Can a new drug combo save failing kidney transplants?
NCT ID NCT04561986
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether adding tocilizumab to standard care can slow the decline in kidney function for people who have chronic antibody-mediated rejection after a kidney transplant. Half of the 50 participants will receive tocilizumab plus standard care, while the other half receives standard care alone, for 24 months. The main goal is to compare the change in kidney function (measured by eGFR) between the two groups over that period. Participants will also have kidney biopsies at 12 and 24 months to monitor the rejection process.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tocilizumab (also known as RoActemra), a drug that blocks the IL-6 receptor to dampen the immune attack on the transplanted kidney.
- What this could lead to
- If effective, adding tocilizumab to standard care could slow the loss of kidney function in transplant recipients with chronic rejection, potentially delaying or avoiding the need for dialysis or a new transplant.
- What could go wrong
- This is a relatively small trial (50 participants), and results may not apply to all patients. Tocilizumab can increase the risk of infections and other side effects, and the benefit over standard care alone is not yet proven.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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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18 to 100 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The subject has given their written informed consent to participate in the study 2. Recipient of living donor or deceased donor kidney transplant 3. Age ≥18 years 4. At least 6 months post-transplantation at randomization 5. Biopsy-proven diagnosis of late active or chronic active ABMR (≥ 6 months after transplantation) according to the Banff 2022 criteria in index biopsy 6. eGFR ≥20 ml/min/1.73 m2 7. Epstein-Barr Virus (EBV) IgG-positive 8. For female participants of childbearing potential: * use of adequate contraception and a negative pregnancy test 9. Subject known to have COVID-19 previously must meet all of the following conditions: * Asymptomatic for at least 1 month before the start of screening * Re-established on background immunosuppressants for at least 1 month prior to the randomization Exclusion Criteria: 1. Recipient of multi-organ transplants 2. De novo or recurrent renal disease that is considered to be the predominant cause of the current graft dysfunction 3. Active viral infections such as BK virus (BKV), cytomegalovirus (CMV), EBV, COVID-19, hepatitis C virus (HCV) or hepatitis B virus (HBV) infections based on polymerase chain reaction (PCR) testing 4. Ongoing serious infections as per Investigator's opinion 5. History of recurrent infections requiring hospitalization 6. Active tuberculosis (TB) 7. Latent untreatedTB (positive QuantiFERON-TB-Gold test, Chest X-ray) 8. Abnormal liver function tests alanine transaminase (ALT), aspartate transaminase (AST), bilirubin \> 1.5 x upper limit of normal) 9. Other significant liver disease as per Investigator's opinion 10. Neutropenia (\<2 x109/L) or thrombocytopenia (\<100 x109/L) 11. Signs of post-transplant lymphoproliferative disorder 12. Signs of malignancy. Exceptions are basal cell carcinoma/squamous cell carcinoma or non-malignant melanoma 13. History of malignancy, unless subject has been considered to have fully recovered from malignancy since \> 2 years, without any signs of relapse 14. History of diverticulitis, inflammatory bowel disease or gastrointestinal perforation 15. Ongoing alcohol or illicit substance abuse 16. Serious medical or psychiatric illness likely to interfere with participation in the study as per Investigator's opinion 17. Mental inability or reluctance that results in difficulties in understanding the meaning of study participation 18. Woman of childbearing potential who is unwilling/unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug 19. Woman with a positive pregnancy test or who is pregnant or breastfeeding 20. Current or recent (within last 3 months) participation in another clinical drug trial
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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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Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
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Hospital Universitario Dr. Peset
Valencia, Spain
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Hospital del Mar
Barcelona, Spain
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Karolinksa University Hospital
Stockholm, Stockholm County, SE-141 86, Sweden
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Transplant Center, Sahlgrenska University Hospital
Gothenburg, Vastra Gotaland Regioin, Sweden
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Uppsala University Hospital
Uppsala, Uppsala County, 751 85, Sweden
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new infusion stop the Body's attack on a transplanted kidney?
- New Two-Step therapy aims to stop chronic kidney transplant rejection
- Gene expression platform could revolutionize kidney transplant rejection diagnosis
- New drug aims to stop kidney transplant rejection
- New hope for kidney transplant patients: extended drug trial targets rejection
- Gene clues may explain why light therapy helps some transplant patients