Trial · NCT01164098
Rituximab to Prevent Recurrence of Proteinuria
NCT01164098, Phase 3, Terminated, George W. Burke; results first posted 2018-09-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituximab to Prevent Recurrence of Proteinuria. Trials, record NCT01164098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01164098
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab to Prevent Recurrence of Proteinuria
- NCT number
- NCT01164098
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- George W. Burke
- Conditions
- FSGS, Proteinuria
- Interventions
- Rituximab
- First posted
- 2010-07-16
- Last updated
- 2018-09-20
- Results first posted
- 2018-09-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30. | between post-transplant day 3 and day 30 | Primary Outcome - Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30 will be compared between the two treatment arms using an intent-to-treat approach. |
| Secondary | Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 | Post-Transplant Months 3-12 | Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 will be compared between the two treatment arms using an intent-to-treat approach. |
| Secondary | Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate) | 12 months post-transplant | Renal function as measured by eGFR (estimated glomerular filtration rate) using the MDRD formula |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30. | between post-transplant day 3 and day 30 | Intent-to-Treat Analysis | ratio | GEOMETRIC_MEAN |
| SECONDARY | Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 | Post-Transplant Months 3-12 | Intent-to-Treat Analysis | ratio | GEOMETRIC_MEAN |
| SECONDARY | Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate) | 12 months post-transplant | Intent-to-Treat Analysis | ml/min/1.73 m^2 | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30. | Rituximab | 1.44 | Standard Error 1.33 | ratio | |
| Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30. | No Rituximab | 2.85 | Standard Error 1.52 | ratio | |
| Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 | Rituximab | 0.50 | Standard Error 1.53 | ratio | |
| Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 | No Rituximab | 0.35 | Standard Error 1.34 | ratio | |
| Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate) | Rituximab | 57.1 | Standard Error 8.4 | ml/min/1.73 m^2 | |
| Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate) | No Rituximab | 66.9 | Standard Error 6.6 | ml/min/1.73 m^2 |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab | 15 | |
| Overall Study | STARTED | No Rituximab | 15 | |
| Overall Study | COMPLETED | Rituximab | 15 | |
| Overall Study | COMPLETED | No Rituximab | 15 | |
| Overall Study | NOT COMPLETED | Rituximab | 0 | |
| Overall Study | NOT COMPLETED | No Rituximab | 0 |
Source ClinicalTrials.gov
Adverse events142
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 | Abnormal GGT | Investigations | Rituximab | 1 | 15 | |
| other | Abnormal GGT | Investigations | No Rituximab | 1 | 15 | |
| other | Acute Anemia | Blood and lymphatic system disorders | Rituximab | 1 | 15 | |
| other | Acute Anemia | Blood and lymphatic system disorders | No Rituximab | 1 | 15 | |
| other | Acute T Cell Mediated Rejection | Immune system disorders | Rituximab | 0 | 15 | |
| other | Acute T Cell Mediated Rejection | Immune system disorders | No Rituximab | 1 | 15 | |
| other | Anemia | Blood and lymphatic system disorders | Rituximab | 3 | 15 | |
| other | Anemia | Blood and lymphatic system disorders | No Rituximab | 3 | 15 | |
| other | Ascites | Hepatobiliary disorders | Rituximab | 0 | 15 | |
| other | Ascites | Hepatobiliary disorders | No Rituximab | 1 | 15 |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab | 0 | 15 |
| Total, all-cause mortality | No Rituximab | 0 | 15 |
| Total, other adverse events | Rituximab | 11 | 15 |
| Total, other adverse events | No Rituximab | 13 | 15 |
| Total, serious adverse events | Rituximab | 2 | 15 |
| Total, serious adverse events | No Rituximab | 0 | 15 |
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 |
|---|---|---|---|---|---|
| R01DK090316 | Novel Targets of Rituximab in FSGS | FORNONI, ALESSIA | UNIVERSITY OF MIAMI SCHOOL OF MEDICINE | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2011 to 2015 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rituximab vs No Rituximab: deaths from any cause | Trial comparisons |
| Rituximab vs No Rituximab: serious adverse events | Trial comparisons |
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/NCT01164098
GET https://conductscience.org/api/trials/v1/NCT01164098/events?page=2