Renal Transplant RejectionNCT00695097
The Effect of Rituximab on the Development of Anti-Donor Antibodies
A study testing Rituximab and No Rituximab in people with Renal Transplant Rejection, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The aim of the study is to find out if Rituximab, which is an antibody against specific white cells involved in rejection, when combined with standard anti-rejection treatment can more effectively reverse the rejection process. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplant Rejection
- What is being tested?
- Rituximab and No Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients of a kidney transplant or kidney-pancreas transplant with predominant findings on kidney biopsy of acute rejection and the presence of as B cells by immunohistochemistry
- Patients between 18 and 65 years of age
- Patients known not to be allergic to Rituximab
- Able and willing to give written informed consent and comply with the requirements of the study protocol
- Adequate renal function as indicated by serum creatinine less than 6 mg/dL
- negative serum pregnancy test (for women of child bearing age)
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- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
- Patients who have received a kidney-pancreas transplant.
- Patients who on immunohistochemistry have evidence of B cell infiltration
Who cannot join
- Patients who have undergoing multi-organ transplant except for kidney-pancreas patients.
- Patients who have been administered an experimental drug in the 3 months preceding enrollment in the study
- Receipt of a live vaccine within 4 weeks prior to randomization
- Previous Treatment with Rituximab (MabThera® / Rituxan®)
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- History of HIV (positive HIV, HIV conducted during screening if applicable)
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- History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)
- History of recurrent significant infection or history of recurrent bacterial infections
- Known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within 6 months prior to screening
- Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment)
- Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma insitu of the cervix.
- History of psychiatric disorder being treated with medications
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease) Laboratory Exclusion Criteria (at Screening)
- Hemoglobin: < 7 gm/dL
- Platelets: < 100,000/mm
- Known history of positive Hepatitis B or C serology
- Known history of positive HIV
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
UCSF-Kidney Transplant Clinic
San Francisco, California, 94143
About this study
Official title: The Effect of Rituximab on the Development of Anti-Donor Antibodies and Resolution of B Cell Infiltration in the Renal Allograft of Patients Undergoing Rejection
The aim of the study is to find out if Rituximab, which is an antibody against specific white cells involved in rejection, when combined with standard anti-rejection treatment can more effectively reverse the rejection process.
Our hypothesis is that with acute rejection there is activation of B cells and the subsequent development of anti-donor antibodies that ultimately lead to graft loss. More effective therapy targeted at B cells may abort the development of anti-HLA antibodies, prevent renal injury and have a favorable effect on long-term graft outcome.
Read the detailed description
This is a two center, randomized pilot study of the effects of Rituximab on treatment of acute rejection. A total of 24 patients (including patients transplanted at University of California San Francisco and University of Alabama Birmingham) will be enrolled in the study, 16 randomized to Rituximab and 8 to no-Rituximab (control arm). Fifteen (15) subjects will be recruited at UCSF with 10 patients randomized to Rituximab and 5 to no-Rituximab (control arm). If either center is a slow enroller the patient mix could be altered.
Procedures:
This is an open label trial of patients with rejection with B cell infiltrates on kidney biopsy who will be randomized to either receive Rituximab or no Rituximab in and 2:1 ratio. Patients who have rejection on kidney biopsy and on immunohistochemistry there is evidence of B cells infiltration will be enrolled in the study and randomized 2:1 to receive Rituximab or no Rituximab. Rituximab will be administered in 2 doses of 1,000 mg. The first dose will be administered while the patient is still in the hospital being treated for rejection and the second dose will be administered 2 weeks later in the outpatient facility in the GCRC at UCSF. The patients' acute rejection episode will be treated according to standard therapy as per the treating transplant physician. Below is the table (table 1) detailing when the patient will have blood drawn for flow cytometry, anti-HLA antibodies, PK studies, serum creatinine as well as 24 hour urine protein. At 3 months after enrollment in the study, the patient will undergo a follow-up biopsy to determine the extent of the resolution of the cellular infiltrate.
- Conditions
- Renal Transplant Rejection
- Being tested
- Rituximab, No Rituximab
- Keywords
- Rituximab, Renal Transplant Rejection, B cells, Patients with biopsy proven acute rejection cellular infiltrate, B cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
Rituximab infusion on Day 1 and Day 15
No RituximabDrug
No Rituximab
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Rituximab Group: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15) and followed up monthly for 1 year. Biopsy was done Baseline and Month 3 and other labs (CBC/Diff, Platelets, HACA, PK, Serum Creatinine, 24-hour protein, HLA antibodies, flow cytometry, and serology testing). Physical exam and vital signs were done. Receives: Drug: Rituximab |
| 2 | Active comparator | No Rituximab: received standard immunosuppression and was followed up monthly for 1 year. Labs (CBC/Diff, Platelets, HACA, PK, Serum Creatinine, 24-hour protein, HLA antibodies, flow cytometry, and serology testing) vital signs, and physical exam was done. Receives: Drug: No Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Biopsy Cell Densities From Baseline to Follow-up
Follow-up biopsy was done 3-6 months after study treatment. Study follow-up monthly for 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startAug 2004
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Transplant RejectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Flavio Vincenti, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695097
- Sponsor's protocol ID
- GNE Rituxin
- Status last verified
- Feb 2014
- First submitted
- 9 Jun 2008
- Last updated
- 26 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rituximab on the Development of Anti-Donor Antibodies and Resolution of B Cell Infiltration in the Renal Allograft of Patients Undergoing Rejection
- ClinicalTrials.gov ID
- NCT00695097
- Acronym / sponsor ID
- GNE Rituxin
- Conditions
- Renal Transplant Rejection
- Keywords
- Rituximab, Renal Transplant Rejection, B cells, Patients with biopsy proven acute rejection cellular infiltrate, B cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Posted 26 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to find out if Rituximab, which is an antibody against specific white cells involved in rejection, when combined with standard anti-rejection treatment can more effectively reverse the rejection process.
Our hypothesis is that with acute rejection there is activation of B cells and the subsequent development of anti-donor antibodies that ultimately lead to graft loss. More effective therapy targeted at B cells may abort the development of anti-HLA antibodies, prevent renal injury and have a favorable effect on long-term graft outcome.
Detailed description
This is a two center, randomized pilot study of the effects of Rituximab on treatment of acute rejection. A total of 24 patients (including patients transplanted at University of California San Francisco and University of Alabama Birmingham) will be enrolled in the study, 16 randomized to Rituximab and 8 to no-Rituximab (control arm). Fifteen (15) subjects will be recruited at UCSF with 10 patients randomized to Rituximab and 5 to no-Rituximab (control arm). If either center is a slow enroller the patient mix could be altered.
Procedures:
This is an open label trial of patients with rejection with B cell infiltrates on kidney biopsy who will be randomized to either receive Rituximab or no Rituximab in and 2:1 ratio. Patients who have rejection on kidney biopsy and on immunohistochemistry there is evidence of B cells infiltration will be enrolled in the study and randomized 2:1 to receive Rituximab or no Rituximab. Rituximab will be administered in 2 doses of 1,000 mg. The first dose will be administered while the patient is still in the hospital being treated for rejection and the second dose will be administered 2 weeks later in the outpatient facility in the GCRC at UCSF. The patients' acute rejection episode will be treated according to standard therapy as per the treating transplant physician. Below is the table (table 1) detailing when the patient will have blood drawn for flow cytometry, anti-HLA antibodies, PK studies, serum creatinine as well as 24 hour urine protein. At 3 months after enrollment in the study, the patient will undergo a follow-up biopsy to determine the extent of the resolution of the cellular infiltrate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: RituximabRituximab Group: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15) and followed up monthly for 1 year. Biopsy was done Baseline and Month 3 and other labs (CBC/Diff, Platelets, HACA, PK, Serum Creatinine, 24-hour protein, HLA antibodies, flow cytometry, and serology testing). Physical exam and vital signs were done. |
| 2 | Active comparator | Drug: No RituximabNo Rituximab: received standard immunosuppression and was followed up monthly for 1 year. Labs (CBC/Diff, Platelets, HACA, PK, Serum Creatinine, 24-hour protein, HLA antibodies, flow cytometry, and serology testing) vital signs, and physical exam was done. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Recipients of a kidney transplant or kidney-pancreas transplant with predominant findings on kidney biopsy of acute rejection and the presence of as B cells by immunohistochemistry
- Patients between 18 and 65 years of age
- Patients known not to be allergic to Rituximab
- Able and willing to give written informed consent and comply with the requirements of the study protocol
- Adequate renal function as indicated by serum creatinine less than 6 mg/dL
Key exclusion criteria (19 listed)
- Patients who have undergoing multi-organ transplant except for kidney-pancreas patients.
- Patients who have been administered an experimental drug in the 3 months preceding enrollment in the study
- Receipt of a live vaccine within 4 weeks prior to randomization
- Previous Treatment with Rituximab (MabThera® / Rituxan®)
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
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: RituxanRituximab infusion on Day 1 and Day 15 | Drug | 1 |
| No RituximabNo Rituximab | Drug | 2 |
Primary outcome
Change in Biopsy Cell Densities From Baseline to Follow-up
Time frame: 1 year
Follow-up biopsy was done 3-6 months after study treatment. Study follow-up monthly for 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Flavio Vincenti, M.D. principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab and No Rituximab in people with Renal Transplant Rejection, run by University of California, San Francisco at 2 sites in United States.
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 9 inclusion and 19 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: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Biopsy Cell Densities From Baseline to Follow-up (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.