NCT04561986 TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
| NCT ID | NCT04561986 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vastra Gotaland Region |
| Condition | Antibody-mediated Rejection |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 50 participants in total. It began in 2022-02-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Seema Baid-Agrawal, MD, FASN
PRINCIPAL INVESTIGATOR
Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden
Frequently Asked Questions
Who can join the NCT04561986 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Antibody-mediated Rejection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04561986 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 50 participants.
Is NCT04561986 currently recruiting?
Yes, NCT04561986 is actively recruiting participants. Contact the research team at seema.baid-agrawal@vgregion.se for enrollment information.
Where is the NCT04561986 trial being conducted?
This trial is being conducted at A Coruña, Spain, Barcelona, Spain, Santander, Spain, Valencia, Spain and 4 additional locations.
Who is sponsoring the NCT04561986 clinical trial?
NCT04561986 is sponsored by Vastra Gotaland Region. The principal investigator is Seema Baid-Agrawal, MD, FASN at Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden. The trial plans to enroll 50 participants.