What side effects are associated with this type of intervention?

Common treatments for Nephrotic Syndrome include glucocorticoids, cyclophosphamide, and mycophenolate mofetil. Glucocorticoids can cause side effects such as weight gain, hypertension, hyperglycemia, increased risk of infections, and osteoporosis. Cyclophosphamide may lead to bone marrow suppression, increased risk of infections, hemorrhagic cystitis, and potential infertility. Mycophenolate mofetil can cause gastrointestinal disturbances, bone marrow suppression, and increased susceptibility to infections. These treatments aim to reduce proteinuria and preserve kidney function but come with significant potential side effects that need to be managed carefully.

What prior FDA approvals exist?

FDA-approved treatments for Nephrotic Syndrome typically include immunosuppressive agents such as cyclophosphamide, prednisone, and rituximab. These drugs work by reducing inflammation and suppressing the immune system to prevent further kidney damage. While Vericiguat, a stimulator of soluble guanylyl cyclase, is being studied for coronary vascular dysfunction, there is no direct mention of similar drugs being approved for Nephrotic Syndrome.

What other types of research exist?

Promising novel alternatives for Nephrotic Syndrome patients include: 1) Metformin, which has shown potential in reducing cyst formation in polycystic kidney disease and may have benefits in nephrotic conditions. 2) Salsalate, which has demonstrated efficacy in slowing kidney cyst growth in polycystic kidney disease models. 3) Immunoadsorption, an investigational therapy that may be effective in certain kidney diseases, including those with antibody involvement. These alternatives should be discussed with a healthcare provider to determine their suitability and potential benefits for individual patients.

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Stimulator of Soluble Guanylyl Cyclase

Vericiguat for Metabolic Syndrome

Q: What is the mechanism of action of this treatment?

The most common treatments for Nephrotic Syndrome include corticosteroids, which reduce inflammation and immune response; immunosuppressive agents like cyclophosphamide and mycophenolate mofetil, which suppress the immune system to prevent further kidney damage; and supportive therapies such as ACE inhibitors or ARBs, which help control blood pressure and reduce proteinuria. These treatments are crucial for managing symptoms, preventing complications, and preserving kidney function in Nephrotic Syndrome patients. Vericiguat, a stimulator of soluble guanylyl cyclase, works by enhancing nitric oxide signaling, which can improve vascular function and potentially benefit kidney health by improving blood flow and reducing inflammation. While not a standard treatment for Nephrotic Syndrome, its mechanism highlights the importance of vascular health in managing kidney diseases.

Phase 2

Recruiting

Led By Thorsten M Leucker, M.D., Ph.D.

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Presence of the metabolic syndrome defined by the National Cholesterol Education Program, Adult Treatment Panel III (NCEP ATP III) definition, with at least three of the following five criteria: waist circumference > 40 inches (men) or >35 inches (women), blood pressure >130/80 mmHg, fasting triglyceride (TG) level >150 mg/dL, fasting high-density lipoprotein (HDL) cholesterol level <40mg/dL in men or <50mg/dL in women, Fasting blood glucose >100 mg/dL

Age range 35-85 years

Must not have

Inability to lie flat and still for 45 minutes

History as a machinist, welder, metal worker or a similar activity that poses the risk of metal exposure to the eyes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 weeks following initiation of up-titrated dose

Summary

This trial is testing vericiguat, a drug that helps blood vessels relax and widen, in people with metabolic syndrome and poor heart blood flow. The goal is to see if it can improve heart function. The study will use MRI scans and other tests to measure changes in heart health. Vericiguat is currently being tested for chronic heart failure.

Who is the study for?

Adults aged 35-85 with metabolic syndrome as defined by NCEP ATP III, which includes having a large waistline, high blood pressure, elevated fasting triglycerides, low HDL cholesterol levels, and raised fasting blood glucose. Participants should not be pregnant or have metal exposure risks due to past occupations like welding. They must also be able to undergo MRI scans without issues such as claustrophobia.

What is being tested?

The trial is testing Vericiguat against a placebo in individuals with metabolic syndrome and coronary vascular dysfunction. The study is randomized and double-blind meaning neither the participants nor the researchers know who gets the real treatment versus placebo. The effect on coronary vascular function will be measured using cardiac MRI imaging.

What are the potential side effects?

While specific side effects of Vericiguat are not listed here, common ones may include headaches, dizziness due to low blood pressure (especially since those with systolic BP <110 mm Hg are excluded), digestive disturbances or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I meet at least three criteria for metabolic syndrome according to NCEP ATP III.

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I am between 35 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot lie flat and still for 45 minutes.

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I have worked in jobs like machining, welding, or metalworking that could expose my eyes to metal.

Select...

I am using or plan to use medication for heart or blood vessel conditions.

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I am a woman able to have children and am not using birth control.

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I understand the risks, benefits, and alternatives of participating.

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I am currently pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 weeks following initiation of up-titrated dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 weeks following initiation of up-titrated dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 weeks following initiation of up-titrated dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute change in coronary cross-sectional area (in mm²) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)

Absolute change in coronary cross-sectional area (in mm²) within the vericiguat group as assessed by Magnetic Resonance Imaging (MRI)

Relative change in coronary cross-sectional area (as percentage) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)

+1 more

Secondary study objectives

Absolute change in coronary flow (in mL/min) between the vericiguat group and the placebo group as assessed by Magnetic Resonance Imaging (MRI)

Absolute change in coronary flow (in mL/min) within the vericiguat group as assessed by Magnetic Resonance Imaging (MRI)

Changes in E/e' ratio as assessed by echocardiography

+13 more

Side effects data

From 2019 Phase 3 trial • 5050 Patients • NCT02861534

15%

Hypotension

Dizziness

Anaemia

Cardiac failure

Nasopharyngitis

Dyspnoea

Diarrhoea

Pneumonia

Hyperkalaemia

Acute kidney injury

Chronic kidney disease

Syncope

Chronic obstructive pulmonary disease

Gastroenteritis

Sepsis

Ventricular tachycardia

Renal failure

Cardiac failure congestive

Cellulitis

Atrial fibrillation

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Vericiguat

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VericiguatExperimental Treatment1 Intervention

Initial 2.5 mg/day for two weeks, then 5 mg/day for two weeks, and then 10 mg/day for two weeks. Systolic blood pressure will be measured before and following each titration The participant will receive the final titration dose for a total of six weeks.. The drug is administered as an oral tablet once daily.

Group II: PlaceboPlacebo Group1 Intervention

A placebo tablet will be administered orally once daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vericiguat

2023

Completed Phase 4

~5080

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Nephrotic Syndrome include corticosteroids, which reduce inflammation and immune response; immunosuppressive agents like cyclophosphamide and mycophenolate mofetil, which suppress the immune system to prevent further kidney damage; and supportive therapies such as ACE inhibitors or ARBs, which help control blood pressure and reduce proteinuria. These treatments are crucial for managing symptoms, preventing complications, and preserving kidney function in Nephrotic Syndrome patients. Vericiguat, a stimulator of soluble guanylyl cyclase, works by enhancing nitric oxide signaling, which can improve vascular function and potentially benefit kidney health by improving blood flow and reducing inflammation. While not a standard treatment for Nephrotic Syndrome, its mechanism highlights the importance of vascular health in managing kidney diseases.