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

Study Description

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on renal function and perfusion in 16 healthy subjects.

Condition or disease	Intervention/treatment	Phase
Renal Function Impairment in Healthy Volunteers	Drug: VAS203; Drug: Saline	Phase 1

Detailed Description:

Analysis of the effect of i.v. VAS203 on renal function and perfusion in healthy subjects.

Primary objective:

Possible adverse effect of VAS203 on the Renal Plasma Flow (RPF) and the Glomerular Filtration Rate (GFR) during and after 6 hours of constant-rate iv. infusion of 10 mg/kg VAS203.

Secondary objective:

To analyse the effects of VAS203 on

• filtration fraction
• hemodynamics (afferent and efferent resistance, intraglomerular pressure)
• markers of kidney injury and renal function
• systolic, mean and diastolic brachial blood pressure
• Plasma PK of VAS203 and its first metabolite.

Study Design

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title:	Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers
Study Start Date :	August 2015
Actual Primary Completion Date :	May 2016
Actual Study Completion Date :	November 2016

Arms and Interventions

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Placebo; Infusion (6 hours) of Saline	Drug: Saline; Infusion of saline; Other Name: 0.9% sodium chloride
Active Comparator: VAS203; Infusion (6 hours) of VAS203 (10 mg/kg)	Drug: VAS203; Infusion of NO-Synthase inhibitor VAS203; Other Name: Ronopterin

Outcome Measures

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Renal plasma flow [ Time Frame: 2 days ]
   Renal plasma flow measurement by PAH-Method
2. Glomerular Filtration Rate [ Time Frame: 2 days ]
   by PAH-Method

Secondary Outcome Measures :

1. Filtration fraction [ Time Frame: 2 days ]
   Ratio glomerular filtration rate / renal plasma flow for p-aminohippuric acid
2. Mean brachial blood pressure [ Time Frame: 2 days ]
3. serum creatinine concentration [ Time Frame: 2 days ]

Eligibility Criteria

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1. Informed consent in writing available.
2. Willing and able to comply with all requirements of the study.
3. Male, 18 and 45 years (inclusive).
4. Subject has a body weight between 60 kg and 100 kg, extremes included.
5. BMI 18 to 27 kg/m2.
6. Non-smoker
7. Serum creatinine within reference range (≤1.2 mg/dL) and Cockroft-Gault Clearance > 90 ml/min
8. Good general health as judged by the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure and pulse rate) and clinical laboratory parameters (clinical chemistry, hematology, and urinalysis)

Exclusion Criteria:

1. Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgment).
2. S-GOT or S-GPT levels > 2-times above the upper limit of normal range.
3. Subject with Cockroft-Gault clearance < 90 ml/min.
4. Clinically significant history of cardiovascular disease or any known present cardiovascular disease.
5. History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
6. Office blood pressure at screening higher than 160/100 mmHg, or lower than 95/55 mmHg.
7. Office heart rate at screening after at least 5 minutes outside the range of 50- 99 beats per minute (inclusive).
8. Concomitant use of OTC medication within 1 week prior to dosing, except use of paracetamol (up to 2 g/day).
9. Participation in any other clinical study within 30 days prior to inclusion in this -

Contacts and Locations

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Universitätsklinik Erlangen
Erlangen, Germany, 91054

Sponsors and Collaborators

Vasopharm GmbH

Winicker Norimed GmbH

Investigators

Principal Investigator:	Roland E Schmieder, Prof. Dr.	Universitätsklinik Erlangen

More Information

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Vasopharm GmbH
ClinicalTrials.gov Identifier:	NCT02992236 History of Changes
Other Study ID Numbers:	VAS203/I/3/05
First Posted:	December 14, 2016
Last Update Posted:	December 14, 2016
Last Verified:	December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided