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Randomised Trial of Anti-Cd20 in C4d+ Chronic Allograft Nephropathy

Phase 4
18 Years
70 Years
Open (Enrolling)
Kidney Transplantation, Graft Rejection, Immunosuppression

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Trial Information

Randomised Trial of Anti-Cd20 in C4d+ Chronic Allograft Nephropathy

Inclusion Criteria:

- Functioning kidney allograft (with estimated (e) GFR by MDRD >20) and be >6/12

- 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 reduction in Cockcroft-Gault (CG) eGFR over the same period (to exclude
increases in body mass as a cause of a negative slope on reciprocal creatinine plots)
OR significant proteinuria as assessed by a urine protein/creatinine ratio of ≥50

- CAN, by Banff '97 criteria, and/or transplant glomerulopathy on renal allograft
biopsy performed within 6/12 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

Exclusion Criteria:

- Ages below 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.

- Documented allergy to mouse or chimeric human/mouse proteins

- HepBsAg+, HepBcAb+, HCV Ab+ or HIV+.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of deterioration in renal function, defined by slope of reciprocal creatinine plot

Outcome Time Frame:

3-5 months post-randomisation

Safety Issue:


Principal Investigator

Anthony Dorling, PhD FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

King's College London


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

January 2007

Completion Date:

January 2016

Related Keywords:

  • Kidney Transplantation
  • Graft Rejection
  • Immunosuppression
  • chronic allograft nephropathy
  • C4d
  • Anti-CD20
  • B cells
  • Antibody