Rituximab
DrugIV rituximab
Other names: mabthera
NCT Number: NCT04033276
The objective of this study was to compare two strategies of de novo donor specific antibodies (DSA) and antibody-mediated rejection (AMR) prevention in renal transplant recipients: high dose intravenous immunoglobulin (IVIG)/rituximab regimens versus rituximab alone.
Looking for future studies?
Notify Me19 year and older
All sexes
Interventional
Phase 4
Seoul National University Hospital, Seoul, South Korea
Although recent advances in immunosuppressive regimens after kidney transplantation (KT) have reduced the incidence and consequences of T-cell-mediated rejection (TCMR) and have improved short-term outcomes, long-term allograft loss attributable to AMR is still responsible for substantial medical and socioeconomic burdens in kidney transplant recipients. Numerous studies have shown that de novo DSA after KT are associated with AMR, which leads to allograft loss. IVIG is a medication that has emerged as a useful tool in modulating immunity, treatment of AMR and in desensitization protocol. Treatment with rituximab or combination of IVIG/rituximab has sought to further diminish antibody production (de novo DSA) in the treatment of AMR. Several studies have been reported, but in the absence of control groups or standardization of treatment, their efficacy is difficult to assess.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All patients have de novo production of DR or DQ DSA after renal transplantation Inclusion criteria requires all of the following
Exclusion criteria
IV rituximab
Other names: mabthera
iv intravenous immune globulin
Other names: IVIG-SN
Time frame: baseline and 3 months post-treatment, 1 year post-treatment
change of pre- and post-treatment DSA MFI sum, monitoring DSA during follow-up period
Time frame: baseline and 3 months post-treatment, 1 year post-treatment
change of pre- and post-treatment eGFR by CKD-EPI equation, monitoring eGFR during follow-up period
Time frame: up to 1 year post-treatment
To identify the development of AMR after treatment during follow-up period
Seoul National University Hospital
Other
A Randomized, Open, Controlled Trial of High Dose IVIG/Rituximab Versus Rituximab in Kidney Transplant Patients With de Novo Donor-specific Antibodies
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03016455
Renal Transplant
Amiens, France
View Trial DetailsNCT02894606
Renal Transplant
Brest, France
View Trial DetailsNCT04838288
Renal Transplant
Nashville, Tennessee, United States
View Trial DetailsNCT04572854
C3 Glomerulonephritis, C3 Glomerulopathy
Phoenix, Arizona, United States
View Trial Details