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New treatment option for Antibody-mediated Rejection
Official title TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT04561986
What this study is testing
What is Tocilizumab?
Tocilizumab is an investigational medicine, being studied as a potential treatment for antibody-mediated rejection.
Also referred to as RoActemra.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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 6 months post-transplantation at randomization
- Biopsy-proven diagnosis of late active or chronic active ABMR (≥ 6 months after transplantation) according to the Banff 2022 criteria in index biopsy
You likely can't join if
- Recipient of multi-organ transplants
- De novo or recurrent renal disease that is considered to be the predominant cause of the current graft dysfunction
- Active viral infections such as BK virus (BKV), cytomegalovirus (CMV), EBV, COVID-19, hepatitis C virus (HCV) or hepatitis B virus (HBV) infections...
- Ongoing serious infections as per Investigator's opinion
- History of recurrent infections requiring hospitalization
- Active tuberculosis (TB)
See the full eligibility 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 6 months post-transplantation at randomization
- Biopsy-proven diagnosis of late active or chronic active ABMR (≥ 6 months after transplantation) according to the Banff 2022 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
- Recipient of multi-organ transplants
- De novo or recurrent renal disease that is considered to be the predominant cause of the current graft dysfunction
- 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
- Active tuberculosis (TB)
- Latent untreatedTB (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
- 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 results 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 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
The study team makes the final eligibility decision.
Where it's taking place
- A Coruña, Spain
- Barcelona, Spain
- Santander, Spain
- Valencia, Spain
- Malmö, Skåne County, Sweden
- Gothenburg, Vastra Gotaland Regioin, Sweden
- Stockholm, Sweden
- Uppsala, Sweden
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 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include A Coruña, Spain; Barcelona, Spain; Santander, Spain; Valencia, Spain; Malmö, Skåne County, Sweden; Gothenburg, Vastra Gotaland Regioin, Sweden and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.