Trial Outcomes & Findings for Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers (NCT NCT02992236)

NCT ID: NCT02992236

Last Updated: 2019-08-09

Results Overview

Renal plasma flow measurement by para-Amino-Hippuric-Acid Clearance Method

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: 0, 2h, 4h, 6h and 8 h after start of infusion
• Results posted on: 2019-08-09

Participant Flow

Cross-over design, all subjects received VAS203 and placebo

Participant milestones

Measure	Placebo, Then VAS203 Participants first received Placebo (6 hours Infusion of Saline). After a washout period of 4 weeks, they then received VAS203 (6 hours Infusion of 10 mg/kg VAS203).	VAS203, Then Placebo Participants first received VAS203 (6 hours Infusion of 10 mg/kg VAS203). After a washout period of 4 weeks, they then received Placebo (6 hours Infusion of Saline).
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers

Baseline characteristics by cohort

Measure	Placebo, Then VAS203 n=8 Participants Participants first received Placebo (6 hours Infusion of Saline). After a washout period of 4 weeks, they then received VAS203 (6 hours Infusion of 10 mg/kg VAS203).	VAS203, Then Placebo n=8 Participants Participants first received VAS203 (6 hours Infusion of 10 mg/kg VAS203). After a washout period of 4 weeks, they then received Placebo (6 hours Infusion of Saline).	Total n=16 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
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.2 years STANDARD_DEVIATION 7.9 • n=5 Participants	31.2 years STANDARD_DEVIATION 7.9 • n=7 Participants	31.2 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Germany	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 2h, 4h, 6h and 8 h after start of infusion

Renal plasma flow measurement by para-Amino-Hippuric-Acid Clearance Method

Outcome measures

Measure	Placebo n=16 Participants Infusion (6 hours) of Saline Saline: Infusion of saline	VAS203 n=16 Participants Infusion (6 hours) of VAS203 (10 mg/kg) VAS203: Infusion of NO-Synthase inhibitor VAS203
Renal Plasma Flow	541 mL/min Standard Deviation 85	663 mL/min Standard Deviation 125

PRIMARY outcome

Timeframe: 0, 2h, 4h, 6h and 8 h after start of infusion

by para-Amino-Hippuric Acid Clearance Method

Outcome measures

Measure	Placebo n=16 Participants Infusion (6 hours) of Saline Saline: Infusion of saline	VAS203 n=16 Participants Infusion (6 hours) of VAS203 (10 mg/kg) VAS203: Infusion of NO-Synthase inhibitor VAS203
Glomerular Filtration Rate	135 mL/min Standard Deviation 15	153.5 mL/min Standard Deviation 15

SECONDARY outcome

Timeframe: 0, 2h, 4h, 6h, 8h, 10h, 24h and 48h after start of infusion

Outcome measures

Measure	Placebo n=16 Participants Infusion (6 hours) of Saline Saline: Infusion of saline	VAS203 n=16 Participants Infusion (6 hours) of VAS203 (10 mg/kg) VAS203: Infusion of NO-Synthase inhibitor VAS203
Serum Creatinine Concentration	0.91 mg/dL Standard Deviation 0.1	0.94 mg/dL Standard Deviation 0.1

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

VAS203

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=16 participants at risk Infusion (6 hours) of Saline Saline: Infusion of saline	VAS203 n=16 participants at risk Infusion (6 hours) of VAS203 (10 mg/kg) VAS203: Infusion of NO-Synthase inhibitor VAS203
Nervous system disorders Headache	6.2% 1/16 • Number of events 1	31.2% 5/16 • Number of events 7

Additional Information

Prof Dr Rroland Schmieder

Nephrology University Erlangen Germany

Phone: +49 9131 8536207

Email: roland.schmieder@uk-erlangen.de

Results disclosure agreements

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