NCT03325322

Brief Summary

The proposed studies will examine the effect of fisetin on adipose tissue-derived mesenchymal stem/stromal cell function, kidney function, markers of inflammation, and physical function in individuals with advanced chronic kidney disease.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
7mo left

Started Jan 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2018Jan 2027

First Submitted

Initial submission to the registry

October 12, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2018

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

9 years

First QC Date

October 12, 2017

Last Update Submit

January 26, 2026

Conditions

Chronic Kidney DiseasesDiabetes MellitusDiabetic Nephropathies

Keywords

FrailtyInflammationMesenchymal stem cellMesenchymal stromal cell

Outcome Measures

Primary Outcomes (2)

  • Change in inflammatory markers including C-reactive protein

    To examine the effect of study drug (compared to placebo) on markers of inflammation in skin, fat, plasma, and urine measured at baseline and day 14

    14 days

  • Effect on Mesenchymal stem cell function including cell migration

    To examine the effect of study drug (compared to placebo) on mesenchymal stem cell function and vitality measured at baseline and day 14

    14 days

Secondary Outcomes (4)

  • Effect on measures of Frailty including Fried Criteria

    4 months

  • Kidney function including estimated glomerular filtration rate

    4 months

  • Kidney function including urine protein excretion rate

    4 months

  • Number of participants with treatment-related adverse events including hospitalization

    12 months

Study Arms (2)

Treatment

EXPERIMENTAL

Fisetin 20 mg/kg/day, orally for 2 consecutive days

Dietary Supplement: Fisetin

Placebo

PLACEBO COMPARATOR

Placebo capsules orally for 2 consecutive days

Drug: Placebo oral capsule

Interventions

FisetinDIETARY_SUPPLEMENT

Flavonoid family

Treatment
Placebo oral capsuleDRUG

Placebo

Also known as: Placebo
Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-80 years
  • Chronic kidney disease estimated glomerular filtration rate (eGFR) 15-60 ml/min/1.73m2
  • For the diabetic kidney disease (DKD) subgroup: Diabetes mellitus (on medication)

You may not qualify if:

  • Hemoglobin A1c\>11% at screening for the DKD subgroup
  • Body weight \>150 kg or body mass index\>50
  • Pregnancy
  • Active glomerulonephritis treated with immunosuppressive therapy
  • Solid organ transplantation (eg. kidney, pancreas, liver, lung, heart)
  • Active immunosuppression therapy
  • History of active substance abuse (including alcohol) within the past 2 years,
  • Current alcohol abuse (\>3 alcoholic beverages/day or \>21 per week),
  • Human immunodeficiency virus infection
  • Active hepatitis B or C infection
  • Total bilirubin \>2x upper limit of normal
  • Uncontrolled psychiatric disorder
  • Uncontrolled systemic lupus erythematosus
  • Uncontrolled pleural/pericardial effusions or ascites
  • New invasive cancer except non-melanoma skin cancers
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Bian X, Snow ZK, Zinn CJ, Gowan CC, Conley SM, Bratulin AL, Elhusseiny KM, Miller J, Tchkonia T, Kirkland JL, Lerman LO, Hickson LJ. Activin A Antagonism with Follistatin Reduces Kidney Fibrosis, Injury, and Cellular Senescence-Associated Inflammation in Murine Diabetic Kidney Disease. Kidney360. 2025 Mar 28;6(8):1278-1291. doi: 10.34067/KID.0000000776.

    PMID: 40152935DERIVED

Related Links

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes MellitusDiabetic NephropathiesFrailtyInflammation

Interventions

fisetin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetes Complications

Study Officials

  • LaTonya J Hickson, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 30, 2017

Study Start

January 2, 2018

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)