IONIS-FB-LRx for Kidney Diseases

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
IONIS Investigative Site, Vancouver, Canada
Kidney Diseases+2 More
IONIS-FB-LRx - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug that reduces the amount of a protein in the blood can improve kidney function in people with IgA nephropathy.

See full description

Eligible Conditions

  • Kidney Diseases
  • Primary IgA Nephropathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether IONIS-FB-LRx will improve 1 primary outcome and 5 secondary outcomes in patients with Kidney Diseases. Measurement will happen over the course of Baseline to Week 29.

Baseline to Week 29
Absolute Reduction in Albuminuria (UACr Ratio)
Absolute Reduction in Proteinuria (UPCr Ratio)
Week 29
Absolute Reduction in 24-hour Urine Protein Excretion
Percent Reduction in 24-hour Urine Protein Excretion
Up to Week 29
Percent Change from Baseline in Plasma AH50
Percent Change from Baseline in Plasma Factor B (FB)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

IONIS-FB-LRx
1 of 1
Experimental Treatment

This trial requires 25 total participants across 1 different treatment group

This trial involves a single treatment. IONIS-FB-LRx is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

IONIS-FB-LRx
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 29 (if participant discontinues study drug prior to week 25, baseline and 4 weeks after the last dose of study drug will be measured)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to week 29 (if participant discontinues study drug prior to week 25, baseline and 4 weeks after the last dose of study drug will be measured) for reporting.

Closest Location

IONIS Investigative Site - Vancouver, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal OR use a highly effective method of birth control
Biopsy-proven primary immunoglobulin A (IgA) nephropathy
Hematuria
Proteinuria

Patient Q&A Section

How many people get glomerulonephritis, iga a year in the United States?

"It is estimated that 10.7 million adults have glomerulonephritis or IgA nephropathy each year along with an additional 3.2 million adults are estimated to have glomerulonephritis or IgA nephropathy and are currently not listed as a chronic renal disease in the United States. The actual number of patients with glomerulonephritis or IgA nephropathy requiring chronic dialysis treatment is much higher." - Anonymous Online Contributor

Unverified Answer

What is glomerulonephritis, iga?

"Glomerulonephritis and iga can both be suspected without knowing the underlying cause. Glomerulonephritis is a result of the immune system's attack on the body's own basement membrane and is the most common cause of kidney disease. In people with a problem of kidney function, it is important to rule in iga because it is treatable. However, it is still a rare disease with 5-10 cases per 1000 per year in the US. The IGT test can typically be done as a screening test to screen for an antibody, which should be tested for in patients with high risk factors. IGT is a common diagnosis in children, and thus screening for a positive IGT should be pursued." - Anonymous Online Contributor

Unverified Answer

What causes glomerulonephritis, iga?

"Inherited or sporadic, autoimmune or non-autoimmune, and systemic or local causes often coexist in GN. A multifactorial mechanism may underlie most of the nephrotic and erosive GN cases." - Anonymous Online Contributor

Unverified Answer

What are the signs of glomerulonephritis, iga?

"In this patient with thrombotic thrombocytopenic purpura and systemic lupus erythematosus, a biopsy revealed a glomerular picture with predominant global sclerosis, focal membranous casts and glomerular calcifications, all of which were compatible with both systemic vasculitis and glomerulonephritis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glomerulonephritis, iga?

"Treatment of IgA-mediated glomerulonephritis typically consists of corticosteroids. Immunosuppression will vary based on the course of the disease. Antibodies are not considered significant in most cases, so treatment usually consists of corticosteroids, such as prednisone or methylprednisolone. There is no cure for IgA-mediated GN; therefore, treatment is focused on symptom control, control of kidney damage, and overall patient comfort. The optimal treatment has not been established, but therapy may include azathioprine, rituximab, intravenous immunoglobulins, and splenectomy, but not steroid-sparing therapy." - Anonymous Online Contributor

Unverified Answer

Can glomerulonephritis, iga be cured?

"We can speculate on the possibility of spontaneous recovery if good control of blood or other parameters is maintained. We suggest that a corticosteroid dosage that is adequate for the current state of disease is sufficient but not complete." - Anonymous Online Contributor

Unverified Answer

Does ionis-fb-lrx improve quality of life for those with glomerulonephritis, iga?

"IIS-fb-lrx was associated with increased HRQOL and reduction in the number of attacks of FSG despite being equivalent in efficacy to FNAB. This suggests a role for the immunological response in the pathophysiolgy of this glomerulonephritis." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving ionis-fb-lrx?

"The clinical trials for iFN were the first to test the safety and efficacy of an antibody for this disease in humans. More than one clinical trial has been published employing an anti-human IgG antibody to this antigen and human IgM IgM antibody to the antigen, and each study reports a decrease in human IgM and IgG antibodies that are detectable at the end of the study. IgM antibodies are more durable than IgG." - Anonymous Online Contributor

Unverified Answer

How serious can glomerulonephritis, iga be?

"IgA nephropathy of nephritic syndrome of recurrent glomerulonephritis in childhood has a poor prognosis due to the development of end-stage kidney disease in half of cases and progressive deterioration of renal function in the rest of the cases." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for glomerulonephritis, iga?

"Patients with glomerulonephritis, iga and IgA nephropathy should consider clinical trial for rituximab in clinical practice and should continue to receive treatment for any contraindication in further clinical trials." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating glomerulonephritis, iga?

"The most promising antineoplastic agents that were being developed when studies were published on iga, including Bortezomib, have been less successful when combined for therapy of proliferative glomerulonephritis. Some agents have actually had more success when used for iga than as antineoplastic agents. Other antineoplastics that are used for iga include Rituximab." - Anonymous Online Contributor

Unverified Answer

Is ionis-fb-lrx safe for people?

"Patients who take ionis-fb-l rx have only a small absolute risk of experiencing life-threatening or fatal allergic reactions, and a low percentage of adverse drug reactions (<4% in patients that had experienced a life-threatening allergic reaction)." - 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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