TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
NCT ID: NCT04561986
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
50 participants
INTERVENTIONAL
2022-02-01
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Longitudinal Changes in Donor-Derived Cell-Free DNA With Tocilizumab Treatment for Chronic Antibody-Mediated Rejection
NCT03859388
Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection
NCT01154387
Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab
NCT07006532
Treg Modulation With CD28 and IL-6 Receptor Antagonists
NCT04066114
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)
NCT04803058
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: Standard of care (SOC) + tocilizumab (TCZ)
SOC, as below + TCZ (162 mg every week, subcuataneous administration)
Tocilizumab
Tocilizumab is a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor
Arm B: SOC
Tacrolimus (target concentration 6 ±1 µg/L) + MPA (1.5-2 g/day as tolerated) + prednisolone (not less than 5 mg/day), all oral administration
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tocilizumab
Tocilizumab is a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karolinska University Hospital
OTHER
Uppsala University Hospital
OTHER
Skane University Hospital
OTHER
The Swedish Research Council
OTHER_GOV
Hospital del Mar
OTHER
Hospital Universitario Doctor Peset
OTHER
Complexo Hospitalario Universitario de A Coruña
OTHER
Hospital Universitario Marqués de Valdecilla
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Seema Baid-Agrawal
Associate Professor and Consultant Nephrologist, Transplantation Center, Sahlgrenska University Hospital, Gothenburg
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Seema Baid-Agrawal, MD, FASN
Role: PRINCIPAL_INVESTIGATOR
Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital del Mar
Barcelona, , Spain
Marqués de Valdecilla Research Institute
Santander, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Skåne University Hospital
Malmo, Skåne County, Sweden
Transplant Center, Sahlgrenska University Hospital
Gothenburg, Vastra Gotaland Regioin, Sweden
Karolinksa University Hospital
Stockholm, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Streichart L, Felldin M, Ekberg J, Mjornstedt L, Lindner P, Lennerling A, Brocker V, Molne J, Holgersson J, Daenen K, Wennberg L, Lorant T, Baid-Agrawal S. Tocilizumab in chronic active antibody-mediated rejection: rationale and protocol of an in-progress randomized controlled open-label multi-center trial (INTERCEPT study). Trials. 2024 Mar 22;25(1):213. doi: 10.1186/s13063-024-08020-0.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-510615-29-00
Identifier Type: CTIS
Identifier Source: secondary_id
2019-004302-10
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.