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

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ClinicalTrials.gov Identifier: NCT02992236
Recruitment Status : Completed
First Posted : December 14, 2016
Results First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Winicker Norimed GmbH
Information provided by (Responsible Party):
Vasopharm GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Renal Function Impairment in Healthy Volunteers
Interventions Drug: VAS203
Drug: Saline
Enrollment 16
Recruitment Details  
Pre-assignment Details Cross-over design, all subjects received VAS203 and placebo
Arm/Group Title Placebo, Then VAS203 VAS203, Then Placebo
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title Placebo, Then VAS203 VAS203, Then Placebo Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
16
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
31.2  (7.9) 31.2  (7.9) 31.2  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
8
 100.0%
16
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 8 participants 8 participants 16 participants
8 8 16
1.Primary Outcome
Title Renal Plasma Flow
Hide Description Renal plasma flow measurement by para-Amino-Hippuric-Acid Clearance Method
Time Frame 0, 2h, 4h, 6h and 8 h after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo VAS203
Hide Arm/Group Description:

Infusion (6 hours) of Saline

Saline: Infusion of saline

Infusion (6 hours) of VAS203 (10 mg/kg)

VAS203: Infusion of NO-Synthase inhibitor VAS203

Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mL/min
541  (85) 663  (125)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, VAS203
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Glomerular Filtration Rate
Hide Description by para-Amino-Hippuric Acid Clearance Method
Time Frame 0, 2h, 4h, 6h and 8 h after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VAS203 Placebo
Hide Arm/Group Description:
Six hours infusion of 10 mg/kg VAS203.
Six hours Infusion of Saline
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mL/min
135  (15) 153.5  (15)
3.Secondary Outcome
Title Serum Creatinine Concentration
Hide Description [Not Specified]
Time Frame 0, 2h, 4h, 6h, 8h, 10h, 24h and 48h after start of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo VAS203
Hide Arm/Group Description:

Infusion (6 hours) of Saline

Saline: Infusion of saline

Infusion (6 hours) of VAS203 (10 mg/kg)

VAS203: Infusion of NO-Synthase inhibitor VAS203

Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.91  (0.1) 0.94  (0.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo VAS203
Hide Arm/Group Description

Infusion (6 hours) of Saline

Saline: Infusion of saline

Infusion (6 hours) of VAS203 (10 mg/kg)

VAS203: Infusion of NO-Synthase inhibitor VAS203

All-Cause Mortality
Placebo VAS203
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
Placebo VAS203
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo VAS203
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      5/16 (31.25%)    
Nervous system disorders     
Headache   1/16 (6.25%)  1 5/16 (31.25%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof Dr Rroland Schmieder
Organization: Nephrology University Erlangen Germany
Phone: +49 9131 8536207
EMail: roland.schmieder@uk-erlangen.de
Layout table for additonal information
Responsible Party: Vasopharm GmbH
ClinicalTrials.gov Identifier: NCT02992236    
Other Study ID Numbers: VAS203/I/3/05
First Submitted: December 7, 2016
First Posted: December 14, 2016
Results First Submitted: March 21, 2019
Results First Posted: August 9, 2019
Last Update Posted: August 9, 2019