Status:
COMPLETED
Bortezomib in Late Antibody-mediated Kidney Transplant Rejection
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
Medical University Innsbruck
Conditions:
Late Rejection of Renal Transplant
Antibody-mediated Rejection
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Late antibody-mediated rejection (AMR) after kidney transplantation is defined as a separate rejection entity. So far, no appropriate treatment has been established for this rejection type. One promis...
Detailed Description
Background Recent studies have underscored a dominant role of alloimmune injury as a leading cause of long-term graft loss in kidney transplantation. In this respect, the formation of antibodies agai...
Eligibility Criteria
Inclusion
- Part A (Screening for DSA, cross-sectional)
- Written informed consent
- Age \> 18 years
- Functioning allograft after ≥180 days
- eGFR \>20 ml/min/1.73 m2
Exclusion
- Part A (Screening for DSA, cross-sectional)
- Patients actively participating in another clinical trial
- Female subject is pregnant or lactating
- Acute rejection treatment \<1 month before screening
- Acute deterioration of graft function due to suspected acute rejection
- Active viral, bacterial or fungal infection precluding bortezomib treatment
- Active malignant disease precluding intensified immunosuppressive therapy
- Serious medical or psychiatric illness likely to interfere with participation in the study
- Documented intolerance of Bortezomib, boron or mannitol
- Inclusion Criteria:
- Part B (Interventional study)
- Written informed consent
- Age \> 18 years
- Functioning allograft after ≥180 days
- eGFR \>20 ml/min/1.73 m2
- HLA class I and/or II DSA-positive
- A kidney biopsy result showing Glomerulitis and/or peritubular capillaritis and/or transplant glomerulopathy and/or peritubular capillary (PTC) basement membrane lamellation (with or without C4d in PTC).
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2017
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01873157
Start Date
December 1 2013
End Date
February 28 2017
Last Update
March 23 2017
Active Locations (1)
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1
Medical University of Vienna, Department of Nephrology and Dialysis
Vienna, Vienna, Austria, 1090