Trial Outcomes & Findings for Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease (NCT NCT01350388)

NCT ID: NCT01350388

Last Updated: 2016-10-03

Results Overview

The percent difference in thiobarbituric acid reactive substance (TBARS) concentration geometric mean values from baseline to 24 weeks was calculated for each arm

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: Baseline and 24 weeks
• Results posted on: 2016-10-03

Participant Flow

Participant milestones

Measure	Febuxostat Febuxostat: 80 mg/day of febuxostat for 24 weeks	Placebo Placebo: 1 placebo tablet per day for 24 weeks
Overall Study STARTED	40	40
Overall Study COMPLETED	37	39
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Febuxostat on Adipokines and Kidney Disease in Diabetic Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Febuxostat n=40 Participants Febuxostat: 80 mg/day of febuxostat for 24 weeks	Placebo n=40 Participants Placebo: 1 placebo tablet per day for 24 weeks	Total n=80 Participants Total of all reporting groups
Estimated Glomerular Filtration Rate (eGFR)	52.2 milliliters per minute STANDARD_DEVIATION 15.3 • n=5 Participants	54.8 milliliters per minute STANDARD_DEVIATION 19.0 • n=7 Participants	53.5 milliliters per minute STANDARD_DEVIATION 17.2 • n=5 Participants
Age, Continuous	67 years STANDARD_DEVIATION 10 • n=5 Participants	68 years STANDARD_DEVIATION 11 • n=7 Participants	68 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Plasma Uric Acid Level	7.2 milligram per deciliter STANDARD_DEVIATION 1.5 • n=5 Participants	7.1 milligram per deciliter STANDARD_DEVIATION 1.2 • n=7 Participants	7.2 milligram per deciliter STANDARD_DEVIATION 1.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 weeks

The percent difference in thiobarbituric acid reactive substance (TBARS) concentration geometric mean values from baseline to 24 weeks was calculated for each arm

Outcome measures

Measure	Febuxostat n=37 Participants Febuxostat: 80 mg/day of febuxostat for 24 weeks	Placebo n=39 Participants Placebo: 1 placebo tablet per day for 24 weeks
Change in Thiobarbituric Acid Reactive Substance (TBARS) Concentration in Adipose Tissue From Baseline to 24 Weeks	34.0 percent difference in geometric mean Interval -26.3 to 143.4	44.6 percent difference in geometric mean Interval -19.3 to 159.2

PRIMARY outcome

Timeframe: Baseline and 24 weeks

The percent difference in adiponectin concentration geometric mean values from baseline to 24 weeks was calculated for each arm

Outcome measures

Measure	Febuxostat n=37 Participants Febuxostat: 80 mg/day of febuxostat for 24 weeks	Placebo n=39 Participants Placebo: 1 placebo tablet per day for 24 weeks
Change in Adiponectin Concentration in Adipose Tissue From Baseline to 24 Weeks	2.3 percent difference in geometric mean Interval -23.4 to 36.7	-4.1 percent difference in geometric mean Interval -27.7 to 27.4

PRIMARY outcome

Timeframe: Baseline and 24 weeks

The percent difference in TGF-beta1 concentration geometric mean values from baseline to 24 weeks was calculated for each arm

Outcome measures

Measure	Febuxostat n=37 Participants Febuxostat: 80 mg/day of febuxostat for 24 weeks	Placebo n=39 Participants Placebo: 1 placebo tablet per day for 24 weeks
Change in Urinary Concentrations of Transforming Growth Factor-beta1 (TGF-beta1) From Baseline to 24 Weeks	29.8 percent difference in geometric mean Interval 4.4 to 61.5	10.0 percent difference in geometric mean Interval -10.8 to 35.6

SECONDARY outcome

Timeframe: Baseline and 24 weeks

The percent difference in plasma TNF-α concentration geometric mean values from baseline to 24 weeks was calculated for each arm

Outcome measures

Measure	Febuxostat n=37 Participants Febuxostat: 80 mg/day of febuxostat for 24 weeks	Placebo n=39 Participants Placebo: 1 placebo tablet per day for 24 weeks
Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 24 Weeks	-9.9 percent difference in geometric mean Interval -30.6 to 16.8	-7.4 percent difference in geometric mean Interval -28.3 to 19.7

SECONDARY outcome

Timeframe: Baseline and 24 weeks

The percent difference in plasma IL-6 concentration geometric mean values from baseline to 24 weeks was calculated for each arm

Outcome measures

Measure	Febuxostat n=37 Participants Febuxostat: 80 mg/day of febuxostat for 24 weeks	Placebo n=39 Participants Placebo: 1 placebo tablet per day for 24 weeks
Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 24 Weeks	-24.0 percent difference in geometric mean Interval -35.3 to -10.7	-9.5 percent difference in geometric mean Interval -22.7 to 6.1

SECONDARY outcome

Timeframe: Baseline and 24 weeks

The percent difference in plasma hsCRP concentration geometric mean values from baseline to 24 weeks was calculated for each arm

Outcome measures

Measure	Febuxostat n=37 Participants Febuxostat: 80 mg/day of febuxostat for 24 weeks	Placebo n=39 Participants Placebo: 1 placebo tablet per day for 24 weeks
Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 24 Weeks	12.2 percent difference in geometric mean Interval -16.3 to 50.3	-7.2 percent difference in geometric mean Interval -30.5 to 23.8

Adverse Events

Febuxostat

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Febuxostat n=40 participants at risk Febuxostat: 80 mg/day of febuxostat for 24 weeks	Placebo n=40 participants at risk Placebo: 1 placebo tablet per day for 24 weeks
Hepatobiliary disorders Cholecystitis	0.00% 0/40 • 24 Weeks Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through week 24.	2.5% 1/40 • Number of events 1 • 24 Weeks Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through week 24.
Nervous system disorders Ischemic Stroke	0.00% 0/40 • 24 Weeks Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through week 24.	2.5% 1/40 • Number of events 1 • 24 Weeks Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through week 24.
General disorders Flu-like Symptoms	0.00% 0/40 • 24 Weeks Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through week 24.	2.5% 1/40 • Number of events 1 • 24 Weeks Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through week 24.
Cardiac disorders Atrial Fibrillation	0.00% 0/40 • 24 Weeks Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through week 24.	2.5% 1/40 • Number of events 1 • 24 Weeks Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through week 24.
Cardiac disorders Aortic Valve Disease	2.5% 1/40 • Number of events 1 • 24 Weeks Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through week 24.	0.00% 0/40 • 24 Weeks Details of adverse events experienced, particularly hospitalizations and emergency department visits obtained at each scheduled follow-up visit through week 24.

Other adverse events

Adverse event data not reported

Additional Information

Srinivasan Beddhu, M.D.

University of Utah

Phone: 801-585-3810

Email: srinivansan.beddhu@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place