TocIlizumab in Chronic Antibody-mediated Rejection in Kidney Transplant Recipients (INTERCEPT)

  • STATUS
    Recruiting
  • End date
    Dec 22, 2026
  • participants needed
    50
  • sponsor
    Vastra Gotaland Region
Updated on 22 March 2022

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 chronic antibody-mediated rejection (cAMR). 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 baseline, 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.

Details
Condition Antibody-mediated Rejection
Treatment Tocilizumab
Clinical Study IdentifierNCT04561986
SponsorVastra Gotaland Region
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The subject has given their written informed consent to participate in the study
Recipient of living donor or deceased donor kidney transplant
Age ≥18 years
At least 12 months post-transplantation at randomization
Biopsy-proven diagnosis of cAMR according to the Banff 2017 criteria in index biopsy
eGFR ≥20 ml/min/1.73 m2
Epstein-Barr Virus (EBV) IgG-positive
For female participants of childbearing potential
use of adequate contraception and a negative pregnancy test
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

Inability to tolerate any of the SOC treatment- tacrolimus, mycophenolate acid (MPA) or prednisolone
Recipient of multi-organ transplants
De novo or recurrent renal disease that, in the Investigator's opinion, could adversely influence the current allograft
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
Ongoing serious infections as per Investigator's opinion
History of recurrent infections requiring hospitalization
History of tuberculosis (TB)
Active TB or latent TB (positive QuantiFERON-TB-Gold test, Chest X-ray)
Abnormal liver function tests alanine transaminase (ALT), aspartate transaminase (AST), bilirubin > 1.5 x upper limit of normal)
Other significant liver disease as per Investigator's opinion
Neutropenia (<2 x109/L) or thrombocytopenia (<100 x109/L)
Signs of post-transplant lymphoproliferative disorder
Signs of malignancy. Exceptions are basal cell carcinoma/squamous cell carcinoma or non-malignant melanoma
History of malignancy, unless subject has been considered to have fully recovered from malignancy since > 2 years, without any signs of relapse
History of diverticulitis, inflammatory bowel disease or gastrointestinal perforation
Active alcohol or illicit substance abuse
Serious medical or psychiatric illness likely to interfere with participation in the study as per Investigator's opinion
Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
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
Woman with a positive pregnancy test or who is pregnant or breastfeeding
Current or recent (within last 3 months) participation in another clinical drug trial
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