | Baseline | 4120 | Standard Deviation 1169 | pg/ml |
| Change in suPAR Levels | Rituximab | 1 month | 3730 | Standard Deviation 1229 | pg/ml |
| Change in suPAR Levels | Rituximab | 3 month | 4231 | Standard Deviation 1871 | pg/ml |
| Change in suPAR Levels | Rituximab | 6 month | 4491 | Standard Deviation 2217 | pg/ml |
| Change in suPAR Levels | Rituximab | 12 month | 3788 | Standard Deviation 1836 | pg/ml |
| Change in Activation of Podocyte β3 Integrin | Rituximab | Baseline | 1.56 | Standard Deviation 0.59 | AP5/paxillin ratio |
| Change in Activation of Podocyte β3 Integrin | Rituximab | 1 month | 1.17 | Standard Deviation 0.17 | AP5/paxillin ratio |
| Change in Activation of Podocyte β3 Integrin | Rituximab | 3 month | 1.13 | Standard Deviation 0.34 | AP5/paxillin ratio |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab | 9 | |
| Overall Study | COMPLETED | Rituximab | 9 | |
| Overall Study | NOT COMPLETED | Rituximab | 0 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Relapse of Nephrotic Syndrome | Renal and urinary disorders | Rituximab | 1 | 9 | 1 |
| other | Infusion related reaction | General disorders | Rituximab | 1 | 9 | 1 |
| other | Nausea | Gastrointestinal disorders | Rituximab | 1 | 9 | 1 |
| other | Vomiting | Gastrointestinal disorders | Rituximab | 1 | 9 | 1 |
| other | Sore Throat | General disorders | Rituximab | 1 | 9 | 1 |
| other | Cramps | General disorders | Rituximab | 1 | 9 | 1 |
| other | Dizziness | General disorders | Rituximab | 1 | 9 | 1 |
| other | Weakness | General disorders | Rituximab | 1 | 9 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab | 1 | 9 | 1 |
| other | Rash | General disorders | Rituximab | 1 | 9 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab | 0 | 9 |
| Total, other adverse events | Rituximab | 9 | 9 |
| Total, serious adverse events | Rituximab | 3 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U54DK083912 | Nephrotic Syndrome Rare Disease Clinical Research Network III | KRETZLER, MATTHIAS | UNIVERSITY OF MICHIGAN AT ANN ARBOR | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2009 to 2023 |
Source NIH RePORTER
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/NCT01573533
GET https://conductscience.org/api/trials/v1/NCT01573533/registered