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Clinical Trials in Spain / NCT04561986
Active, not recruiting Phase 3

TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

NCT04561986 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2022-02-01
Last updated
2026-08-10

Condition(s) studied

Antibody-mediated Rejection

Investigational drug(s) / intervention(s)

Tocilizumab →

Tocilizumab: Tocilizumab is a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor

Study summary

This multi-center study is an investigator-driven randomized controlled parallel group open-label clinical trial designed to evaluate the efficacy of addition of anti-IL-6 antibody tocilizumab (TCZ) to the standard of care (SOC) treatment as compared to the SOC alone in reducing the decline of graft function in kidney transplant recipients with late or chronic antibody-mediated rejection (AMR). A total of 50 recipients will be allocated to receive either TCZ (n=25) added to the standard of care (SOC) or SOC alone (n=25) for a period of 24 months. Patients will be followed for an additional 12 months. Protocol kidney graft biopsies will be performed at 12 and 24 months. The primary outcome is the mean rate of change in graft function as assessed by estimated glomerular filtration rate (eGFR) slope from baseline to 24 months after start of treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Complejo Hospitalario Universitario A Coruña A Coruña Spain
Hospital del Mar Barcelona Spain
Hospital Universitario Dr. Peset Valencia Spain
Karolinksa University Hospital Stockholm Stockholm County
Uppsala University Hospital Uppsala Uppsala County
Transplant Center, Sahlgrenska University Hospital Gothenburg Vastra Gotaland Regioin

On this site

📄 Actemra (tocilizumab) drug profile →

More Vastra Gotaland Region trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04561986 on ClinicalTrials.gov ↗ ← All trials in Spain