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Phytochemical
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
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)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My kidney function is low but not extremely poor, and it has been getting worse over the last year.
Select...
I am between 18 and 80 years old.
Select...
I can swallow pills without difficulty.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Longitudinal change in 8-isoprostane in plasma
Longitudinal change in 8-isoprostane in urine
Longitudinal change in alanine transaminase (ALT) as part of comprehensive metabolic panel (CMP)
+25 moreSide effects data
From 2013 Phase 2 trial • 44 Patients • NCT0147499319%
Vomiting
15%
Abdominal pain
15%
Increased Flatulence
15%
SGPT outside of reference range
15%
Increased aggressions
12%
Increased irritability
12%
Constipation
12%
Diarrhea
12%
Seasonal allergy exacerbation
12%
Fever
12%
Headache
8%
Insomnia
8%
Increased stubbornness
8%
Abnormal WBC count
8%
Seizures
8%
Cough
4%
Hyperactivity
4%
Increased appetite
4%
Abnormal platelet count
4%
TSH outside of reference range
4%
Increased agitation
4%
Crying spells
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sulforaphane-rich Broccoli Sprout Extract
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sulforaphane (Avmacol Extra Strength)Experimental Treatment1 Intervention
Four tablets of Sulforaphane (Avmacol Extra Strength) per day. The tablets will be provided by Nutramax.
Group II: PlaceboPlacebo Group1 Intervention
Nutramax will provide the matched placebo tablets.
Find a Location
Who is running the clinical trial?
Nutramax Laboratories, Inc.Industry Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,150 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,492 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is low but not extremely poor, and it has been getting worse over the last year.I am currently receiving treatment for cancer.I am currently taking blood thinners or medications that affect my immune system.You have been diagnosed with dementia in the past.I am between 18 and 80 years old.I have severe heart failure, an EF of 30% or less, or was hospitalized for it recently.I can swallow pills without difficulty.I have a condition that slows my stomach from emptying.Your blood potassium level is higher than 5.5 mEq/L.My doctor expects me to live more than a year despite my other health issues.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Sulforaphane (Avmacol Extra Strength)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals over the age of 45 participate in this medical trial?
"This clinical trial is open to all individuals between the ages of 18 and 80, provided they meet all other criteria."
Answered by AI
What is the eligibility criteria for enrolment in this research project?
"To be eligible for this medical trial, applicants must have chronic kidney disease and should fall between the ages of 18 to 80. The research team is targeting a total enrolment size of 100 participants."
Answered by AI
Could you appraise the potential hazards of using Sulforaphane (Avmacol Extra Strength)?
"We have assigned Sulforaphane (Avmacol Extra Strength) a rating of 2 on the safety scale, due to preliminary data confirming its security but no evidence indicating efficacy."
Answered by AI
Are there any vacant slots for participants in this research?
"Confirmed, the trial is no longer actively recruiting. It was initially posted on May 1st 2023 and last updated April 4th 2023. Despite this, there are 526 other clinical trials presently enrolling patients at this time."
Answered by AI
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