Trial Outcomes & Findings for Uric Acid and the Endothelium in CKD (NCT NCT01228903)

NCT ID: NCT01228903

Last Updated: 2017-06-28

Results Overview

Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2017-06-28

Participant Flow

Participant milestones

Measure	Control Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. Placebo: Placebo tablets with no active ingredient	Allopurinol Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group. Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels.
Overall Study STARTED	41	39
Overall Study COMPLETED	36	34
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Uric Acid and the Endothelium in CKD

Baseline characteristics by cohort

Measure	Control n=41 Participants Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. Placebo: Placebo tablets with no active ingredient	Allopurinol n=39 Participants Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group. Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels.	Total n=80 Participants Total of all reporting groups
Age, Continuous	58.9 years STANDARD_DEVIATION 9.3 • n=93 Participants	55.9 years STANDARD_DEVIATION 13.7 • n=4 Participants	57.4 years STANDARD_DEVIATION 11.5 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	7 Participants n=4 Participants	16 Participants n=27 Participants
Sex: Female, Male Male	32 Participants n=93 Participants	32 Participants n=4 Participants	64 Participants n=27 Participants
Region of Enrollment United States	41 participants n=93 Participants	39 participants n=4 Participants	80 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12

Outcome measures

Measure	Control n=41 Participants Placebo: Placebo tablets with no active ingredient	Allopurinol n=39 Participants Allopurinol: Xanthine oxidase inhibitor
Change in Endothelial Dependent Dilation From Baseline to Week 12	0.2 % change Standard Deviation 4.1	0.9 % change Standard Deviation 3.9

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Outcome measures

Measure	Control n=41 Participants Placebo: Placebo tablets with no active ingredient	Allopurinol n=39 Participants Allopurinol: Xanthine oxidase inhibitor
Change in C-reactive Protein From Baseline to Week 12	0.7 mg/L Standard Deviation 3.4	00.42 mg/L Standard Deviation 9.5

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Outcome measures

Measure	Control n=41 Participants Placebo: Placebo tablets with no active ingredient	Allopurinol n=39 Participants Allopurinol: Xanthine oxidase inhibitor
Change in Serum Interleukin-6 From Baseline to Week 12	0.15 pg/mL Standard Deviation 3.1	0.37 pg/mL Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: -4.7

Outcome measures

Measure	Control n=41 Participants Placebo: Placebo tablets with no active ingredient	Allopurinol n=39 Participants Allopurinol: Xanthine oxidase inhibitor
Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12	-4.7 pg/mL Standard Deviation 45.8	3.6 pg/mL Standard Deviation 36.7

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Outcome measures

Measure	Control n=41 Participants Placebo: Placebo tablets with no active ingredient	Allopurinol n=39 Participants Allopurinol: Xanthine oxidase inhibitor
Change in Oxidized Low Density Lipoprotein From Baseline to Week 12	-0.08 u/L Standard Deviation 11.8	-2.97 u/L Standard Deviation 16.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 weeks

Serum uric acid levels were measured both at baseline and after 12 weeks

Outcome measures

Measure	Control n=41 Participants Placebo: Placebo tablets with no active ingredient	Allopurinol n=39 Participants Allopurinol: Xanthine oxidase inhibitor
Change in Serum Uric Acid Levels From Baseline to Week 12	0.05 mg/dL Standard Deviation 1.54	3.24 mg/dL Standard Deviation 1.35

Adverse Events

Control

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Allopurinol

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control n=41 participants at risk Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. Placebo: Placebo tablets with no active ingredient	Allopurinol n=39 participants at risk Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group. Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels.
Cardiac disorders Death	0.00% 0/41	2.6% 1/39 • Number of events 1

Other adverse events

Measure	Control n=41 participants at risk Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. Placebo: Placebo tablets with no active ingredient	Allopurinol n=39 participants at risk Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group. Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels.
Musculoskeletal and connective tissue disorders gout	2.4% 1/41	2.6% 1/39
Gastrointestinal disorders GI discomfort	4.9% 2/41	5.1% 2/39
Skin and subcutaneous tissue disorders rash	4.9% 2/41	0.00% 0/39
Hepatobiliary disorders Abnormal Liver Function Tests	4.9% 2/41	0.00% 0/39
Blood and lymphatic system disorders Thrombocytopenia	4.9% 2/41	2.6% 1/39

Additional Information

Diana Jalal

University of Colorado

Phone: 3037244867

Email: diana.jalal@ucdenver.edu

Results disclosure agreements

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