What is the mechanism of action of this treatment?

Common treatments for Chronic Kidney Disease (CKD) that focus on reducing oxidative stress and inflammation include antioxidants like resveratrol, sulforaphane, and curcumin. These treatments work by activating the NRF2 signaling pathway, which enhances the expression of antioxidant enzymes and reduces oxidative damage. This is crucial for CKD patients because oxidative stress and inflammation contribute significantly to the progression of kidney damage. By mitigating these factors, these treatments can help preserve kidney function and slow disease progression, improving overall patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) that aim to reduce oxidative stress and inflammation include antioxidants like vitamin E and N-acetylcysteine (NAC), and anti-inflammatory agents like glucocorticoids. Vitamin E is generally well-tolerated but high doses can increase bleeding risks. NAC has not shown significant benefits in delaying disease progression but may improve survival in specific cases. Glucocorticoids can lower the risk of end-stage kidney disease but are associated with serious adverse events such as severe infections, particularly at high doses.

What prior FDA approvals exist?

While the provided context does not specify FDA-approved treatments for Chronic Kidney Disease (CKD) that focus on reducing oxidative stress and inflammation, it does mention the study of resveratrol for its potential benefits in improving vascular function in CKD patients by reducing oxidative stress and inflammation. Generally, treatments for CKD often include blood pressure control with ACE inhibitors or ARBs, which can have anti-inflammatory effects. However, specific FDA-approved drugs targeting oxidative stress and inflammation in CKD were not detailed in the provided context.

What other types of research exist?

Promising novel alternatives to resveratrol for CKD patients include: 1) Bardoxolone methyl, which has shown potential in reducing inflammation and oxidative stress in CKD patients. 2) Nrf2 activators, such as dimethyl fumarate, which can enhance antioxidant responses. 3) SGLT2 inhibitors, like dapagliflozin, which have demonstrated benefits in reducing oxidative stress and inflammation in CKD. 4) Anti-inflammatory agents like canakinumab, an IL-1β inhibitor, which may reduce inflammation in CKD. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Polyphenol

Resveratrol for Chronic Kidney Disease

N/A

Waitlist Available

Research Sponsored by Diana Jalal

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 first baseline measurement to 6 weeks then second baseline to 6 weeks

Summary

This trial is testing resveratrol, a natural compound found in grapes and red wine, to see if it can help patients with chronic kidney disease. These patients are at high risk for heart problems and suffer from poor blood vessel function, inflammation, and oxidative stress. The study aims to show that resveratrol can improve blood vessel function and reduce these harmful conditions.

Who is the study for?

This trial is for individuals with Type II diabetes and moderate chronic kidney disease (CKD stage III). They must be taking certain blood pressure medications for over 3 months. People can't join if they have severe heart failure, recent hospitalization, are on immunosuppressants or anticoagulants, pregnant or not using birth control, consume lots of red wine or resveratrol supplements.

What is being tested?

The study tests whether resveratrol improves blood vessel function in CKD patients by reducing stress and inflammation markers. Participants will either receive resveratrol or a placebo to compare effects.

What are the potential side effects?

While the side effects aren't detailed here, common ones associated with resveratrol may include digestive issues like nausea and diarrhea, as well as headaches and dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first baseline measurement to 6 weeks then second baseline to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first baseline measurement to 6 weeks then second baseline to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and first baseline measurement to 6 weeks then second baseline to 6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

% Change of Brachial Artery Flow-mediated Dilation

Secondary study objectives

Change in oxLDL

Side effects data

From 2013 Phase 2 trial • 24 Patients • NCT02114892

25%

Headache

Abdominal pain

Sickness

100%

80%

60%

40%

20%

Study treatment Arm

Resveratrol

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Resveratrol first, then placeboExperimental Treatment2 Interventions

Patients will receive resveratrol 400 mg PO per day in divided doses of 200 mg in the morning and 200 mg in the evening. After a minimum of 2 week washout period, subjects then took placebo for 6 weeks.

Group II: Placebo first, then resveratrolPlacebo Group2 Interventions

Patients will receive placebo pill identical in appearance and taste to the supplement. Subjects took this placebo twice daily, once in the morning and once in the evening. After a minimum of 2 week washout period, subjects then took resveratrol for 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Resveratrol

2014

Completed Phase 3

~730

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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

Common treatments for Chronic Kidney Disease (CKD) that focus on reducing oxidative stress and inflammation include antioxidants like resveratrol, sulforaphane, and curcumin. These treatments work by activating the NRF2 signaling pathway, which enhances the expression of antioxidant enzymes and reduces oxidative damage. This is crucial for CKD patients because oxidative stress and inflammation contribute significantly to the progression of kidney damage. By mitigating these factors, these treatments can help preserve kidney function and slow disease progression, improving overall patient outcomes.

Protective effect of resveratrol against aluminum chloride induced nephrotoxicity in rats.Effect of redox modulating NRF2 activators on chronic kidney disease.