Actively Recruiting
TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
Led by Vastra Gotaland Region · Updated on 2025-04-03
50
Participants Needed
8
Research Sites
356 weeks
Total Duration
On this page
Sponsors
V
Vastra Gotaland Region
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent to participate
- Recipient of living or deceased donor kidney transplant
- Age 18 years or older
- At least 6 months after kidney transplant at the time of randomization
- Biopsy-proven late active or chronic active antibody-mediated rejection diagnosed at least 6 months after transplantation using Banff 2022 criteria
- Estimated glomerular filtration rate (eGFR) of 20 ml/min/1.73 m2 or higher
- Positive Epstein-Barr Virus (EBV) IgG test
- For women of childbearing potential, use of effective contraception and a negative pregnancy test
- If previously had COVID-19, must have been symptom-free for at least 1 month before screening and re-established on immunosuppressants for at least 1 month before randomization
You will not qualify if you...
- Recipient of multi-organ transplants
- Presence of new or recurring kidney disease that is the main cause of current graft problems
- Active infections with BK virus, cytomegalovirus, Epstein-Barr virus, COVID-19, hepatitis B or C based on PCR testing
- Ongoing serious infections as judged by the investigator
- History of repeated infections requiring hospitalization
- Active or untreated latent tuberculosis
- Abnormal liver function tests (ALT, AST, bilirubin over 1.5 times normal)
- Other significant liver diseases as judged by the investigator
- Low neutrophil count (<2 x109/L) or low platelet count (<100 x109/L)
- Signs of post-transplant lymphoproliferative disorder or malignancy (except certain skin cancers)
- History of cancer unless fully recovered for over 2 years without relapse
- History of diverticulitis, inflammatory bowel disease, or gastrointestinal perforation
- Ongoing alcohol or substance abuse
- Serious medical or psychiatric conditions interfering with study participation
- Mental inability or reluctance to understand study participation
- Women unwilling or unable to use contraception throughout the study and up to 8 weeks after last dose
- Pregnant or breastfeeding women
- Participation in another drug trial within the last 3 months
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Not Yet Recruiting
2
Hospital del Mar
Barcelona, Spain
Active, Not Recruiting
3
Marqués de Valdecilla Research Institute
Santander, Spain
Not Yet Recruiting
4
Hospital Universitario Dr. Peset
Valencia, Spain
Not Yet Recruiting
5
Skåne University Hospital
Malmö, Skåne County, Sweden, 214 28
Actively Recruiting
6
Transplant Center, Sahlgrenska University Hospital
Gothenburg, Vastra Gotaland Regioin, Sweden
Actively Recruiting
7
Karolinksa University Hospital
Stockholm, Sweden, SE-141 86
Actively Recruiting
8
Uppsala University Hospital
Uppsala, Sweden, 751 85
Actively Recruiting
Research Team
S
Seema Baid-Agrawal, MD, FASN
CONTACT
M
Marie Felldin, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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