A Phase 1/2 interventional study of donor specific transfusion and MMF, Bortezomib in Renal Transplantation and Uremia, sponsored by Fuzhou General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-08-22.
Sponsored by Fuzhou General Hospital · Phase 1/2, Interventional, and Treatment
The objective of this trial is to determine if clonal deletion before kidney transplantation can effectively reduce the need for post transplant immunosuppression. The investigators will adapt a DAWN (Drugs (immunosuppressants) Added When Needed) treatment protocol to assess the effect of clonal deletion and closely monitor acute rejection, renal function, and graft survival. 15 patients eligible for the study as described below will be enrolled.
The objective of this trial is to determine if clonal deletion can effectively reduce the need for post transplant immunosuppressive medicine. Emphasis will be placed on adverse events that are associated with clonal deletion. The investigators will assess whether DAWN (Drugs (immunosuppressants) Added When Needed) is feasible in living-relative donor kidney transplantation and the effectiveness of clonal deletion treatment on the rate of rejection, patient survival, and graft function from day 0 to 12 months after transplantation. Numbers of patients on single drug and dual therapy immunosuppression will be counted. Additionally, the investigators would assess time to immune event (rejection or antibody), the severity of acute rejection or antibody mediated rejection by Banff criteria, the incidence of delayed graft function (defined as the need for post-transplant dialysis), and the incidence of adverse events including infection, grade 3 and above non-hematologic toxicities, and grade 4 hematologic toxicities.
Exclusion Criteria:
Patient at risk for tuberculosis (TB) Current clinical, radiographic, or laboratory evidence of active or latent TB as determined by local standard of care
History of active TB:
Within the last 2 years, even if treated Greater than 2 years ago, unless there is documentation of adequate treatment according to locally accepted clinical practice Patient at risk of reactivation of TB precludes administration of conventional immunosuppression (as determined by investigator and based upon appropriate evaluation)
Subjects with uremia will undergo donor specific transfusion before transplantation
Procedure: donor specific transfusion
Drug: MMF, Bortezomib
Procedure: drugs added according to the immuno condition of the recipients
before transplantation,200mL of donor whole blood will be transfused to the recipient
MMF and Bortezomib will be administered after donor specific transfusion
drugs (corticosteroid, MMF and/or CNI) will be added according to the recipients immuno event and donor specific antibody
Dosage of immunosuppressants
Effectiveness of clonal deletion on reducing the dosage of immunosuppressants (calcineurin inhibitor plus mycophenolate, azothioprine, or sirolimus).
Time frame: one year
immune event
Time to immune event (acute rejection or DSA);
Time frame: 1 year
DSA
Proportion of patients who become positive for donor specific HLA antibodies post transplant
Time frame: 1 year
DGF
Incidence of delayed graft function (defined as need for post-transplant dialysis)
Time frame: 1 years
Renal function
Change in renal function as determined by estimated glomerular filtration rate and proteinuria (\>1g) at 1 year post transplant
Time frame: 1 year
Survival
Allograft Survival at 1 year post transplant
Time frame: 1 year
This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Fuzhou General Hospital