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 个研究点目标入组 22 人开始时间: 2021年1月28日最近更新: 2021年4月5日

试验速览

暂无简介。

•- 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),
•- Primary or secondary membranous nephropathy (MN),
•- Primary or idhiopatic immune complex glomerulonephritis.
•- Clinical indication to immunosuppressive therapy;
•- No specific indication to treatment with RAS inhibitors such as heart failure or coronary ischemic disease;
•- Written informed consent.
•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 11
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 11

•- 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.

发起方

AZIENDA OSPEDALIERA PAPA GIOVANNI XXIII