Trial · NCT00307125
Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies
NCT00307125, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2015-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies. Trials, record NCT00307125. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00307125
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies
- NCT number
- NCT00307125
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 757 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Kidney Transplant, Kidney Transplant Recipient, Graft Function/Survival, de Novo HLA Antibodies Development
- Interventions
- Rituximab plus immunosuppression, Placebo plus immunosuppression
- First posted
- 2006-03-27
- Last updated
- 2026-09-24
- Results first posted
- 2015-03-23
- Limitations and caveats
Slow accrual. In order to ensure the study was completed within the time frame allotted, randomization to the control arm (Pilot Phase-Placebo plus immunosuppression) was suspended. Enrollment continued to lag. The study was stopped early.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | During Screening Phase: Incidence of Alloantibody Development | During screening window of 3-60 months post kidney transplant | Data were analyzed for 653 participants from the screening phase of the study. This outcome looked at the number of kidney transplant recipients that developed de novo HLA antibodies (anti-HLA Ab) post-transplant. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection. |
| Primary | During Screening Phase: Timing of Alloantibody Development | During screening window of 3-60 months post kidney transplant | Data were analyzed for 653 participants from the screening phase of the study. Of these, 79 (12%) developed de novo HLA-antibodies (anti-HLA Ab). This outcome looks at the average length of time (interval) from post kidney transplant until development of alloantibody. Alloantibody is defined as an antibody produced following the introduction of an alloantigen into the system of an individual lacking that particular antigen. Alloantibodies are important mediators of acute and chronic rejection |
| Primary | Number of Participants With 50 Percent (%) Decrease in Circulating Anti-Human Leukocyte Antigen (HLA) Antibodies | 1 year post treatment initiation | Number of participants with 50% decrease in circulating anti-HLA antibodies at any time within the first 12 months post kidney transplant by LuminexTM Beads Method. Luminex assays for quantitation and detection of cytokine and signal transduction proteins. Presence of circulating antibodies is indicative of the transplant recipient's immune system responding to the transplanted organ as a foreign object or infection. |
| Secondary | Number of Deaths 12 Months Post Treatment Initiation | 12 months post treatment initiation | Number of participant deaths within 12 months post treatment initiation |
| Secondary | Number of Participants Experiencing Graft Loss 12 Months Post Treatment Initiation | 1 year post treatment initiation | Number of participants with graft loss, defined as the need for dialysis for greater than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure within 12 month post treatment initiation |
| Secondary | Number of Participants Experiencing Biopsy-proven Post-Transplant Lymphoproliferative Disease (PTLD) | 1 year post treatment initiation | Number of participants with PTLD within 12 month post treatment initiation. Diagnosis of PTLD was made by B cell proliferation after therapeutic immunosuppression. |
| Secondary | Number of Participants Experiencing Loss of Peritubular Capillary (PTC) C4d Staining on Kidney Biopsy | 1 year post treatment initiation | Number of participants with loss of PTC C4d staining on kidney (renal) biopsy within 12 months post treatment initiation. PTC C4d staining on biopsy indicates organ rejection. |
| Secondary | Number of Participants With Viral Replication of Cytomegalovirus (CMV) | 1 year post treatment initiation | Number of participants with viral replication of CMV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of active CMV infection. |
| Secondary | Number of Participants With Evidence of Viral Replication of Epstein-Barr Virus (EBV) | 1 year post treatment initiation | Number of participants with positive viral replication of EBV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of EBV viral replication is indicative of active infection. |
| Secondary | Number of Participants With Viral Replication of Polyomavirus (BKV) | 1 year post treatment initiation | Number of participants with viral replication of BKV within 12 month post treatment initiation. Measured by polymerase chain reaction (PCR) method. Evidence of viral replication is indicative of a BKV infection. Polyomavirus BK is a significant pathogen in transplant recipients. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | During Screening Phase: Incidence of Alloantibody Development | During screening window of 3-60 months post kidney transplant | Screening sample | participants | NUMBER |
| PRIMARY | During Screening Phase: Timing of Alloantibody Development | During screening window of 3-60 months post kidney transplant | Screening sample | Months | MEAN |
| PRIMARY | Number of Participants With 50 Percent (%) Decrease in Circulating Anti-Human Leukocyte Antigen (HLA) Antibodies | 1 year post treatment initiation | Intent-to-treat | participants | NUMBER |
| SECONDARY | Number of Deaths 12 Months Post Treatment Initiation | 12 months post treatment initiation | Intent-to-treat | participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Graft Loss 12 Months Post Treatment Initiation | 1 year post treatment initiation | Intent-to-treat | participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Biopsy-proven Post-Transplant Lymphoproliferative Disease (PTLD) | 1 year post treatment initiation | Intent-to-treat | participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Loss of Peritubular Capillary (PTC) C4d Staining on Kidney Biopsy | 1 year post treatment initiation | Intent-to-treat | participants | NUMBER |
| SECONDARY | Number of Participants With Viral Replication of Cytomegalovirus (CMV) | 1 year post treatment initiation | Intent-to-treat | participants | NUMBER |
| SECONDARY | Number of Participants With Evidence of Viral Replication of Epstein-Barr Virus (EBV) | 1 year post treatment initiation | Intent-to-treat | participants | NUMBER |
| SECONDARY | Number of Participants With Viral Replication of Polyomavirus (BKV) | 1 year post treatment initiation | Intent-to-treat | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| During Screening Phase: Incidence of Alloantibody Development | Screening Phase | 79 | participants | ||
| During Screening Phase: Timing of Alloantibody Development | Screening Phase | 16.2 | Standard Deviation 9.9 | Months | |
| Number of Participants With 50 Percent (%) Decrease in Circulating Anti-Human Leukocyte Antigen (HLA) Antibodies | Pilot Phase-Rituximab Plus Immunosuppression | 2 | participants | ||
| Number of Participants With 50 Percent (%) Decrease in Circulating Anti-Human Leukocyte Antigen (HLA) Antibodies | Pilot Phase-Placebo Plus Immunosuppression | 0 | participants | ||
| Number of Deaths 12 Months Post Treatment Initiation | Pilot Phase-Rituximab Plus Immunosuppression | 0 | participants | ||
| Number of Deaths 12 Months Post Treatment Initiation | Pilot Phase-Placebo Plus Immunosuppression | 0 | participants | ||
| Number of Participants Experiencing Graft Loss 12 Months Post Treatment Initiation | Rituximab Plus Immunosuppression | 0 | participants | ||
| Number of Participants Experiencing Graft Loss 12 Months Post Treatment Initiation | Placebo Plus Immunosuppression | 0 | participants | ||
| Number of Participants Experiencing Biopsy-proven Post-Transplant Lymphoproliferative Disease (PTLD) | Pilot Phase-Rituximab Plus Immunosuppression | 0 | participants | ||
| Number of Participants Experiencing Biopsy-proven Post-Transplant Lymphoproliferative Disease (PTLD) | Pilot Phase-Placebo Plus Immunosuppression | 0 | participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening Phase | STARTED | Screening Phase | 757 | |
| Screening Phase | STARTED | Pilot Phase-Rituximab Plus Immunosuppression | 0 | |
| Screening Phase | STARTED | Pilot Phase-Placebo Plus Immunosuppression | 0 | |
| Screening Phase | COMPLETED | Screening Phase | 303 | |
| Screening Phase | COMPLETED | Pilot Phase-Rituximab Plus Immunosuppression | 0 | |
| Screening Phase | COMPLETED | Pilot Phase-Placebo Plus Immunosuppression | 0 | |
| Screening Phase | NOT COMPLETED | Screening Phase | 454 | |
| Screening Phase | NOT COMPLETED | Pilot Phase-Rituximab Plus Immunosuppression | 0 | |
| Screening Phase | NOT COMPLETED | Pilot Phase-Placebo Plus Immunosuppression | 0 | |
| Pilot Phase | STARTED | Screening Phase | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events18
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 | Diarrhoea | Gastrointestinal disorders | Pilot Phase-Rituximab Plus Immunosuppression | 2 | 15 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Pilot Phase-Placebo Plus Immunosuppression | 1 | 7 | 1 |
| other | Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Pilot Phase-Rituximab Plus Immunosuppression | 1 | 15 | 1 |
| other | Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Pilot Phase-Placebo Plus Immunosuppression | 1 | 7 | 1 |
| serious | Duodenal fistula | Gastrointestinal disorders | Pilot Phase-Rituximab Plus Immunosuppression | 0 | 15 | 0 |
| serious | Duodenal fistula | Gastrointestinal disorders | Pilot Phase-Placebo Plus Immunosuppression | 1 | 7 | 1 |
| serious | Infusion related reaction | General disorders | Pilot Phase-Rituximab Plus Immunosuppression | 1 | 15 | 1 |
| serious | Infusion related reaction | General disorders | Pilot Phase-Placebo Plus Immunosuppression | 0 | 7 | 0 |
| serious | Transplant rejection | Immune system disorders | Pilot Phase-Rituximab Plus Immunosuppression | 1 | 15 | 1 |
| serious | Transplant rejection | Immune system disorders | Pilot Phase-Placebo Plus Immunosuppression | 0 | 7 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pilot Phase-Rituximab Plus Immunosuppression | ||
| Total, all-cause mortality | Pilot Phase-Placebo Plus Immunosuppression | ||
| Total, other adverse events | Pilot Phase-Rituximab Plus Immunosuppression | 3 | 15 |
| Total, other adverse events | Pilot Phase-Placebo Plus Immunosuppression | 2 | 7 |
| Total, serious adverse events | Pilot Phase-Rituximab Plus Immunosuppression | 5 | 15 |
| Total, serious adverse events | Pilot Phase-Placebo Plus Immunosuppression | 1 | 7 |
Source ClinicalTrials.gov
Papers4
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rituximab Plus Immunosuppression vs Placebo Plus Immunosuppression: Number of Participants Experiencing Graft Loss 12 Months Post Treatment Initiation | Trial comparisons |
| Pilot Phase-Rituximab Plus Immunosuppression vs Pilot Phase-Placebo Plus Immunosuppression: Number of Participants Experiencing Loss of Peritubular Capillary (PTC) C4d Staining on Kidney Biopsy | Trial comparisons |
| Pilot Phase-Rituximab Plus Immunosuppression vs Pilot Phase-Placebo Plus Immunosuppression: Number of Participants Experiencing Biopsy-proven Post-Transplant Lymphoproliferative Disease (PTLD) | Trial comparisons |
| Pilot Phase-Rituximab Plus Immunosuppression vs Pilot Phase-Placebo Plus Immunosuppression: Number of Deaths 12 Months Post Treatment Initiation | Trial comparisons |
Pilot Phase-Rituximab Plus Immunosuppression vs Pilot Phase-Placebo Plus Immunosuppression: Number of Participants With 50 Percent (%) Decrease in Circulating Anti-Human Leukocyte Antigen (HLA) Antibodies | Trial comparisons |
| Pilot Phase-Rituximab Plus Immunosuppression vs Pilot Phase-Placebo Plus Immunosuppression: 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/NCT00307125
GET https://conductscience.org/api/trials/v1/NCT00307125/results?page=2