ClinicalTrials.gg
SuspendedNCT03325322Updated Jan 28, 2026

Inflammation and Stem Cells in Diabetic and Chronic Kidney Disease

A Phase 2 interventional study of Fisetin and Placebo oral capsule in Chronic Kidney Diseases, Diabetes Mellitus and Diabetic Nephropathies, sponsored by Mayo Clinic. Suspended at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

Why this study was suspended
Due to lack of funding
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Kidney Diseases
  • Diabetes Mellitus
  • Diabetic Nephropathies

Keywords

  • Frailty
  • Inflammation
  • Mesenchymal stem cell
  • Mesenchymal stromal cell
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's planned enrollment of 30 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • >11% at screening for the DKD subgroup
  • Body weight >150 kg or >50
  • Pregnancy
  • Active glomerulonephritis treated with 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),
  • infection
  • Active or C infection
  • Total >2x
  • 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 or allergy to Fisetin
  • Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for , 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- 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
  • 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
  • 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
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Treatment

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

    Dietary Supplement: Fisetin

  • Placebo comparator
    Placebo

    Placebo capsules orally for 2 consecutive days

    Drug: Placebo oral capsule

Interventions

  • Dietary supplementFisetin

    Flavonoid family

  • DrugPlacebo oral capsule

    Placebo

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 14 days

  2. 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

    Time frame: 14 days

Secondary outcomes

  1. 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).

    Time frame: 4 months

  2. Kidney function including estimated glomerular filtration rate

    To examine the effect of study drug (compared to placebo) on kidney function.

    Time frame: 4 months

  3. Kidney function including urine protein excretion rate

    To examine the effect of study drug (compared to placebo) on kidney function protein excretion

    Time frame: 4 months

  4. 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)

    Time frame: 12 months

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2018 (actual). Primary completion is estimated for Jan 2027, 108 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2017
First posted
Oct 30, 2017
StartActual
Jan 2, 2018
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Jan 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03325322
Lead sponsor
Mayo Clinic
Responsible party
LaTonya J. Hickson (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Oct 30, 2017
Start date
Jan 2, 2018
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jan 28, 2026

Study contacts

LaTonya J Hickson, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Fisetin

Start the discussion