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Trial record 49 of 523 for:    stem cell kidney

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 : Active, not recruiting
First Posted : July 28, 2016
Results First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
LaTonya J. Hickson, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Kidney Disease
Interventions Drug: Group 2: Dasatinib
Drug: Group 2: Quercetin
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: Observational Group 2: Dasatinib & Quercetin
Hide Arm/Group Description Observational Only

The drugs dasatinib and quercetin will be used in this arm

Group 2: Dasatinib: Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days.

Group 2: Quercetin: Quercetin - take four 250 mg capsules daily (total 1000 mg daily) for 3 consecutive days.

Period Title: Overall Study
Started 5 11
Completed 5 11
Not Completed 0 0
Arm/Group Title Group 1: Observational Group 2: Dasatinib & Quercetin Total
Hide Arm/Group Description Observational Only

The drugs dasatinib and quercetin will be used in this arm

Group 2: Dasatinib: Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days.

Group 2: Quercetin: Quercetin - take four 250 mg capsules daily (total 1000 mg daily) for 3 consecutive days.

Total of all reporting groups
Overall Number of Baseline Participants 5 11 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 11 participants 16 participants
68.0  (9.0) 72.0  (5.0) 70.0  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 11 participants 16 participants
Female
1
  20.0%
2
  18.2%
3
  18.8%
Male
4
  80.0%
9
  81.8%
13
  81.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 11 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
5
 100.0%
10
  90.9%
15
  93.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   9.1%
1
   6.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 11 participants 16 participants
5 11 16
1.Primary Outcome
Title Change in Number of Senescent Cells
Hide Description Change in number of senescence markers in abdominal subcutaneous adipose tissue biopsy at baseline and day 14.
Time Frame Baseline, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Observational Group 2: Dasatinib & Quercetin
Hide Arm/Group Description:
Observational Only

The drugs dasatinib and quercetin will be used in this arm

Group 2: Dasatinib: Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days.

Group 2: Quercetin: Quercetin - take four 250 mg capsules daily (total 1000 mg daily) for 3 consecutive days.

Overall Number of Participants Analyzed 5 9
Mean (Standard Error)
Unit of Measure: number of cells
Baseline 51.73  (8.18) 56.8  (4.79)
Day 14 48.26  (8.18) 43.19  (4.79)
2.Secondary Outcome
Title Change in Proportion of Senescent Mesenchymal Stem Cells Present
Hide Description Assessment of senescence markers in mesenchymal stem cells at baseline and day 14.
Time Frame Baseline, Day 14
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change in Mesenchymal Stem Cell Function
Hide Description 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.
Time Frame Baseline, Day 14
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change in Frailty Index Score
Hide Description Assessment by Fried and other frailty criteria at baseline and day 14.
Time Frame Baseline, Day 14
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change in Kidney Function
Hide Description Assessment by estimated and measured glomerular filtration rate at baseline, day 14, month 4, and month 12.
Time Frame Baseline, Day 14, Month 4, Month 12
Outcome Measure Data Not Reported
Time Frame Adverse Events were collected from baseline through 12 months for each subject
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: Observational Group 2: Dasatinib & Quercetin
Hide Arm/Group Description Observational Only

The drugs dasatinib and quercetin will be used in this arm

Group 2: Dasatinib: Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days.

Group 2: Quercetin: Quercetin - take four 250 mg capsules daily (total 1000 mg daily) for 3 consecutive days.

All-Cause Mortality
Group 1: Observational Group 2: Dasatinib & Quercetin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Observational Group 2: Dasatinib & Quercetin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1: Observational Group 2: Dasatinib & Quercetin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: LaTonya J. Hickson, M.D.
Organization: Mayo Clinic
Phone: 507-284-3594
EMail: Hickson.Latonya@mayo.edu
Layout table for additonal information
Responsible Party: LaTonya J. Hickson, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02848131     History of Changes
Other Study ID Numbers: 15-005843
First Submitted: March 22, 2016
First Posted: July 28, 2016
Results First Submitted: June 4, 2019
Results First Posted: June 26, 2019
Last Update Posted: June 26, 2019