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New treatment option for Glomerulonephritis
Official title Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.
ClinicalTrials.gov ID: NCT04662723
What this study is testing
What is Corticosteroid?
Corticosteroid is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for glomerulonephritis.
Also referred to as Methylprednisolone succinate, prednisolone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Idiopathic immunoglobulin A nephropathy (IgAN) is the most common biopsy-proven glomerulonephritis in the world. Approximately 40% of IgAN patients reach end-stage kidney disease (ESKD) 20 years after their kidney biopsy.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Only adult patients (age 18-70 years) with biopsy-proven idiopathic IgAN.
- IgAN patients with active or chronic or moderate renal lesions
You likely can't join if
- Patients with idiopathic IgAN and nephrotic syndrome (minimal change disease at kidney biopsy)
- IgAN patients with hematuria and acute renal failure
- IgAN patients with rapidly progressive glomerulonephritis (extracapillary lesions in more than 50% of glomeruli)
- Patients with secondary IgAN (lupus nephritis, Schoenlein-Henoch purpura, liver cirrhosis)
- Any prior immunosuppressive therapy
- Superimposed IgAN in kidney transplant
See the full eligibility criteria
- Only adult patients (age 18-70 years) with biopsy-proven idiopathic IgAN.
- IgAN patients with active or chronic or moderate renal lesions
- Patients with idiopathic IgAN and nephrotic syndrome (minimal change disease at kidney biopsy)
- IgAN patients with hematuria and acute renal failure
- IgAN patients with rapidly progressive glomerulonephritis (extracapillary lesions in more than 50% of glomeruli)
- Patients with secondary IgAN (lupus nephritis, Schoenlein-Henoch purpura, liver cirrhosis)
- Any prior immunosuppressive therapy
- Superimposed IgAN in kidney transplant
- Severe liver diseases
- Infections
- Malignancies
- Pregnancy
- Patients with myocardial infarction or cerebrovascular stroke in the previous 6 months
- Uncontrolled diabetes
- Aseptic necrosis of any bone
- Other conditions that can be exacerbated by corticosteroids
- Previous adverse side effects to RASBs
- Previous adverse side effects to SGLT2is
- Patients with mild renal lesions (M0,E0,S0,T0,C0), minor urinary findings, proteinuria \< 0.5 g/day, normal GFR and normal blood pressure
The study team makes the final eligibility decision.
Where it's taking place
- Bari, BA, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bari, BA, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.