Actively Recruiting
Led by Vastra Gotaland Region · Updated on 2025-04-03
50
Participants Needed
8
Research Sites
52 weeks
Total Duration
V
Vastra Gotaland Region
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
Researchers are evaluating the addition of the anti-IL-6 antibody tocilizumab (TCZ) to the standard treatment in kidney transplant recipients experiencing late or chronic antibody-mediated rejection (AMR). This randomized controlled open-label study aims to compare TCZ plus standard care against standard care alone in reducing the decline of kidney graft function. The trial involves 50 participants and is sponsored by Vastra Gotaland Region. Participants are assigned to one of two groups: one receiving standard care plus TCZ at 162 mg weekly by subcutaneous injection, and the other receiving standard care alone. The standard care includes oral tacrolimus, mycophenolic acid (MPA), and prednisolone. Treatment continues for 24 months, followed by a 12-month follow-up period. Kidney graft biopsies are performed at 12 and 24 months to monitor changes. During the study, participants will have their kidney function assessed through estimated glomerular filtration rate (eGFR) measurements and biopsies. Researchers will monitor changes in donor-specific antibodies, proteinuria, renal function, patient survival, and graft survival up to 36 months. Additional assessments include safety monitoring, symptom burden, medication adherence, and quality of life. The primary outcome is the change in eGFR from baseline to 24 months.
CONDITIONS
TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive either standard care alone or standard care plus weekly subcutaneous injections of tocilizumab.
Weekly visits for tocilizumab administration and monitoring; additional visits for standard care assessments as scheduled
Duration - Up to 12 months after treatment completion (up to 36 months total)
Participants are monitored for safety, kidney function, and other health outcomes after treatment ends.
Periodic visits for up to 12 months following treatment
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
S
Seema Baid-Agrawal, MD, FASN
M
Marie Felldin, MD, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lillian Streichart, Marie Felldin, Jana Ekberg...
https://pubmed.ncbi.nlm.nih.gov/38519988