Trial Outcomes & Findings for Alpha-Adrenoceptor Vascular Function In Chronic Kidney Disease Focus On The Role Of Endothelial Nitric Oxide (NCT NCT00356265)

Last Updated: 2018-01-23

Results Overview

Vasoreactivity is defined as Forearm blood flow, dose response curve; ml per minute per log of phenylephrine, or FABF ml/min/logPE; The x axis is the ml/min value and the y axis is the log Phenylephrine concentration.

Recruitment status

TERMINATED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

up to 8 hours

Results posted on

2018-01-23

Participant Flow

Three screen failures

Participant milestones

Participant milestones
Measure	Chronic Kidney Disease (CKD) Procedure: Regional phenylephrine arterial infusion	Hypertension Group Procedure: Regional phenylephrine arterial infusion	Normotensive Group Procedure: Regional phenylephrine arterial infusion
Overall Study STARTED	7	2	6
Overall Study COMPLETED	7	2	5
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Chronic Kidney Disease (CKD) Procedure: Regional phenylephrine arterial infusion	Hypertension Group Procedure: Regional phenylephrine arterial infusion	Normotensive Group Procedure: Regional phenylephrine arterial infusion
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Alpha-Adrenoceptor Vascular Function In Chronic Kidney Disease Focus On The Role Of Endothelial Nitric Oxide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chronic Kidney Disease n=7 Participants Procedure: Regional phenylephrine arterial infusion	Hypertension Group n=2 Participants Procedure: Regional phenylephrine arterial infusion	Normotensive Group n=6 Participants Procedure: Regional phenylephrine arterial infusion	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	7 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants	15 participants n=4 Participants

PRIMARY outcome

Timeframe: up to 8 hours

Population: Based on the data from the 12 participants, and the early termination, no analysis was performed on the two hypertensive participants' data.

Outcome measures

Outcome measures
Measure	Chronic Kidney Disease n=7 Participants Procedure: Regional phenylephrine arterial infusion	Normotensive Group n=5 Participants	Normotensive Group Procedure: Regional phenylephrine arterial infusion
α1-adrenoceptor Vasoreactivity With L-NMMA before L-NMMA infusion	-0.48 ml/min x 1/log[PE] Standard Error 0.10	-0.22 ml/min x 1/log[PE] Standard Error 0.08	—
α1-adrenoceptor Vasoreactivity With L-NMMA after L-NMMA infusion	-0.31 ml/min x 1/log[PE] Standard Error 0.09	-0.16 ml/min x 1/log[PE] Standard Error 0.11	—

PRIMARY outcome

Timeframe: up to 8 hours

Population: The main goal of the study was to compare vasoreactivity across the three groups. Given the fact that we struggled to recruit matched hypertensive and normotensive control population, we were not able to achieve the goals of the study and therefore, ADMA levels were not measured.

Outcome measures

Outcome data not reported

Adverse Events

Chronic Kidney Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypertension Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normotensive Group

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

Crystal Gadegbeku

University of Michigan

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place