Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT01873157
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
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).
Exclusion Criteria:
Part B (Interventional study)
* 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
* Thrombocytopenia \<30 G/l within 2 weeks before enrolment
* Neutrophil count \<1 G/l within 2 weeks before enrolment
* Peripheral neuropathy ≥grade 2
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01873157
Study Brief:
Protocol Section:
NCT01873157