Ignite Creation Date:
2024-05-06 @ 8:33 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02765594
Status:
UNKNOWN
Last Update Posted:
2017-09-20
First Post:
2016-04-30
Brief Title:
Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathya Single Center Prospective Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2017-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HCQIgAN
Brief Summary:
Immunoglobulin A nephropathy IgAN is the most common primary glomerulonephritis in the worldThere is to date no curative therapy for patients with IgANIt is considered that dendritic cells Toll-like receptor TLR 9 and cytokines interleukin-6 IL-6 and interferon-alpha IFN-a and tumor necrosis factor-alpha TNF-α play an important role in the aberrant mucosal response Hydroxychloroquine is an antimalarial agent and had a notable impact on immune activation by the reduction of circulating activated immune cells that including decreased TLR-expressing cells reduced IFN-secreting plasmacytoid dendritic cells reduced production of inflammatory cytokines including interferon alpha IL-6 and TNF alpha Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard the onset of renal damage in patients with lupus nephritis hydroxychloroquine may have the potential effect in IgA nephropathy alleviated the proteinuria and had the renal protect effect This will be a single center prospective randomized controlled study to assess the utility of hydroxychloroquine in IgAN patients
Detailed Description:
Immunoglobulin A nephropathy IgAN is the most common primary glomerulonephritis in the world Its estimated frequency is at least 25 cases per year per 100000 adults The glomerulopathy usually progressed slowly leading to end stage renal disease ESRD ESRD developed in 20-40 of patients after 20 years Given its complex and as yet incompletely understood pathogenetic mechanisms there is to date no curative therapy for patients with IgAN
Although pathogenesis of IgAN is still obscure underglycosylated IgA-containing immune-complex including IgG or IgA antibodies against the hinge region of IgA1 are key factors for IgA nephropathy Aberrant mucosal immune response might lead to increased production of underglycosylated IgA1 It is considered that dendritic cells Toll-like receptor TLR9 and cytokines interleukin-6 IL-6 interferon-alpha IFN-a and tumor necrosis factor-alpha TNF-α play an important role in the aberrant mucosal response
Hydroxychloroquine is an antimalarial agent and had a notable impact on immune activation by the reduction of circulating activated immune cells that including decreased TLR-expressing cells reduced IFN-secreting plasmacytoid dendritic cells reduced production of inflammatory cytokines including interferon alpha IL-6 and TNF alpha Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard the onset of renal damage in patients with lupus nephritis
Therefore hydroxychloroquine targeting dendritic cells TLR IL-6 IFN-α and TNF-αmay have the potential effect in IgA nephropathy alleviated the proteinuria and had the renal protect effect This will be a single center prospective randomized controlled study to assess the utility of hydroxychloroquine added to valsartan in IgAN patients
Although pathogenesis of IgAN is still obscure underglycosylated IgA-containing immune-complex including IgG or IgA antibodies against the hinge region of IgA1 are key factors for IgA nephropathy Aberrant mucosal immune response might lead to increased production of underglycosylated IgA1 It is considered that dendritic cells Toll-like receptor TLR9 and cytokines interleukin-6 IL-6 interferon-alpha IFN-a and tumor necrosis factor-alpha TNF-α play an important role in the aberrant mucosal response
Hydroxychloroquine is an antimalarial agent and had a notable impact on immune activation by the reduction of circulating activated immune cells that including decreased TLR-expressing cells reduced IFN-secreting plasmacytoid dendritic cells reduced production of inflammatory cytokines including interferon alpha IL-6 and TNF alpha Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard the onset of renal damage in patients with lupus nephritis
Therefore hydroxychloroquine targeting dendritic cells TLR IL-6 IFN-α and TNF-αmay have the potential effect in IgA nephropathy alleviated the proteinuria and had the renal protect effect This will be a single center prospective randomized controlled study to assess the utility of hydroxychloroquine added to valsartan in IgAN patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None