This study is being conducted to determine how safe and effective using an immune cell (b cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are experiencing certain types of rejection.
The purpose of the study is to determine safety and efficacy of treatment if mixed (cellular and antibody) mediated acute rejection with addition of B-cell depleting therapy to Thymoglobulin in kidney and simultaneous kidney pancreas allograft recipients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
The Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection
Rejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment. Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal.
Time frame: 1 year
Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy
Time frame: Day 1
Renal Allograft Survival
Time frame: 1 year after rejection treatment
Mean Serum Creatinine
Renal allograft function as determined by change (∆) in Calculated creatinine clearance by Cockcroft-Gault at 7, 14, 28, 60, and 90 days and 1 year post therapy initiation
Time frame: 7, 14, 28, 60, 90 days and 1 year post therapy initiation
Incidence of Death
Time frame: 90 days
Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy
Time frame: 90 days
Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patients will be premedicated with acetaminophen prior to dosing per institution standard of care.
Patients will be premedicated with an antihistamine prior to dosing per institution standard of care.
Methylprednisolone 250 mg with 1st dose of Thymoglobulin. Methylprednisolone 125 mg on treatment day 2 subsequent corticosteroids per institution standard of care; following treatment, corticosteroid therapy will resume at the pre-rejection dose.