Senescence in Chronic Kidney Disease

NCT02848131 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: 15-005843
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (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.

  Baseline, Day 14

Secondary Outcomes (4)

• Change in proportion of senescent mesenchymal stem cells present

  Baseline, Day 14

• Change in mesenchymal stem cell function

  Baseline, Day 14

• Change in Frailty index score

  Baseline, Day 14

• Change in kidney function

  Baseline, Day 14, Month 4, Month 12

Study Arms (2)

Group 1: Observational

NO INTERVENTION

Observational Only

Group 2: Dasatinib & Quercetin

ACTIVE COMPARATOR

The drugs dasatinib and quercetin will be used in this arm

Drug: Group 2: Dasatinib; Drug: Group 2: Quercetin

Interventions

Group 2: Dasatinib DRUG

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

Also known as: Sprycel

Group 2: Dasatinib & Quercetin

Group 2: Quercetin DRUG

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

Group 2: Dasatinib & Quercetin

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Concomitant glomerulonephritis,
• Nephrotic syndrome,
• Solid organ transplantation,
• Autosomal dominant or recessive polycystic kidney disease,
• Known renovascular disease,
• Pregnancy,
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 40152935 DERIVED

• 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.

  PMID: 31542391 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• LaTonya J Hickson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: July 28, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)