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Senescence in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02848131
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
LaTonya J. Hickson, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE March 22, 2016
First Posted Date  ICMJE July 28, 2016
Last Update Posted Date September 17, 2018
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02848131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Senescence in Chronic Kidney Disease
Official Title  ICMJE Senescence, Frailty, and Mesenchymal Stem Cell Functionality in Chronic Kidney Disease: Effect of Senolytic Agents
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • No Intervention: Group 1: Observational
    Observational Only
  • Active Comparator: Group 2: Dasatinib & Quercetin
    The drugs dasatinib and quercetin will be used in this arm
    Interventions:
    • Drug: Group 2: Dasatinib
    • Drug: Group 2: Quercetin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 27, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Concomitant glomerulonephritis,
  2. Nephrotic syndrome,
  3. Solid organ transplantation,
  4. Autosomal dominant or recessive polycystic kidney disease,
  5. Known renovascular disease,
  6. Pregnancy,
  7. Active immunosuppression therapy,
  8. Hemoglobin A1c≥11% at screening,
  9. History of active substance abuse (including alcohol) within the past 2 years,
  10. Current alcohol abuse (>3 alcoholic beverages/day or >21 per week),
  11. Body weight >150 kg or body mass index>50
  12. Human immunodeficiency virus infection
  13. Active hepatitis B or C infection
  14. Tyrosine kinase inhibitor therapy
  15. Known hypersensitivity or allergy to dasatinib or quercetin
  16. Inability to give informed consent
  17. Uncontrolled systemic lupus erythematosus
  18. Uncontrolled pleural/pericardial effusions or ascites
  19. New invasive cancer except non-melanoma skin cancers
  20. Invasive fungal or viral infection
  21. Inability to tolerate oral medications
  22. Total bilirubin>2x upper limit of normal
  23. 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.
  24. Subjects on strong inhibitors of CYP3A4.
  25. Subjects on therapeutic doses of anticoagulants (e.g. warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc).
  26. Subjects on antiplatelet agents (e.g. full dose aspirin which is deemed mandatory for treatment, clopidogrel, etc.). Baby aspirin, if necessary for cardioprotection, will be allowed.
  27. Subjects on quinolone antibiotic therapy for treatment or for prevention of infections within 10 days
  28. Subjects taking H2-antagonists or proton pump inhibitors and unwilling to discontinue therapy 1 week prior and 2 weeks following enrollment.
  29. Corrected QT interval (QTc)>450 msec
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tammie Volkman, RN 507-266-1944 volkman.tammie@mayo.edu
Contact: Erin Wissler Gerdes 507-266-1944 wisslergerdes.erin@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02848131
Other Study ID Numbers  ICMJE 15-005843
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LaTonya J. Hickson, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: LaTonya J Hickson, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP