Senescence in Chronic Kidney Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02848131|
Recruitment Status : Enrolling by invitation
First Posted : July 28, 2016
Last Update Posted : April 4, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Drug: Group 2: Dasatinib Drug: Group 2: Quercetin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Senescence, Frailty, and Mesenchymal Stem Cell Functionality in Chronic Kidney Disease: Effect of Senolytic Agents|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||April 2025|
|Estimated Study Completion Date :||April 2025|
No Intervention: Group 1: Observational
Active Comparator: Group 2: Dasatinib & Quercetin
The drugs dasatinib and quercetin will be used in this arm
Drug: Group 2: Dasatinib
Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days.
Other Name: Sprycel
Drug: Group 2: Quercetin
Quercetin - take four 250 mg capsules daily (total 1000 mg daily) for 3 consecutive days.
- Change in proportion of senescent cells (representing the total senescent cell burden) present [ Time Frame: Baseline, Day 14 ]Assessment of senescence markers in skin, fat, and/or blood at baseline and day 14.
- Change in proportion of senescent mesenchymal stem cells present [ Time Frame: Baseline, Day 14 ]Assessment of senescence markers in mesenchymal stem cells at baseline and day 14.
- Change in mesenchymal stem cell function [ Time Frame: Baseline, Day 14 ]Assessment of functional studies in mesenchymal stem cells at baseline and day 14. Number of subjects with change in stem cell function related to treatment.
- Change in Frailty index score [ Time Frame: Baseline, Day 14 ]Assessment by Fried and other frailty criteria at baseline and day 14.
- Change in kidney function [ Time Frame: Baseline, Day 14, Month 4, Month 12 ]Assessment by estimated and measured glomerular filtration rate at baseline, day 14, month 4, and month 12.
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|Ages Eligible for Study:||40 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age 40-80 years
- Chronic kidney disease estimated glomerular filtration rate (eGFR) 15-45 ml/min/1.73m2
- Diabetes mellitus and taking diabetes medications
- Concomitant glomerulonephritis,
- Nephrotic syndrome,
- Solid organ transplantation,
- Autosomal dominant or recessive polycystic kidney disease,
- Known renovascular disease,
- Active immunosuppression therapy,
- Hemoglobin A1c≥10% at screening,
- History of active substance abuse (including alcohol) within the past 2 years,
- Current alcohol abuse (>3 alcoholic beverages/day or >21 per week),
- Body weight >150 kg or body mass index>50
- Human immunodeficiency virus infection
- Active hepatitis B or C infection
- Tyrosine kinase inhibitor therapy
- Known hypersensitivity or allergy to dasatinib or quercetin
- Inability to give informed consent
- 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
- Total bilirubin>2x upper limit of normal
- Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g. cyclosporine, tacrolimus or sirolimus). If antifungals are absolutely necessary from an infectious disease perspective, then they will be allowed only if the levels are therapeutic.
- Subjects on strong inhibitors of CYP3A4.
- Subjects on therapeutic doses of anticoagulants (Warfarin (Coumadin);Rivaroxaban (Xarleto); Apixaban (Eliquis); Dabigatran (Pradaxa, Prazaxa) or Other).
- Subjects on antiplatelet agents ((Clopidogrel (Plavix); Dipyridamole + Asprin (Aggrenox); Ticagrelor (Brilinta); Prasugrel (Effient); Ticlopidine (Ticlid) or Other) who are unable or unwilling to reduce or hold therapy prior to and during the 3-day drug dosing. Subjects may continue their previous regimen on day 4.
- Subjects on quinolone antibiotic therapy for treatment or for prevention of infections within 10 days
- Subjects taking H2-antagonists or proton pump inhibitors and unwilling to discontinue therapy 1 week prior and 2 weeks following enrollment.
- Corrected QT interval (QTc)>450 msec
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848131
|United States, Florida|
|Mayo Clinic Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||LaTonya J Hickson, MD||Mayo Clinic|
Documents provided by LaTonya J. Hickson, Mayo Clinic:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||LaTonya J. Hickson, Principal Investigator, Mayo Clinic|
|Other Study ID Numbers:||
|First Posted:||July 28, 2016 Key Record Dates|
|Last Update Posted:||April 4, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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