Condition: Antibody-mediated Rejection · Sponsor: Vastra Gotaland Region
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.
This description comes directly from the study's public registry record.
Seema Baid-Agrawal, MD, FASN · +4631-342 10 00 · seema.baid-agrawal@vgregion.se
Marie Felldin, MD, PhD · +4631-342 10 00 · marie.felldin@surgery.gu.se
Always discuss trial participation with your own doctor first.
| Complejo Hospitalario Universitario A Coruña | A Coruña, Spain | Not Yet Recruiting |
| Hospital del Mar | Barcelona, Spain | Active Not Recruiting |
| Marqués de Valdecilla Research Institute | Santander, Spain | Not Yet Recruiting |
| Hospital Universitario Dr. Peset | Valencia, Spain | Not Yet Recruiting |
| Skåne University Hospital | Malmö, Skåne County, Sweden | Recruiting |
| Transplant Center, Sahlgrenska University Hospital | Gothenburg, Vastra Gotaland Regioin, Sweden | Recruiting |
| Karolinksa University Hospital | Stockholm, Sweden | Recruiting |
| Uppsala University Hospital | Uppsala, Sweden | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04561986