Phase 1
Completed N=18
Study of Sulphoraphane in Chronic Kidney Disease
Chronic Kidney Disease stage3 · Chronic Kidney Disease stage4
Source: ClinicalTrials.gov NCT05153174 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma — 700.0; 718.4 nmol h/L — p=0.931
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-Time Curve (AUC 0-8h) in Plasma |
700.0; 718.4 | 0.931 |
| PRIMARY Area Under the Concentration-Time Curve (AUC 0-8h) in Urine |
12497.0; 24928.8 | 0.224 |
| PRIMARY Number of Participants With an Adverse Event |
5; 7 | — |
Eligibility Criteria
Inclusion Criteria
- eGFR ≥ 20 and 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
Data sourced from ClinicalTrials.gov (NCT05153174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.