Clinical Trial: Interest to Perform a Renal Biopsy Early in the Course of the Henoch-Schoenlein Nephritis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Interest to Perform a Renal Biopsy Early in the Course of the Henoch-Schoenlein Nephritis

Brief Summary:

Henoch-Schönlein (HS) purpura is a common cause of renal glomerular injury in children. This condition is responsible for 10-15% of glomerulonephritis in children. The outcome is generally favorable, but up to 5% of patients develop kidney failure. The outcome of patients with kidney biopsy is less favorable with 7-50% of them progressing to chronic renal failure.

Prevalence of HS is difficult to determine from literature. Annual incidence is estimated at 6.1 / 100,000 children in the Netherlands and up to 20.4 / 100 000 children in the United Kingdom. The proportion of children with HS who develop renal disease is difficult to determine because the numbers reported in the literature are variable and depend greatly on the type of the reporting center, whether or not specialized in pediatric nephrology. Thus the proportion of renal disease varies from 20% to 100% of children with a HS.

The treatment of HS nephropathy (HSN) usually depends on the severity of histological lesions but histological classification is discussed and there is currently no consensus. Randomized studies are scarce and often do not allow to draw clear conclusions. A meta-analysis suggested a positive effect of corticosteroids on renal prognosis of severe forms but in this study the definition of renal disease was very heterogeneous. The only classification of the HSN recognized is from the International Study Group of Kidney Disease in Childhood (ISKDC) which is the following: grade I: minimal glomerula abnormalities, grade II: pure proliferation, grade III: crescents/ segmental lesions <50%,grade IV: crescents/ segmental lesions 50 to 75%, grade V: crescents/ segmental lesions > 75%, grade VI: pseudomesangiocapillary. However, this classification is questioned because it ignores other significant histological lesions such as interstitial f

Detailed Summary:

If in the past the HSN could be considered a rather benign disease not requiring specific active treatment, the studies evaluating the long-term outcome have shown the risk of progression to Chronic Kidney Disease (CKD) and have lead to recommend the use of corticosteroids and immunosuppressors even in not rapidly progressive glomerulonephritis forms (24,25). Unfortunately clinical studies are scarce, often with few patients and uncontrolled (17,26,27). However, the efficacy of methylprednisolone pulses followed by oral steroids has been suggested in several studies, as in the study conducted at the Hospital Necker, where prospective patients receiving pulses of methylprednisolone were compared to an historical cohort from the same center (28) in a control arm of a randomized controlled trial (29), and in studies where patients received combinations of several immunosuppressive drugs (30-32).

Thus, the current French way to manage severe HSN is to give methylprednisolone pulses followed by oral steroids. Anti-proteinuric medications are for initially mild forms or sequelae. Immunosuppressor is added to steroid in the forms not responding well to initial corticosteroid therapy.

If these therapies are used by most of pediatric teams, practice in kidney biopsy (KB) varies from one center to another. Some teams routinely perform KB before the start of steroid therapy (and adapt the treatment to the results), while others first establish the treatment and perform the KB only if the evolution is not as expected. This second approach reduces the number of KB since patients with favorable outcome will never be biopsied.

The question is which of these two attitudes is the best. Do the biopsied patients have a better prognosis at 5 years (because the lesions were better evaluated in
Sponsor: CHU de Reims

Current Primary Outcome: clearance to creatinine [ Time Frame: between january 2006 and december 2010 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: CHU de Reims

Dates:
Date Received: June 21, 2016
Date Started: June 2016
Date Completion:
Last Updated: July 15, 2016
Last Verified: July 2016