A pilot, prospective, randomized, open-label, blinded endpoint (PROBE) histopathology trial to assess the effects of ACE- inhibition therapyin preventing the evolution of proliferative lesions assessed by renal biopsy in patients with extracapillary glomerulonephritis

Phase 1

• Conditions: Extracapillary glomerulonephritis; MedDRA version: 20.1Level: PTClassification code 10018376Term: Glomerulonephritis proliferativeSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2015-003884-12-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PAPA GIOVANNI XXIII

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 22

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),
- 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

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.

Study & Design

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