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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02848131|
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : January 5, 2018
|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 :||20 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|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||May 2021|
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.
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
|Contact: Tammie Volkman, RNfirstname.lastname@example.org|
|Contact: Tamara K Evansemail@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Tammie Volkman, RN 507-266-1944 firstname.lastname@example.org|
|Contact: Tamara K Evans 507-266-1944 email@example.com|
|Principal Investigator: LaTonya Hickson, MD|
|Principal Investigator:||LaTonya J Hickson, MD||Mayo Clinic|