BridgeMD
INTERCEPT Study
EU CTIS ID: 2024-510615-29-00
What this study is testing
The primary objective of this study is to evaluate the efficacy of addition of TCZ to SOC as compared to SOC alone in slowing the decline of graft function from baseline at 24 months after start of treatment as assessed by estimated glomerular filtration rate (eGFR) in kidney transplant recipients with late/chronic active AMR.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subject has given their written informed consent to participate in the trial.
- Recipient of living donor or deceased donor kidney transplant
- Age ≥18 years
- At least 6 months post-transplantation at randomization
- Biopsy-proven diagnosis of late active (≥ 6 months posttransplant) or chronic active AMR according to the Banff 2022 criteria in index biopsy [Repeat biopsy and DSA-testing if required for diagnosis should be performed 2 months ± 2 weeks if the patient has received any treatment for AMR after the initial diagnostic biopsy or at randomization if the last biopsy is older than 12 months (+ 2 weeks) at randomization (Visit 2)].
- eGFR ≥20 ml/min/1.73 m2 (not older than 1 month at randomization).
You likely can't join if
- Recipient of multi-organ transplants
- Other significant liver disease as per Investigator’s opinion
- Neutropenia (<2 x109/L) or thrombocytopenia (<100 x109/L)
- 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 (IBD) or gastrointestinal perforation
See the full eligibility criteria
- The subject has given their written informed consent to participate in the trial.
- Recipient of living donor or deceased donor kidney transplant
- Age ≥18 years
- At least 6 months post-transplantation at randomization
- Biopsy-proven diagnosis of late active (≥ 6 months posttransplant) or chronic active AMR according to the Banff 2022 criteria in index biopsy [Repeat biopsy and DSA-testing if required for diagnosis should be performed 2 months ± 2 weeks if the patient has received any treatment for AMR after the initial diagnostic biopsy or at randomization if the last biopsy is older than 12 months (+ 2 weeks) at randomization (Visit 2)].
- eGFR ≥20 ml/min/1.73 m2 (not older than 1 month at randomization).
- EBV IgG-positive
- For female participants of childbearing potential: use of adequate contraception and a negative pregnancy test
- Subject known to have been previously had COVID-19 must meet the following conditions: • Asymptomatic for at least 1 month before screening visit • Re-established on background immunosuppressants for at least 1 month prior to randomization
- Recipient of multi-organ transplants
- Other significant liver disease as per Investigator’s opinion
- Neutropenia (<2 x109/L) or thrombocytopenia (<100 x109/L)
- 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 (IBD) or gastrointestinal perforation
- Ongoing 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 or reluctance that result in difficulties in 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 trial drug
- Woman with a positive pregnancy test or who is pregnant or breastfeeding
- De novo or recurrent renal disease, if it is considered to be the predominant cause of the current graft dysfunction
- Current or recent (within last 3 months) participation in another clinical drug trial
- Active viral infections such as BK virus (BKV), cytomegalovirus (CMV), SARS COV-2 (COVID-19), EBV, 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 serious infections requiring hospitalization
- Signs of post-transplant lymphoproliferative disorder
- Active tuberculosis (TB)
- Untreated 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.