Trial Outcomes & Findings for Study of the Effect of Intradialytic Vasopressin on Chronic Hypertension in Patients With End Stage Renal Disease (NCT NCT01247090)

Last Updated: 2019-11-18

Results Overview

This is designed to measure if the administration of intradialytic AVP will result in change in systolic blood pressure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Baseline and Two Weeks

Results posted on

2019-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Very Low Dose Very Low Dose: Active Comparator 0.15 mU per kg per minute	Low Dose Low Dose: Active Comparator 0.30 mU per kg per minute	Placebo No Dose - Placebo Comparator
Overall Study STARTED	4	4	4
Overall Study COMPLETED	3	3	4
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Very Low Dose Very Low Dose: Active Comparator 0.15 mU per kg per minute	Low Dose Low Dose: Active Comparator 0.30 mU per kg per minute	Placebo No Dose - Placebo Comparator
Overall Study Physician Decision	1	0	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Study of the Effect of Intradialytic Vasopressin on Chronic Hypertension in Patients With End Stage Renal Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Very Low Dose n=4 Participants Very Low Dose: Active Comparator 0.15 mU per kg per minute	Low Dose n=4 Participants Low Dose: Active Comparator 0.30 mU per kg per minute	Placebo n=4 Participants No Dose - Placebo Comparator	Total n=12 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Age, Continuous	76.0 years STANDARD_DEVIATION 8.04 • n=5 Participants	71.0 years STANDARD_DEVIATION 8.98 • n=7 Participants	72.3 years STANDARD_DEVIATION 8.66 • n=5 Participants	73 years STANDARD_DEVIATION 8.1 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 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	1 Participants n=7 Participants	0 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	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	7 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	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	12 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Two Weeks

This is designed to measure if the administration of intradialytic AVP will result in change in systolic blood pressure.

Outcome measures

Outcome measures
Measure	Very Low Dose n=4 Participants Very Low Dose: Active Comparator 0.15 mU per kg per minute	Low Dose n=4 Participants Low Dose: Active Comparator 0.30 mU per kg per minute	Placebo n=4 Participants No Dose - Placebo Comparator
Change in Mean Interdialytic 44-hour Ambulatory Systolic Blood Pressure Over a 2 Week Follow-up Period	-1.5 mm Hg Standard Deviation 8.6	-3.7 mm Hg Standard Deviation 27.0	-0.4 mm Hg Standard Deviation 11.8

Adverse Events

Very Low Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Anjali Ganda, MD

Columbia University Medical Center

Phone: 617-835-3789

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place