Sulforaphane for Chronic Kidney Disease

Phase 2

Recruiting

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

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

Must have

Estimated glomerular filtration rate (eGFR) ≥ 20 and < 60 mL/min/1.73m2 and a decline in eGFR of ≥ 3 ml/min/1.73m2 /year in the previous 12 ± 2 months

Age ≥ 18 years and ≤ 80 years

Must not have

On anticoagulants or immunosuppression

New York Heart Association Class 3 or 4 heart failure symptoms, known Ejection Fraction (EF) ≤ 30% or hospital admission for heart failure within the past 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)

Summary

This trial will test if Avmacol ES can reduce kidney disease progression & oxidative stress/inflammation in CKD patients. Funded by NIDDK.

Who is the study for?

Adults aged 18-80 with moderate chronic kidney disease, specifically those whose kidneys are filtering at a reduced rate and have shown decline in the past year. Participants must be able to swallow pills and give consent. Excluded are pregnant or breastfeeding individuals, those on anticoagulants or immunosuppressants, cancer patients, non-English speakers, and anyone with severe health issues affecting survival beyond a year.

What is being tested?

The trial is testing Avmacol Extra Strength's ability to slow down kidney disease progression by comparing it against a placebo. It's double-blind (neither doctors nor participants know who gets what), randomized (participants randomly assigned to groups), and aims to see if this supplement can reduce oxidative stress and inflammation in CKD patients.

What are the potential side effects?

Potential side effects of Sulforaphane (Avmacol ES) may include gastrointestinal discomfort due to its active ingredients derived from broccoli seed extract. However, specific side effects will be monitored throughout the study given its investigational nature.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function is low but not extremely poor, and it has been getting worse over the last year.

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I am between 18 and 80 years old.

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I can swallow pills without difficulty.

Exclusion Criteria

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

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I am currently taking blood thinners or medications that affect my immune system.

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I have severe heart failure, an EF of 30% or less, or was hospitalized for it recently.

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My doctor expects me to live more than a year despite my other health issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6)

This trial's timeline: 3 weeks for screening, Varies for treatment, and seven timepoints per patient (baseline; month 1; month 2; month 3; month 4; month 5, and month 6) for reporting.