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Chronic Kidney DiseasePhase 2NCT02848131

Senescence in Chronic Kidney Disease

A Phase 2 study testing Group 2: Dasatinib and Group 2: Quercetin in people with Chronic Kidney Disease, run by Mayo Clinic at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The study goal is to assess the effect of senescent cell clearance on senescence burden, physical ability or frailty, and adipose tissue-derived mesenchymal stem cell (MSC) functionality in patients with chronic kidney disease (CKD). Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Chronic Kidney Disease
What is being tested?
Group 2: Dasatinib and Group 2: Quercetin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
Jul 2016to Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 40-80 years
  • Chronic kidney disease estimated glomerular filtration rate (eGFR) 15-45 ml/min/1.73m2
  • Diabetes mellitus and taking diabetes medications

Who cannot join

  • Concomitant glomerulonephritis,
  • Nephrotic syndrome,
  • Solid organ transplantation,
  • Autosomal dominant or recessive polycystic kidney disease,
  • Known renovascular disease,
  • Pregnancy,
Show all 30Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Senescence, Frailty, and Mesenchymal Stem Cell Functionality in Chronic Kidney Disease: Effect of Senolytic Agents

The study goal is to assess the effect of senescent cell clearance on senescence burden, physical ability or frailty, and adipose tissue-derived mesenchymal stem cell (MSC) functionality in patients with chronic kidney disease (CKD).

Read the detailed description

The proposed studies will examine cellular senescence and the effect of senolytic therapy on senescent cell burden, frailty, and adipose-derived mesenchymal stem cell function in individuals with diabetic chronic kidney disease.

Being tested
Group 2: Dasatinib, Group 2: Quercetin
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group 2: DasatinibDrug

    Also called Sprycel

    Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days.

  • Group 2: QuercetinDrug

    Quercetin - take four 250 mg capsules daily (total 1000 mg daily) for 3 consecutive days.

Study groups in NCT02848131
Study groupRoleWhat they receive
Group 1: ObservationalNo interventionObservational Only
Group 2: Dasatinib & QuercetinActive comparatorThe drugs dasatinib and quercetin will be used in this arm
Receives: Drug: Group 2: Dasatinib; Drug: Group 2: Quercetin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in proportion of senescent cells (representing the total senescent cell burden) present

    Assessment of senescence markers in skin, fat, and/or blood at baseline and day 14.

    Measured: Baseline, Day 14

Secondary outcomes (4)

  1. Change in proportion of senescent mesenchymal stem cells present

    Assessment of senescence markers in mesenchymal stem cells at baseline and day 14.

    Measured: Baseline, Day 14

  2. Change in mesenchymal stem cell function

    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.

    Measured: Baseline, Day 14

  3. Change in Frailty index score

    Assessment by Fried and other frailty criteria at baseline and day 14.

    Measured: Baseline, Day 14

  4. Change in kidney function

    Assessment by estimated and measured glomerular filtration rate at baseline, day 14, month 4, and month 12.

    Measured: Baseline, Day 14, Month 4, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02848131
Sponsor's protocol ID
15-005843
Status last verified
May 2026
First submitted
22 Mar 2016
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bian X, Snow ZK, Zinn CJ, Gowan CC, Conley SM, Bratulin AL, Elhusseiny KM, Miller J, Tchkonia T, Kirkland JL, Lerman LO, Hickson LJ. Activin A Antagonism with Follistatin Reduces Kidney Fibrosis, Injury, and Cellular Senescence-Associated Inflammation in Murine Diabetic Kidney Disease. Kidney360. 2025 Mar 28;6(8):1278-1291. doi: 10.34067/KID.0000000776.

    PubMed 40152935

  • Hickson LJ, Langhi Prata LGP, Bobart SA, Evans TK, Giorgadze N, Hashmi SK, Herrmann SM, Jensen MD, Jia Q, Jordan KL, Kellogg TA, Khosla S, Koerber DM, Lagnado AB, Lawson DK, LeBrasseur NK, Lerman LO, McDonald KM, McKenzie TJ, Passos JF, Pignolo RJ, Pirtskhalava T, Saadiq IM, Schaefer KK, Textor SC, Victorelli SG, Volkman TL, Xue A, Wentworth MA, Wissler Gerdes EO, Zhu Y, Tchkonia T, Kirkland JL. Senolytics decrease senescent cells in humans: Preliminary report from a clinical trial of Dasatinib plus Quercetin in individuals with diabetic kidney disease. EBioMedicine. 2019 Sep;47:446-456. doi: 10.1016/j.ebiom.2019.08.069. Epub 2019 Sep 18.

    PubMed 31542391

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Group 2: Dasatinib and Group 2: Quercetin in people with Chronic Kidney Disease, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in proportion of senescent cells (representing the total senescent cell burden) present (time frame: Baseline, Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02848131, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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Senescence in Chronic Kidney Disease (NCT02848131) | AzTrials