Randomised Trial of Rituximab in C4d+ Chronic Renal Transplant Rejectio

Phase 1

• Conditions: Renal Transplant Rejection - chronic; MedDRA version: 14.1 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2006-002330-38-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-16
• Study Completion: 2017-03-09
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 23

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified