This research study will assess the benefit of a novel immunosuppressive medication (Belatacept) in kidney transplant patients with proteinuria. Leaking protein in the urine (proteinuria) is a major risk factor for loosing a transplanted kidney (see figure below) and there are no clear therapy that has shown to reduce proteinuria and improve kidney survival in transplantation. B7-1 is a molecule that is potentially responsible for proteinuria in some patients and can be target by a new class of drugs in the market, which include Abatacept and Belatacept. Preliminary data is our laboratory indicates that B7-1 is expressed at significant levels in about 10% of kidney allograft biopsies with predominance in patients with proteinuria.
Our plan is to convert patients from Tacrolimus to Belatacept for 12 months and measure the reduction of proteinuria at 12 months. We will also monitor the kidney function, the appearance of anti-HLA antibodies, B7-1 markers in the urine, acute rejection and infections episodes. We plan to enroll 2 groups of patients: those that are B7-1 positive on biopsy and those that are B7-1 negative, since it is not clear if positivity on biopsy correlates with response to treatment.
Update December 2014: This trial is not enrolling yet. Enrollment is planned to start on March 2015.
Belatacept in Proteinuric