Sparsentan for IgA Vasculitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Travere Investigational Site, Nijmegen, Netherlands
IgA Vasculitis+10 More
Sparsentan - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether sparsentan is safe and effective for treating proteinuria in people with kidney disease.

See full description

Eligible Conditions

  • IgA Vasculitis
  • Immunoglobulin A-Associated Vasculitis
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Immunoglobulin A Nephropathy
  • Nephrotic Syndrome
  • Alport Syndrome

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Sparsentan will improve 2 primary outcomes and 10 secondary outcomes in patients with IgA Vasculitis. Measurement will happen over the course of Week 108 post-treatment.

Week 108
Urine protein/creatinine ratio (UP/C) at week 108
Week 108
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of interest (AEOIs)
Week 12
Observed plasma Pharmacokinetic (PK) concentrations
Week 108
Proportion of subjects with FSGS and/or MCD histological patterns achieving partial remission
Steady-state PK parameters [Cmax_ss]
Steady-state PK parameters [Cmin_ss]
Steady-state PK parameters area under the plasma concentration-time curve during a dosing interval ([AUCτ])
Week 108 post-treatment
Urine albumin/creatinine ratio (UA/C) over the 108 week
eGFR over the 108-week period
Week 112
Estimated glomerular filtration rate (eGFR) over the 112 weeks
Urine albumin/creatinine ratio (UA/C) over the 112 weeks
Urine protein/creatinine ratio (UP/C) over the 112 weeks

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Population 2: IgAN, IgAV, or AS
1 of 2
Population 1: FSGS and/or MCD
1 of 2
Experimental Treatment

This trial requires 57 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sparsentan is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Population 2: IgAN, IgAV, or AS
Drug
Subjects with biopsy-confirmed immunoglobulin A nephropathy (IgAN), immunoglobulin A vasculitis (IgAV), or subjects with Alport syndrome (AS)
Population 1: FSGS and/or MCD
Drug
Subjects with selected proteinuric glomerular diseases associated with FSGS and MCD histological patterns

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after the last patient has undergone the week 108 visit (visit 15)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly after the last patient has undergone the week 108 visit (visit 15) for reporting.

Closest Location

Travere Investigational Site - New Hyde Park, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subject or parent/legal guardian (as appropriate) is willing and able to provide signed informed consent/assent, and where required, the subject is willing to provide assent before any screening procedures per local requirements.
You have an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1. show original
You are male or female ≥1 year at screening and <18 years of age at Day 1 (Baseline). show original
Kidney biopsy-proven FSGS or MCD histological patterns and clinical presentation consistent with primary FSGS or MCD and qualifying proteinuria at screening despite history or ongoing treatment with corticosteroids and/or other immunosuppressive disease-modifying agents.
Kidney biopsy-proven FSGS histological pattern with medical history and clinical presentation consistent with maladaptive cause of the lesion.
You have a kidney biopsy performed that includes light microscopy and electron microscopy characteristics and/or immunofluorescence findings consistent with FSGS or MCD. show original
You are at least 2 years old and less than 18 years old. show original
Kidney biopsy-confirmed IgAN, IgAV, or AS
You have a mean seated blood pressure between the 5th and 95th percentile for sex and height. show original
Subjects with a documented podocytic mutation do not require kidney biopsy. show original

Patient Q&A Section

What causes hyalinosis, segmental glomerular?

"In our practice, hypertensive glomerulopathy is not found in any patient under 40 years of age, while in the older population (>50 years), it is frequently found in patients with chronic hypertension. The most likely cause of hyalinosis, segmental glomerular, seems to occur after repeated arterial hypertension in patients aged 20-50 years." - Anonymous Online Contributor

Unverified Answer

Can hyalinosis, segmental glomerular be cured?

"At present there is no cure for hyalinosis, segmental glomerular in patients who are treated with corticosteroids. But there are some benefits of corticosteroid such as suppression of the disease for 3 to 6 months, alleviating the pain and alleviating the glomerular edema if needed." - Anonymous Online Contributor

Unverified Answer

How many people get hyalinosis, segmental glomerular a year in the United States?

"The number [of people getting hyalinosis, segmental glomerular a year in the United States] is not clear, but the absolute number is probably small--at least 10,000 [per year] or fewer. However, because some of these patients are asymptomatic, this number may be an underestimate because many patients are not getting their follow-up care." - Anonymous Online Contributor

Unverified Answer

What are the signs of hyalinosis, segmental glomerular?

"Hyalinosis of the glomerulus is characterized by increased capillary width, subendothelial edema, and hyaline/lipofuscin hyaline content. Segmental glomerular hyalinosis often appears near the hyalinized tuft and may manifest as decreased on glomerular capillary blood volume." - Anonymous Online Contributor

Unverified Answer

What is hyalinosis, segmental glomerular?

"Hyalinosis, segmental glomerular disease can be differentiated on the basis of clinical and hemodynamic considerations, as well as pathologic findings on light and electron microscopy." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hyalinosis, segmental glomerular?

"Hyalinosis of the renal arteries may be treated with balloon-expandable stents. The arteriole should be preserved without aneurysm. Hyalinosis of the renal vein is more common than hyalinosis of the arteries, and may be treated by renal vein embolization." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hyalinosis, segmental glomerular?

"Results from a recent clinical trial indicate that it is feasible to conduct a prospective, nonrandomized trial of sCG for patients who meet the trial inclusion criteria. Although the data on long-term progression and survival are limited, they are encouraging." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hyalinosis, segmental glomerular?

"This patient demonstrates segmental hyalinosis and hyalinization due to deposition of amyloid. The lack of demonstrable amyloid deposition and segmental glomerulosclerosis suggests a primary hyalinosis or a combination of the two processes. The presence of both processes may also be related to the development of amyloid nephropathy." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in sparsentan for therapeutic use?

"Recent advancements indicate that sparsentan-based treatment can enhance lung function and increase survival in selected ICU patients. Clinicians will have to contend with the need for more patients to be treated and greater complexity in dosing strategies as this drug becomes available in many parts of the world. Sparsentan, a compound that has shown promising effects in non-human primate models of PAH, appears to lead to improved outcomes when used in conjunction with corticosteroids in patients with severe/refractory severe/dominant pulmonary hypertension and is being evaluated in clinical trials." - Anonymous Online Contributor

Unverified Answer

How serious can hyalinosis, segmental glomerular be?

"Severe hyalinosis can lead to renal failure. The early diagnosis and treatment of hyalinosis and the associated glomerulosclerosis may allow for preservation of renal function. Segmental glomerular hyalinosis, especially when associated with focal or diffuse glomerular sclerosis, is associated with worse outcomes." - Anonymous Online Contributor

Unverified Answer

Does hyalinosis, segmental glomerular run in families?

"On the basis of this family study, glomerulus-filtration barrier malfunction is not common in hyalinotic segments of glomeruli. If in fact it occurs, it is a late stage abnormality due to a persistent alteration in the podocyte number." - Anonymous Online Contributor

Unverified Answer

What does sparsentan usually treat?

"[The following are common signs and symptoms and complications of Sparsentan in the Multiple Myeloma & Plasma Disorder Clinical Trials] (https://www.ncbi.nlm.nih.gov/books/NBK229445.pdf). \n- Hematology/Oncology (http://www.hgb.nlm.nih.gov/aboutus/pages/aboutHgb.asp\n- "

"Parasitoid wasp\n\nParasitoid wasps are a highly diverse order which includes species parasitizing a variety of different insect species, but generally include parasitoid Hymenoptera." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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