- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03325322
Inflammation and Stem Cells in Diabetic and Chronic Kidney Disease
April 3, 2023 updated by: LaTonya J. Hickson, Mayo Clinic
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.
Study Overview
Status
Suspended
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo capsules orally for 2 consecutive days
|
Placebo
Other Names:
|
Experimental: Treatment
Fisetin 20 mg/kg/day, orally for 2 consecutive days
|
Flavonoid family
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
14 days
|
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
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect on measures of Frailty including Fried Criteria
Time Frame: 4 months
|
To examine the effect of study drug (compared to placebo) on markers of physical frailty (frailty phenotype).
|
4 months
|
Kidney function including estimated glomerular filtration rate
Time Frame: 4 months
|
To examine the effect of study drug (compared to placebo) on kidney function.
|
4 months
|
Kidney function including urine protein excretion rate
Time Frame: 4 months
|
To examine the effect of study drug (compared to placebo) on kidney function protein excretion
|
4 months
|
Number of participants with treatment-related adverse events including hospitalization
Time Frame: 12 months
|
To assess the safety and tolerability of study drug taken over two days (compared to placebo)
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: LaTonya J Hickson, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2018
Primary Completion (Anticipated)
December 1, 2025
Study Completion (Anticipated)
December 1, 2026
Study Registration Dates
First Submitted
October 12, 2017
First Submitted That Met QC Criteria
October 24, 2017
First Posted (Actual)
October 30, 2017
Study Record Updates
Last Update Posted (Actual)
April 5, 2023
Last Update Submitted That Met QC Criteria
April 3, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-010521
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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