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Can a new drug combo save failing kidney transplants?

NCT ID NCT04561986

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 100 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: 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

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, Spain

  • Hospital Universitario Dr. Peset

    Valencia, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Karolinksa University Hospital

    Stockholm, Stockholm County, SE-141 86, Sweden

  • Transplant Center, Sahlgrenska University Hospital

    Gothenburg, Vastra Gotaland Regioin, Sweden

  • Uppsala University Hospital

    Uppsala, Uppsala County, 751 85, Sweden

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