Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies (NCT00307125) | Clinical Trial Compass
CompletedPhase 2
Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies
United States757 participantsStarted 2006-03
Plain-language summary
The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of the transplanted kidney.The pilot study compares the use of rituximab (Rituxan®) + site-specific standard immunosuppression to placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after transplant.
Who can participate
Age range
5 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Stage 1 Inclusion Criteria for All Participants:
* Willing to provide informed consent
* Previously diagnosed end stage renal disease (ESRD)
* Received kidney transplant within 3 and 36 months of study entry
* Willing to comply with the study protocol
* Willing to use acceptable forms of contraception during the study and for 12 months following rituximab/placebo therapy
* Willing to refrain from breastfeeding during the study and for 12 months following rituximab therapy
Stage 1 Inclusion Criteria for Pediatric Participants (\<\\=18 Years of Age):
* Parent or guardian willing to provide informed consent
* Have received all childhood vaccinations prior to study entry
Stage 2 Inclusion Criteria for Pilot Treatment Study:
* Three to 39 months post-transplant
* Developed new antibodies detected at two time points within 1 month between 3 to 36 months post-transplant
* Negative pregnancy test
Stage 1 Exclusion Criteria for All Participants:
* Recipient of a kidney from a donor older than 70 years of age
* Multi-organ transplant
* History of organ transplantation other than current kidney transplantation
* Previous treatment with rituximab
* History of severe allergic reactions to monoclonal antibodies
* History of allergic reaction to iodine glomerular filtration rate (GFR) assay
* Lack of intravenous (IV) access
* Sensitized to greater than 5% Panel Reactive Antibody (PRA) within 12 weeks prior to transplant
* History of recurrent bacterial or other significant infections…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
During Screening Phase: Incidence of Alloantibody Development
Timeframe: During screening window of 3-60 months post kidney transplant
2
During Screening Phase: Timing of Alloantibody Development
Timeframe: During screening window of 3-60 months post kidney transplant
3
Number of Participants With 50 Percent (%) Decrease in Circulating Anti-Human Leukocyte Antigen (HLA) Antibodies
Timeframe: 1 year post treatment initiation
Trial details
NCT IDNCT00307125
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)