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Senolytic Agent
Senolytic Therapy for Chronic Kidney Disease
Phase 2
Waitlist Available
Led By LaTonya J Hickson, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic kidney disease estimated glomerular filtration rate (eGFR) 15-45 ml/min/1.73m2
Diabetes mellitus and taking diabetes medications
Must not have
New invasive cancer except non-melanoma skin cancers
Inability to tolerate oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 14, month 4, month 12
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether getting rid of senescent cells can help people with chronic kidney disease by reducing senescence burden, improving physical ability or frailty, and increasing mesenchymal stem cell functionality.
Who is the study for?
This trial is for adults aged 40-80 with chronic kidney disease (eGFR 15-45 ml/min/1.73m2) and diabetes on medication. Excluded are those with recent substance abuse, HIV, hepatitis B/C, pregnancy, certain heart conditions or allergies to the drugs tested, among other criteria.
What is being tested?
The study tests whether Dasatinib and Quercetin can reduce aging cells in patients with chronic kidney disease to improve physical function and stem cell health. Participants will be grouped to receive either drug combination.
What are the potential side effects?
Potential side effects of Dasatinib and Quercetin may include changes in blood counts leading to increased risk of infections or bleeding, nausea, diarrhea, muscle cramps, fatigue, fluid retention around the heart or lungs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is reduced, with an eGFR between 15-45.
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I have diabetes and am on medication for it.
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I am between 40 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a new cancer diagnosis that is not a non-melanoma skin cancer.
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I cannot take medications by mouth.
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I am currently on medication to suppress my immune system.
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My weight is over 150 kg or my BMI is over 50.
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I am not willing to stop my acid reflux medication for 3 weeks.
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My lupus is not under control.
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I have unmanaged fluid buildup in my chest or abdomen.
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I am HIV positive.
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I am unable to understand and give consent for treatment.
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I am on a medication that targets cancer growth.
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I have taken quinolone antibiotics in the last 10 days.
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I am taking medication that strongly affects liver enzyme CYP3A4.
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I do not have an active hepatitis B or C infection.
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I have a kidney condition called glomerulonephritis.
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I have an invasive fungal or viral infection.
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I have been diagnosed with kidney artery disease.
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I have a genetic form of polycystic kidney disease.
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I have been diagnosed with nephrotic syndrome.
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I have had a solid organ transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 14, month 4, month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 14, month 4, month 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in proportion of senescent cells (representing the total senescent cell burden) present
Secondary study objectives
Change in Frailty index score
Change in kidney function
Change in mesenchymal stem cell function
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Group 1: ObservationalActive Control1 Intervention
Observational Only
Group II: Group 2: Dasatinib & QuercetinActive Control2 Interventions
The drugs dasatinib and quercetin will be used in this arm
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,060,993 Total Patients Enrolled
LaTonya J Hickson, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is reduced, with an eGFR between 15-45.Your total bilirubin level is more than twice the normal limit.I have a new cancer diagnosis that is not a non-melanoma skin cancer.I cannot take medications by mouth.I am currently on medication to suppress my immune system.My weight is over 150 kg or my BMI is over 50.I am not willing to stop my acid reflux medication for 3 weeks.My lupus is not under control.I have unmanaged fluid buildup in my chest or abdomen.I am taking blood thinners or antiplatelet drugs and cannot stop them for the trial.I am HIV positive.I am unable to understand and give consent for treatment.I am on a medication that targets cancer growth.I have taken quinolone antibiotics in the last 10 days.You drink more than 3 alcoholic drinks a day or more than 21 drinks a week.I am taking medication that strongly affects liver enzyme CYP3A4.I do not have an active hepatitis B or C infection.I have diabetes and am on medication for it.Your heart's QT interval is longer than 450 milliseconds.You are allergic to dasatinib or quercetin.I have a kidney condition called glomerulonephritis.I have an invasive fungal or viral infection.You have had problems with drugs or alcohol in the last 2 years.I have been diagnosed with kidney artery disease.I have a genetic form of polycystic kidney disease.Your hemoglobin A1c level is 10% or higher during screening.I am not on medication that affects certain liver enzymes or only take them if necessary and monitored.I have been diagnosed with nephrotic syndrome.I have had a solid organ transplant.I am between 40 and 80 years old.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Observational
- Group 2: Group 2: Dasatinib & Quercetin