IgA Nephropathy Clinical Trial
Official title:
Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA)Nephropathy Course QUIgAN Study
immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity. In this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus Erythematosus) and very low priced. One randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group). Considering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05016323 -
A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.
|
Phase 2 | |
| Withdrawn |
NCT02433236 -
Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy
|
Phase 2 | |
| Recruiting |
NCT02231125 -
Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy
|
Phase 4 | |
| Completed |
NCT01502579 -
An Observational Study of IgA Nephropathy: Pathological Variants and Clinical Data
|
N/A | |
| Not yet recruiting |
NCT01203007 -
Diet Intervention in Food Sensitive Patients With IgA Nephropathy
|
N/A | |
| Terminated |
NCT01129557 -
Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease
|
Phase 4 | |
| Completed |
NCT00657059 -
Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)
|
Phase 3 | |
| Recruiting |
NCT04684745 -
Open-Label Extension Study of BION-1301 in IgA Nephropathy
|
Phase 2 | |
| Completed |
NCT03719443 -
First in Human Study to Assess Safety of VIS649 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02112838 -
Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
|
Phase 2 | |
| Withdrawn |
NCT02052219 -
BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
|
Phase 3 | |
| Completed |
NCT00767221 -
Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study
|
Phase 2 | |
| Recruiting |
NCT04438603 -
The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
|
||
| Recruiting |
NCT06065852 -
National Registry of Rare Kidney Diseases
|
||
| Terminated |
NCT04905212 -
A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
|
Phase 2 | |
| Terminated |
NCT04042623 -
Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy
|
Phase 2 | |
| Recruiting |
NCT03633864 -
Fecal Microbiota Transplantation for Refractory IgA Nephropathy
|
Phase 2 | |
| Not yet recruiting |
NCT06454110 -
Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)
|
Phase 2 | |
| Recruiting |
NCT02954419 -
IgA Nephropathy Biomarkers Evaluation Study (INTEREST)
|
||
| Recruiting |
NCT03001947 -
IgA Nephropathy Registration Initiative of High Quality (INSIGHT)
|