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Isis 696844

A Phase III clinical trial is underway to assess the effectiveness and safety of Isis 696844, also known as RO7434656, for patients with primary IgA nephropathy (IgAN) who are at high risk of disease progression. This antisense inhibitor of complement factor B is being studied as a potential treatment option for this kidney condition. The trial aims to evaluate the drug’s impact on proteinuria, kidney function, and overall patient well-being.

Table of Contents

What is ISIS 696844?

ISIS 696844 is a new medication being studied for the treatment of primary IgA nephropathy, a kidney disease. It’s also known by other names, including RO7434656 and ASO FACTOR B.[1] This drug is classified as an antisense oligonucleotide, which is a type of medication that works by targeting specific genetic material in the body.

Target Condition: Primary IgA Nephropathy

Primary IgA nephropathy is a kidney disease where an antibody called immunoglobulin A (IgA) builds up in the kidneys. This can damage the kidneys over time and lead to kidney failure in some cases. ISIS 696844 is being developed to help patients with this condition who are at high risk of their disease getting worse.[1]

How ISIS 696844 Works

ISIS 696844 is designed to work as an antisense inhibitor of complement factor B. In simpler terms, it targets a specific protein (complement factor B) that is thought to play a role in the progression of IgA nephropathy. By inhibiting this protein, the drug aims to slow down or prevent further kidney damage.[1]

Clinical Trial Details

A large clinical trial is currently underway to test the effectiveness and safety of ISIS 696844. Here are some key details about the study:

  • It’s a Phase III trial, which is typically one of the final stages before a drug can be approved for general use.
  • The study is randomized and double-blind, meaning participants are randomly assigned to receive either ISIS 696844 or a placebo, and neither the patients nor the doctors know who is getting which.
  • The main goal is to see if ISIS 696844 can reduce the amount of protein in the urine, which is a sign of kidney damage.
  • The study will also look at how well the kidneys are functioning over time and whether the drug can delay or prevent kidney failure.
  • Researchers will assess how the drug affects fatigue levels in patients.

The medication is given as a subcutaneous injection, which means it’s injected just under the skin.[1]

Eligibility Criteria

To participate in the clinical trial, patients need to meet certain criteria. Some of the key requirements include:

  • Having primary IgA nephropathy confirmed by a kidney biopsy within the last 7 years
  • Being on a stable dose of certain blood pressure medications (ACE inhibitors or ARBs) for at least 90 days
  • Having a certain level of protein in the urine
  • Having kidney function above a certain level
  • Being up to date on certain vaccinations

There are also some factors that would prevent a person from participating, such as pregnancy, certain other medical conditions, or previous treatment with ISIS 696844.[1]

Potential Benefits

If successful, ISIS 696844 could offer several benefits for patients with IgA nephropathy:

  • Reduction in proteinuria (protein in the urine), which is a sign of improved kidney health
  • Slowing down the decline in kidney function
  • Delaying or preventing kidney failure
  • Potential improvement in fatigue levels

However, it’s important to note that these potential benefits are still being studied and are not guaranteed.[1]

Safety Considerations

As with any new medication, safety is a crucial consideration. The clinical trial is designed to carefully monitor for any side effects or safety issues. Some important points to note:

  • Participants need to be vaccinated against certain infections before starting treatment.
  • The study will track any side effects that occur during treatment.
  • Women who could become pregnant need to use effective contraception during the study and for some time after.
  • The maximum daily dose being tested is 70 mg.

It’s important to remember that ISIS 696844 is still an experimental treatment. While it shows promise, more research is needed to fully understand its effectiveness and safety profile.[1]

Aspect Details
Drug Name Isis 696844 (RO7434656)
Drug Type Antisense inhibitor of complement factor B
Condition Studied Primary IgA Nephropathy
Trial Phase Phase III
Primary Objective Evaluate change in proteinuria at Week 37
Secondary Objectives Assess kidney function, time to kidney failure, fatigue levels, safety, and drug pharmacokinetics
Study Design Multicenter, randomized, double-blind, placebo-controlled
Treatment Duration 105 weeks
Key Inclusion Criteria Primary IgAN, significant proteinuria, eGFR ≥ 20 mL/min/1.73 m2
Key Exclusion Criteria Pregnancy, other autoimmune glomerular diseases, uncontrolled blood pressure

FAQ

  • What is Isis 696844 and how does it work? Isis 696844, also known as RO7434656, is an antisense inhibitor of complement factor B. It works by targeting and reducing the activity of a specific protein involved in the complement system, which plays a role in the progression of IgA nephropathy.
  • What is the main goal of this clinical trial? The main goal of this trial is to evaluate the effectiveness of Isis 696844 compared to a placebo in reducing proteinuria (excess protein in urine) in patients with primary IgA nephropathy. This will be measured by the change in urine protein-to-creatinine ratio (UPCR) at Week 37 from the start of the study.
  • Who can participate in this clinical trial? Participants must have primary IgA nephropathy confirmed by a kidney biopsy within the last 7 years, be on maximum tolerated doses of certain blood pressure medications, have significant proteinuria, and have an estimated glomerular filtration rate (eGFR) of 20 mL/min/1.73 m2 or higher. They must also be vaccinated against certain infections and agree to use specified contraception methods.
  • How long does the trial last and what does it involve? The trial lasts for 105 weeks (about 2 years). Participants will be randomly assigned to receive either Isis 696844 or a placebo. The study will measure changes in proteinuria, kidney function, fatigue levels, and monitor for any side effects throughout the trial period.
  • What are the potential benefits and risks of participating in this trial? Potential benefits include access to a new treatment that may help slow the progression of IgA nephropathy. However, as with any clinical trial, there may be risks or side effects that are not yet known. The study will closely monitor participants' safety and any adverse events that may occur during the trial.

Ongoing Clinical Trials on Isis 696844

  • Study on the Effectiveness and Safety of RO7434656 for Patients with Primary IgA Nephropathy at High Risk of Progression

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Greece Italy Poland +1

Glossary

  • IgA Nephropathy: A kidney disease where antibodies called IgA build up in the kidneys, causing inflammation and damage to kidney tissues.
  • Proteinuria: The presence of excess proteins in the urine, which can be a sign of kidney damage or disease.
  • eGFR (estimated glomerular filtration rate): A measure of how well the kidneys are filtering waste from the blood, used to assess kidney function and disease progression.
  • Urine protein-to-creatinine ratio (UPCR): A test that measures the amount of protein in the urine relative to creatinine, used to assess kidney function and proteinuria.
  • Antisense inhibitor: A type of drug that interferes with the production of specific proteins by targeting the genetic instructions for making those proteins.
  • Complement factor B: A protein involved in the complement system, which is part of the body's immune defense but can contribute to kidney damage in IgA nephropathy.
  • Placebo: An inactive substance that looks like the drug being tested but has no medical effect, used as a comparison in clinical trials.
  • Double-blind study: A type of clinical trial where neither the participants nor the researchers know who is receiving the actual drug and who is receiving the placebo.
  • Randomized controlled trial: A study where participants are randomly assigned to different treatment groups to compare the effects of different interventions.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-ro7434656-for-patients-with-primary-iga-nephropathy-at-high-risk-of-progression/