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Antisense Inhibitor

IONIS-FB-LRx for IgA Nephropathy

Phase 2

Waitlist Available

Research Sponsored by Ionis Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

Study Summary

This trial will test a new drug, IONIS-FB-LRx, to see if it is effective and safe in treating primary IgA nephropathy, a kidney disease.

Who is the study for?

Adults with confirmed primary IgA nephropathy, a kidney disease marked by blood and protein in urine, can join this trial. They must not be pregnant or breastfeeding and should use effective birth control if necessary. People with recent major health events, certain immune deficiencies, severe infections, very low kidney function, or other specific kidney diseases cannot participate.Check my eligibility

What is being tested?

The trial is testing IONIS-FB-LRx's ability to safely treat IgA nephropathy by inhibiting complement factor B. It will also assess how the drug affects plasma factor B levels and serum activity related to the body's defense (complement) system.See study design

What are the potential side effects?

While specific side effects of IONIS-FB-LRx are not listed here, antisense drugs like it may cause injection site reactions, flu-like symptoms, potential liver issues and changes in blood test results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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's timeline: 3 weeks for screening, Varies for treatment, and 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent Reduction in 24-hour Urine Protein Excretion

Secondary outcome measures

Absolute Reduction in 24-hour Urine Protein Excretion

Absolute Reduction in Albuminuria (UACr Ratio)

Absolute Reduction in Proteinuria (UPCr Ratio)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: IONIS-FB-LRxExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor

146 Previous Clinical Trials

15,259 Total Patients Enrolled

Media Library

IONIS-FB-LRx (Antisense Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04014335 — Phase 2

IONIS-FB-LRx (Antisense Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04014335 — Phase 2

IgA Nephropathy Research Study Groups: IONIS-FB-LRx

IgA Nephropathy Clinical Trial 2023: IONIS-FB-LRx Highlights & Side Effects. Trial Name: NCT04014335 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study accept participants who are at least 18 years of age?

"This medical research is seeking out volunteers who are aged between 18 and 75 years old."

Answered by AI

Is there a cap on the amount of participants involved in this experiment?

"Affirmative. Clinicaltrials.gov data suggests that this clinical trial, which was initially listed on December 4th 2019, is currently enrolling participants. About 25 people need to be recruited from 2 sites."

Answered by AI

Can I join this experiment as a participant?

"This clinical trial is seeking 25 individuals, aged 18 to 75, who are suffering from kidney diseases. In order for the participants to be eligible they must also abide by certain criteria: females must have been rendered infertile or post-menopausal and if not then use a highly effective form of birth control; biopsy results confirm diagnosis of primary immunoglobulin A (IgA) nephropathy; presence of hematuria and proteinuria."

Answered by AI

Are enrollments for this experiment ongoing?

"The details available on the clinicaltrials.gov website show that this medical study is currently accepting participants; it was first announced in December 4th 2019 and its most recent update took place August 10th 2022."

Answered by AI

Has the FDA granted authorization for IONIS-FB-LRx?

"We assign IONIS-FB-LRx a score of 2 on the safety scale. This is due to Phase 2 trials indicating that there are some data points supporting its security, yet still no evidence for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA Nephropathy

2019. "A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA Nephropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04014335.

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