EUCTR2015-003884-12-IT
Active, not recruiting
Phase 1
A pilot, prospective, randomized, open-label, blinded endpoint (PROBE) histopathology trial to assess the effects of ACE- inhibition therapy on glomerular proliferative lesions in patients with extracapillary glomerulonephritis - ACE-inhibitors in extracapillary glomerulonephritis
AZIENDA OSPEDALIERA PAPA GIOVANNI XXIII0 sites22 target enrollmentJanuary 28, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AZIENDA OSPEDALIERA PAPA GIOVANNI XXIII
- Enrollment
- 22
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Males and females;
- •\- Adult age (\>18 years old);
- •\- Rapidly progressive renal failure associated with acute nephritic syndrome and/or nephrotic syndrome;
- •\- Histology evidence of extracapillary proliferation with less than 50% of sclerotic glomeruli and associated with:
- •Type I: Anti\-Glomerular Basement Membrane (GBM) antibody glomerulonephritis,
- •Type II: Pauci\-immune vasculitis or Anti Neutrophil Cytoplasmic Antibody (ANCA) associated vasculitis;
- •Type III: Immune\-complex mediated glomerular diseases:
- •\- Proliferative lupus nephritis (LN),
- •\- IgA nephropathy (IgAN)/ Schönlein\-Henoch purpura,
- •\- Type I membranoproliferative glomerulonephropathy (MPGN),
Exclusion Criteria
- •\- Pre\-existing advanced chronic renal failure (creatinine clearance less than 20 ml/min/1\.73m2\);
- •\- Evidence of B or C virus active infection;
- •\- HIV infection;
- •\- Recent diagnosis of malignancy;
- •\- Prolonged bleeding time and any other contraindication to kidney biopsy evaluation;
- •\- Any specific contraindication to ACE inhibitor therapy (that is: history of angioedema a or other treatment\-related serious adverse events);
- •\- Pregnancy or lactating;
- •\- Women of childbearing potential without following a scientifically accepted form of contraception;
- •\- Inability to understand the risks and benefit of the study or evidence of an uncooperative attitude;
- •\- Legal incapacity.
Outcomes
Primary Outcomes
Not specified
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