Can a B-Cell drug stop antibodies from attacking a new kidney?
NCT ID NCT00307125
First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time
Summary
After a kidney transplant, some people make new antibodies that target the donated organ and can lead to its failure. This trial tests whether rituximab, a drug that depletes B cells, can reduce those antibodies and help the kidney survive longer. Kidney transplant recipients who develop these antibodies are assigned to receive rituximab or a placebo, along with their usual immunosuppressive medicines. Researchers compare how antibody levels and kidney function change over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rituximab, a drug that depletes B cells
- What this could lead to
- If it works, rituximab could become a way to protect kidney transplants from antibody-driven damage and help them last longer.
- What could go wrong
- This is a Phase 2 study, so it cannot prove long-term benefit. Rituximab suppresses the immune system, which may raise the risk of infections, and not everyone may respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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757 people
The number who actually took part.
- Start date
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Mar 2006
- Finished
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Dec 2012
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis \[TB\] or atypical mycobacterial disease) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of study entry. Patients with fungal infections of nail beds are not excluded. * HIV infected * Surface antigen positive for hepatitis B virus (HBV) * Antibody positive for hepatitis C virus (HCV) * History of drug, alcohol, or chemical abuse within 6 months prior to study entry * History of cancer. Patients with adequately treated in situ cervical carcinoma or adequately treated basal or squamous cell carcinoma of the skin are not excluded. * Clinically significant cardiovascular or pulmonary disease * Evidence of urinary tract obstruction causing decreased kidney function, unless corrected by study entry * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would contraindicate use of an investigational drug, may affect interpretation of study results, or put the patient at high risk for treatment complications * History of psychiatric disorder that may interfere with participation in the study * History of nonadherence to prescribed regimens * Use of other investigational drugs within 4 weeks of study entry * Received any licensed or investigational live attenuated vaccine within 2 months of study entry. Stage 2 Exclusion Criteria for All Participants: * Previous treatment with rituximab * Immunoglobulin Levels \<500mg/dL (Combined IgM, IgG, IgA, IgE, IgD) * History of severe allergic reactions to monoclonal antibodies * History of cancer. Patients with adequately treated in situ cervical carcinoma or adequately treated basal or squamous cell carcinoma of the skin are not excluded. * Active systemic infection at the time of entry into Stage 2 * Recurrent or de novo glomerular disease or Banff Grade III chronic rejection other than chronic humoral rejection (CHR) indicated in baseline kidney biopsy post-transplant * History of post-transplant lymphoproliferative disease (PTLD) * Serum creatinine of 3.0 mg/dl or greater OR GFR less than 25 ml/min at the time of entry into Stage 2 * Hemoglobin less than 8.5 g/dl * Platelets less than 80,000 cells/mm\^3 * White blood cell count less than 3,000 cells/mm\^3 * AST or ALT 2.5 times the upper limit of normal at study entry * Pregnant or breast-feeding * Absolute neutrophil count less than 1000/mm\^3 Stage 2 Exclusion Criteria for Pediatric Participants (\<\\=18 Years of Age): * Positive test for parvovirus (B19) by PCR in the blood.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Children's Hospital Boston
Boston, Massachusetts, 02115, United States
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Children's Hospital and Regional Medical Center
Seattle, Washington, 98105, United States
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Legacy Transplant Services
Portland, Oregon, 97210, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Oregon Health Science University
Portland, Oregon, 97219, United States
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Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
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The Methodist Hospital
Houston, Texas, 77030, United States
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University of Alabama
Birmingham, Alabama, 35294, United States
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University of Alabama, Pediatric Nephrology
Birmingham, Alabama, 35294, United States
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University of California, San Francisco
San Francisco, California, 94143, United States
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University of Florida
Gainesville, Florida, 32601, United States
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University of Illinois
Chicago, Illinois, 60607, United States
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University of Maryland
Baltimore, Maryland, 21201, United States
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