Study of Sulphoraphane in Chronic Kidney Disease

NCT05153174 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: STUDY000067591R01DK128677-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety of the compound sulforaphane that boosts the activity of antioxidant genes in the body to combat oxidative stress. Oxidative stress has been shown experimentally to play a role in kidney disease. This drug has been tested in patients with breast cancer who have normal kidney function, but has never been tested in patients with kidney disease. In this study, the investigators will establish a safe dose for patients with chronic kidney disease based on blood levels achieved in patients with normal kidney function.

Conditions

Chronic Kidney Disease stage3; Chronic Kidney Disease stage4

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma

  Sulforaphane drug levels will be measured in plasma at 0, 1, 2, 4, and 8 hours.

  prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose

• Area Under the Concentration-Time Curve (AUC 0-8h) in Urine

  Sulforaphane drug levels will be measured in urine at 0, 1, 2, 4, and 8 hours.

  prior to initial dose on day 7 and 1, 2, 4, and 8 hours post-dose

• Number of Participants With an Adverse Event

  Adverse Event is any side effect outside of the subject's baseline.

  day 7

Study Arms (2)

2 tablets of Sulforaphane

EXPERIMENTAL

Participants will be given 2 extra strength tablets per day

Drug: Sulforaphane

4 tablets of Sulforaphane

EXPERIMENTAL

Participants will be given 4 extra strength tablets per day

Drug: Sulforaphane

Interventions

Sulforaphane DRUG

This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.

Also known as: Avmacol

2 tablets of Sulforaphane; 4 tablets of Sulforaphane

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eGFR ≥ 20 and \<60 ml/min/m2/year, and a decline in eGFR of ≥ 3 ml/min/m2/year in the previous 12 months
• Blood pressure \<140/90 mm Hg prior to initiation of sulphoraphane
• stable anti-hypertensive regimen for at least one month prior to initiation of sulphoraphane or successful run-in period
• able to provide consent
• able to swallow capsules

You may not qualify if:

• significant co-morbid conditions with life expectancy of \<1 year
• uncontrolled hypertension
• serum potassium of \>5.5 mEq/L at screening
• New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30% or hospital admission for heart failure within the past 3 months
• factors judged to limit adherence to interventions
• current participation in another study
• pregnancy or planning to become pregnant or currently breastfeeding
• history of dementia
• on anticoagulants or immunosuppression
• under treatment for cancer

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

sulforaphane

Limitations and Caveats

At the time of review with the Data Safety Monitoring Committee, the study had consented 21 patients and enrolled 18 patients out of 24 targeted. 2 of the 21 patients were randomized to a 6-tablet Arm, which was removed in the final Protocol Amendment due to moderate side effects/adverse events. 1 patient withdrew before study procedures.

Results Point of Contact

• Title: Dr Thu H. Le, MD, FAHA - Chief of Nephrology
• Organization: University of Rochester Medical Center

thu_le@urmc.rochester.edu

585-273-4259

Study Officials

• Thu H Le, MD, FAHA

  Division of Nephrology Chief

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: May 2, 2022
• Primary Completion: May 25, 2023
• Study Completion: June 8, 2023
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: May 2024 data is available. End date to be determined.
• Access Criteria: clinicaltrials.gov

Locations

US (1)