Bortezomib for the treatment of late transplant rejection after kidney transplantatio

Phase 1

• Conditions: ate antibody-mediated kidney allograft rejection; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-002857-41-AT
• Lead Sponsor: niversitätsklinik für Innere Medizin III, Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-18
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Voluntary written informed consent
Age >18 years
Functioning allograft after =180 days
eGFR >20 ml/min/1.73 m2
Serological results
HLA class I and/or II DSA-positive
Index BX results
At least one of the following features (with or without C4d in PTC):
Glomerulitis – PTCitis - transplant glomerulopathy - PTC BM lamellation

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 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Laboratory tests
Thrombocytopenia <30 G/l within 2 weeks before enrolment
Neutrophil count <1 G/l within 2 weeks before enrolment
Clinical evaluation
Peripheral neuropathy =grade 2
Index BX results
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
T-cell-mediated rejection classified Banff grade >I
De novo or recurrent severe thrombotic microangiopathy
Polyoma virus nephropathy
De novo or recurrent glomerulonephritis in the allograft

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the planned non-commercial investigator-initiated and -driven study is to assess the efficiency of the innovative concept of proteasome inhibition in the treatment of late AMR. Our primary hypothesis is that, by inhibiting alloantibody production bortezomib halts the progression of ongoing graft injury and dysfunction.;Secondary Objective: not applicable;Primary end point(s): Course of calculated GFR over 2 years (0, 6, 12, 18, 24 months);Timepoint(s) of evaluation of this end point: 0, 6, 12, 18, 24 months after randomization