NCT01408797

Clonal Deletion on Living-Relative Donor Kidney Transplantation

A Prospective, Open-Label, Pilot Study of Clonal Deletion on Living-Relative Donor Kidney Transplantation

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Fuzhou General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Renal Transplantation
• Uremia

Interventions

Type	Name	Description
PROCEDURE	donor specific transfusion	before transplantation,200mL of donor whole blood will be transfused to the recipient
DRUG	MMF, Bortezomib	MMF and Bortezomib will be administered after donor specific transfusion
PROCEDURE	drugs added according to the immuno condition of the recipients	drugs (corticosteroid, MMF and/or CNI) will be added according to the recipients immuno event and donor specific antibody

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-08-03
• Last updated: 2011-08-22

Locations

1 site across 1 country: China