Status:
SUSPENDED
Inflammation and Stem Cells in Diabetic and Chronic Kidney Disease
Lead Sponsor:
Mayo Clinic
Conditions:
Chronic Kidney Diseases
Diabetes Mellitus
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03325322
Start Date
January 2 2018
End Date
December 1 2026
Last Update
June 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905