Randomised Trial of Anti-CD20 in C4d+ Chronic Allograft Nephropathy - RituxiCAN-C4

King's College London0 个研究点目标入组 23 人开始时间: 2006年10月16日最近更新: 2019年6月30日

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•To be included in the study the patient must have:
•A functioning kidney allograft (with estimated GFR by MDRD >20) and be >6/12 post-transplantation
•Either deteriorating allograft function as defined by linear regression of reciprocal creatinine plot. Deterioration will be defined as a negative slope over at least the preceding 3 months (with at least 6 creatinines included) with an adjusted r2 >0.35 and a p value of =0.05 compared to horizontal baseline. Deterioration will be confirmed by Cockcroft Gault eGFR somparisons over same period to rule out body mass as a cause of change in creatinines
•OR Significant proteinuria defined as a urine protein : creatinine ratio =50
•OR Both deteriorating function and proteinuria
•CAN, by Banff ’97 criteria, or transplant glomerulopathy on renal allograft biopsy performed within 3/12 of enrolment
•Diffuse, linear C4d deposition on at least 25% of peritubular capillary (PTC) and/or glomerular EC of renal transplant biopsy when assessed by immunoperoxidase OR >50% of PTC (alone) when assessed by immunofluorescence.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•The presence of any of the following will preclude patient inclusion
•<18 years of age
•suspicion of pregnancy confirmed by positive HCG pregnancy test
•untreated ureteric obstruction on ultrasound of allograft
•history of acute allograft rejection in preceding 3/12
•history of MI in preceding 3/12
•history of malignancy in previous 5 years (excluding tumours limited to skin)
•symptomatic IHD
•recipient of simultaneous pancreas/kidney transplant
•recipient of ABO-incompatible kidney
•recipient who underwent an HLA desensitisation procedure prior to transplantation
•evidence, on examination of renal allograft biopsy specimen, of recurrent or de-novo disease (except IgA deposition in absence of mesangial proliferation)
•evidence, on examination of renal allograft biopsy specimen, of CNI toxicity IF ACCOMPANIED by mostly supra-therapeutic CNI trough levels in the 6 month period preceding biopsy.
•doumented allergy to mouse or chimeric human/mouse proteins
•HepBsAg+, HCV Ab+ or HIV+ or HepBcAb+
•administration of lymphocyte depleting antibody within 3 months of enrolment

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