Clinical Trial: ACE-inhibitors in Extracapillary Glomerulonephritis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Extrac

Brief Summary: The natural course of extracapillary glomerulonephritis is severe leading to End-Stage Renal Disease (ESRD) or death in most cases. Despite immunosuppressive treatment, long-term renal outcome remains poor since active crescents usually progress to fibrotic scars with glomerular occlusion and disruption.In experimental models Angiotensin Converting Enzyme (ACE)-inhibitor therapy targeting the over-expression of angiotensin type 1 (AT1) receptors, that are responsible for dysregulated proliferation of parietal cell progenitors, blocks the formation of crescents and their fibrotic evolution. Should these drugs have similar effects in humans, ACE-inhibitor therapy on top of standard immunosuppression might be instrumental to prevent ESRD and promote renal function recovery in clinical practice.

Detailed Summary:
Sponsor: Monia Lorini

Current Primary Outcome: The extent of extracapillary proliferation on light microscopy, measured as % of total glomeruli with proliferative lesions at post-treatment repeat biopsy. [ Time Frame: Changes from baseline and 6 and 18 month. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Expression of parietal cell proliferation markers at glomerular level, graded on a scale of 0 to 3 (0: no staining, 1: mild, 2: moderate, 3: strong diffuse [ Time Frame: Changes from baseline and 6 and 18 month. ]
  • Number of fibrosclerotic crescents [ Time Frame: Changes from baseline and 6 and 18 month. ]
  • Glomerular Filtration Rate (GFR) measured by iohexol plasma clearance [ Time Frame: Changes from baseline and 6, 12 and 18 month. ]


Original Secondary Outcome: Same as current

Information By: A.O. Ospedale Papa Giovanni XXIII

Dates:
Date Received: February 10, 2016
Date Started: February 2016
Date Completion: December 2019
Last Updated: February 6, 2017
Last Verified: February 2017