Trial Outcomes & Findings for Xanthine Oxidase Inhibition in Renal Transplant Recipients (NCT NCT01332799)

NCT ID: NCT01332799

Last Updated: 2019-10-15

Results Overview

Number of major cardiovascular events

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2019-10-15

Participant Flow

Participant milestones

Measure	Allopurinol allopurinol Daily active drug (allopurinol administered orally)	Placebo (Sugar Pill) Placebo: Daily placebo (sugar pill) administered orally for 3 years.
Overall Study STARTED	10	10
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	10	10

Reasons for withdrawal

Measure	Allopurinol allopurinol Daily active drug (allopurinol administered orally)	Placebo (Sugar Pill) Placebo: Daily placebo (sugar pill) administered orally for 3 years.
Overall Study Insufficient funding	10	10

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Allopurinol n=10 Participants allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.	Placebo (Sugar Pill) n=10 Participants allopurinol or placebo: Daily active drug (allopurinol administered orally) to be compared to daily placebo (sugar pill) administered orally for 3 years.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants	10 Participants n=10 Participants	20 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Sex: Female, Male Female	8 Participants n=10 Participants	8 Participants n=10 Participants	16 Participants n=20 Participants
Sex: Female, Male Male	2 Participants n=10 Participants	2 Participants n=10 Participants	4 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 3 years

Population: No intervention occurred, so no data was collected for report.

Number of major cardiovascular events

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 years

Population: No intervention occurred, so no data was collected for report.

Changes in flow-mediated dilatation of braquial artery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: No intervention occurred, so no data was collected for report.

Changes in pulse wave velocity.

Outcome measures

Outcome data not reported

Adverse Events

Allopurinol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (Sugar Pill)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Roberto Kalil

University of Iowa

Phone: 319-355-6564

Email: roberto-kalil@uiowa.edu

Results disclosure agreements

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