Can a Two-Pronged immune attack stop kidney transplant rejection?

NCT ID NCT04066114

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Researchers are testing whether a combination of drugs, including lulizumab pegol and tocilizumab, can safely prevent organ rejection in people who receive a kidney from a living donor. The study also uses standard anti-rejection medicines like rabbit antithymocyte globulin, methylprednisolone, belatacept, and everolimus. The goal is to see if this approach keeps participants free of rejection for at least six months after transplant. The trial enrolls 24 adults and is in early phases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lulizumab pegol, an experimental biologic that blocks a specific immune signal called CD28
What this could lead to
If it works, this approach could offer kidney transplant recipients a way to prevent rejection while using less of the standard anti-rejection drug tacrolimus, which can harm the kidneys over time.
What could go wrong
This is a small, early-stage trial with only 24 participants, so safety and effectiveness are still unknown. The drug combination could cause infections or other side effects, and the results may not apply to all transplant patients.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

24 people

The number who actually took part.

Started

Dec 2019

Finished

Sep 2023

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

18 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.

Inclusion Criteria: Individuals who meet all the following criteria are eligible for enrollment as study participants: 1. Able to understand and provide informed consent 2. Agreement to use highly effective (\<1% failure rate) methods of contraception: Women of Childbearing Potential (WOCBP)- * Progestogen only hormonal contraception associated with inhibition of ovulation, * Hormonal methods of contraception including oral contraceptive pills containing a combination of estrogen + progesterone, vagina ring, injectables, implants and intrauterine devices (IUDs), * Non-hormonal IUDs, * Bilateral tubal occlusion, * Vasectomized partner, * Intrauterine hormone-releasing system (IUS), or * Complete abstinence. Note: Female participants of childbearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for 12 months while on study drug regimen. Male Participants- --Must use a latex or other synthetic condom during any sexual activity with WOCBP until one month after the last dose of lulizumab (e.g., up to 3.5 months in duration). 3. Recipient of primary, nonhuman leukocyte antigen identical living donor kidney transplant 4. No donor specific antibodies prior to transplant that are considered to be of clinical significance by the site investigator 5. Epstein-Barr virus (EBV) positive serology 6. Cytomegalovirus (CMV) positive serology, unless donor-recipient pair are both CMV negative 7. Negative testing for latent Tuberculosis (TB) infection within 3 months prior to transplant * Testing should be conducted using either a purified protein derivative (PPD) or an interferon-gamma release assay blood test for TB (i.e. QuantiFERON®-TB Gold in-Tube test or T-SPOT® TB test) * Subjects with a positive test for latent TB infection must complete appropriate therapy for Latent tuberculosis infection (LTBI). ---A subject is considered eligible only if they have a negative test for LTBI within 3 months prior to transplant or, they have appropriately completed LTBI therapy prior to transplant. Note: Latent TB infection treatment regimens should be among those endorsed by the CDC (Division of TB Elimination, 2016). 8. In the absence of contraindication, vaccinations must be up to date for hepatitis B, influenza, pneumococcal, varicella and herpes zoster, and measles, mumps, and rubella (MMR) 9. Hepatitis C Virus (HCV) antibody positive subjects with negative HCV by PCR testing are eligible if they: * have spontaneously cleared infection, or * are in sustained virologic remission for at least 12 weeks after treatment for HCV. 10. Negative SARS-CoV-2 PCR test result performed within 2 weeks of transplant (SARS-CoV-2 is the virus that causes COVID-19) Exclusion Criteria: Individuals who meet any of these criteria are not eligible for enrollment as study participants- 1. Prisoners or subjects who are compulsorily detained 2. Inability or unwillingness of a participant to give written informed consent or comply with study protocol 3. Candidate for a multiple solid organ or tissue transplants 4. Prior history of organ or cellular transplantation 5. Known to have idiopathic focal segmental glomerulosclerosis (FSGS) as the underlying cause of kidney failure (ESRD) 6. Requirement for uninterrupted anticoagulation therapy, including Plavix. 7. Known hypersensitivity to mechanistic target of rapamycin (mTOR) inhibitors or contraindication to everolimus (including history of wound healing complications) 8. History of severe allergic and/or anaphylactic reactions to humanized or murine monoclonal antibodies 9. Hypersensitivity to rabbit proteins or rabbit anti-thymocyte Globulin (ATG) 10. Known hypersensitivity to ACTEMRA® (tocilizumab) or lulizumab pegol (BMS-931699) 11. The human immunodeficiency virus (HIV) infected subjects, including those who are well controlled on antiretrovirals 12. Positive hepatitis B surface antigen (HBSAg), or hepatitis B core antibody (HBcAB) serology 13. Hepatitis C virus antibody positive (HCV Ab+) subjects who have failed to demonstrate sustained viral remission for more than 12 weeks after anti-viral treatment 14. Subjects with a previous history of active Tuberculosis (TB) 15. Known active current viral, fungal, mycobacterial or other infections (including, but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster) 16. Donor or recipient residing in areas where the annual incidence ≥ 21 cases per 100,000) for coccidioidomycosis according to current CDC map: (https://www.cdc.gov/fungal/diseases/coccidioidomycosis/causes.html) * Donors or recipients residing in low risk zones (annual \<21 cases per 100,000) will not require additional screening 17. History of malignancy except treated basal cell cancer of the skin 18. History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura 19. History of demyelinating disorders (e.g., multiple sclerosis, chronic inflammation demyelinating polyneuropathy) 20. History of gastrointestinal perforations, active inflammatory bowel disease or diverticulitis 21. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation 22. Receipt of a live vaccine within 30 days prior to transplantation. 23. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may: * pose additional risks from participation in the study, * may interfere with the participant's ability to comply with study requirements, or * that may impact the quality or interpretation of the data obtained from the study 24. Severe hyperlipidemia (defined by total cholesterol \>350 mg/dL, LDL \>190 mg/dL, or triglycerides \>500 mg/dL) 25. Transaminase levels elevated more than 1.5 times the upper limit of normal (ULN) within 7 days prior to enrollment 26. The absolute neutrophil count (ANC) \< 2,000 per mm\^3 within 7 days prior to enrollment 27. Platelet count less than 100,000 per mm\^3 within 7 days prior to enrollment 28. More than 50% CD8+/ CD28- T-cells in peripheral blood 29. A calculated panel reactive antibody (cPRA) ≥20%, as determined by each participating site's laboratory 30. Positive pregnancy test in women of child bearing potential, currently breastfeeding, or planning to become pregnant during the timeframe of the study or follow-up period 31. Participation in any other studies with investigational drugs or regimens in the preceding year

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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

  • Cleveland Clinic Foundation: Transplantation

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center: Transplantation

    Durham, North Carolina, 27710, United States

  • Northwestern Memorial Hospital: Transplantation

    Chicago, Illinois, 60611, United States

  • University of Alabama School of Medicine: Transplantation

    Birmingham, Alabama, 35233, United States

  • University of California San Francisco School of Medicine: Transplantation

    San Francisco, California, 94143, United States

  • University of Colorado (UC) Health Transplant Center - Anschutz

    Aurora, Colorado, 80045, United States

  • University of Nebraska Medical Center: Transplantation

    Omaha, Nebraska, 68105, United States

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