Chronic Kidney DiseasesPhase 2NCT03325322
Inflammation and Stem Cells in Diabetic and Chronic Kidney Disease
A Phase 2 study testing Fisetin in people with Chronic Kidney Diseases and Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases, Diabetes Mellitus, Diabetic Nephropathies
- What is being tested?
- Fisetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to Jan 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 30Show fewer
- 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
- Invasive fungal or viral infection
- Inability to tolerate oral medications
- Known hypersensitivity or allergy to Fisetin
- Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6CYP2C9, CYP2C19, CYP1A2, Other (OATP1B1) (Unless willing and able to stop or modify the dosing of the drug) or strong inhibitors or inducers of CYP3A4 (e.g. cyclosporine, tacrolimus or sirolimus).
- Tyrosine kinase inhibitor therapy
- Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc.).
- Subjects on full-dose 325 mg aspirin or other anti-platelet agents (eg. clopidogrel) daily who are unable or unwilling to reduce or hold therapy prior to and during the 2-day drug dosing. Subjects may continue their previous regimen on day 3.
- Baby aspirin (81 mg), if necessary for cardioprotection, will be allowed but encouraged to hold.
- Subjects taking proton pump inhibitors who are unable or unwilling to reduce or hold therapy 2 days prior to and during the 2-day drug dosing. Subjects taking H2-antagonists and unwilling to discontinue therapy for 2 weeks before and one week following enrollment. (See Appendix 4)
- Subjects taking glimepiride or glyburide for diabetes therapy who are unable or unwilling to reduce or hold therapy prior to and during the 2-day drug dosing.
- Subjects taking the following antimicrobial agents: Aminoglycosides, Azole antifungals (fluconazole, miconazole, voriconazole, itraconazole), Macrolides (clarithromycin, erythromycin), Antivirals (nelfinavir, indinavir, saquinavir, ritonavir, elbasvir/grazoprevir), Rifampin
- Corrected QT interval (QTc) >450 msec
- Tobacco use (smoking or chewing; Unless subject willing to reduce use by 50% prior to and during the study) - see Behavioral Modification information below.
- Inability to give informed consent
- Presence of any condition that the Investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Frailty, Inflammation, and Stem Cell Functionality in Chronic Kidney Disease
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.
Read the detailed description
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, particularly diabetic kidney disease. This study will involve a single 2-day oral treatment regimen with fisetin or placebo. Study subjects will be randomized 2:1 to study drug or placebo. Study visits will consist of blood, urine, and abdominal wall skin and subcutaneous fat samplings in addition to testing of physical strength at given time points. Subjects will be followed for a total of 12 months.
- Being tested
- Fisetin, Placebo oral capsule
- Keywords
- Frailty, Inflammation, Mesenchymal stem cell, Mesenchymal stromal cell
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Diabetic Nephropathies, Frailty, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FisetinDietary supplement
Flavonoid family
Placebo oral capsuleDrug
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Fisetin 20 mg/kg/day, orally for 2 consecutive days Receives: Dietary Supplement: Fisetin |
| Placebo | Placebo comparator | Placebo capsules orally for 2 consecutive days Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 14 days
Secondary outcomes (4)
Effect on measures of Frailty including Fried Criteria
To examine the effect of study drug (compared to placebo) on markers of physical frailty (frailty phenotype).
Measured: 4 months
Kidney function including estimated glomerular filtration rate
To examine the effect of study drug (compared to placebo) on kidney function.
Measured: 4 months
Kidney function including urine protein excretion rate
To examine the effect of study drug (compared to placebo) on kidney function protein excretion
Measured: 4 months
Number of participants with treatment-related adverse events including hospitalization
To assess the safety and tolerability of study drug taken over two days (compared to placebo)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start2 Jan 2018
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Why it stopped: Due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LaTonya J. Hickson, Mayo Clinic
- Investigators
- LaTonya J Hickson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325322
- Sponsor's protocol ID
- 16-010521
- Status last verified
- Jan 2026
- First submitted
- 12 Oct 2017
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40152935
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty, Inflammation, and Stem Cell Functionality in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03325322
- Acronym / sponsor ID
- 16-010521
- Keywords
- Frailty, Inflammation, Mesenchymal stem cell, Mesenchymal stromal cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to lack of funding
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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, particularly diabetic kidney disease. This study will involve a single 2-day oral treatment regimen with fisetin or placebo. Study subjects will be randomized 2:1 to study drug or placebo. Study visits will consist of blood, urine, and abdominal wall skin and subcutaneous fat samplings in addition to testing of physical strength at given time points. Subjects will be followed for a total of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: FisetinFisetin 20 mg/kg/day, orally for 2 consecutive days |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo capsules orally for 2 consecutive days |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FisetinFlavonoid family | Dietary supplement | Treatment |
| Placebo oral capsuleAlso: PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in inflammatory markers including C-reactive protein
Time frame: 14 days
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
Effect on Mesenchymal stem cell function including cell migration
Time frame: 14 days
To examine the effect of study drug (compared to placebo) on mesenchymal stem cell function and vitality measured at baseline and day 14
4 secondary outcomes
Effect on measures of Frailty including Fried Criteria
Time frame: 4 months
Kidney function including estimated glomerular filtration rate
Time frame: 4 months
Kidney function including urine protein excretion rate
Time frame: 4 months
Number of participants with treatment-related adverse events including hospitalization
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Derived from this study: PubMed 40152935Bian 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LaTonya J Hickson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fisetin in people with Chronic Kidney Diseases and Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammatory markers including C-reactive protein (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03325322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.