Can a B-Cell drug stop antibodies from attacking a new kidney?

NCT ID NCT00307125

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

757 people

The number who actually took part.

Start date

Mar 2006

Finished

Dec 2012

Lead sponsor

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

5 to 70 years

Sex

Anyone

Healthy volunteers

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

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

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Boston

    Boston, Massachusetts, 02115, United States

  • Children's Hospital and Regional Medical Center

    Seattle, Washington, 98105, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Legacy Transplant Services

    Portland, Oregon, 97210, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health Science University

    Portland, Oregon, 97219, United States

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039, United States

  • The Methodist Hospital

    Houston, Texas, 77030, United States

  • University of Alabama

    Birmingham, Alabama, 35294, United States

  • University of Alabama, Pediatric Nephrology

    Birmingham, Alabama, 35294, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Florida

    Gainesville, Florida, 32601, United States

  • University of Illinois

    Chicago, Illinois, 60607, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

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