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Table 4 Study endpoints

From: Bortezomib in late antibody-mediated kidney transplant rejection (BORTEJECT Study): study protocol for a randomized controlled trial

Primary outcome

Slope of eGFR over 24 months

Secondary outcomes

Graft and patient survival at 24 months

 

Measured GFR (Cr-51-EDTA method) at 24 months

 

DSA at 6, 12, 18, and 24 months

 

 Mean fluorescence intensity levels

 

 Number of human leukocyte antigen specificities

 

Urinary protein excretion (protein/creatinine ratio) at 6, 12, 18, and 24 months

 

Occurrence of biopsy-proven acute rejection necessitating rejection treatment

 

Acute AMR score in a protocol biopsy performed at 24 months

 

Chronic AMR score in a protocol biopsy performed 24 months

  1. AMR, antibody-mediated rejection; Cr-51-EDTA, chromium ethylenediamine tetraacetic acid; DSA, donor-specific antibodies; eGFR, estimated glomerular filtration rate; GFR, glomerular filtration rate.