NCT02992236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 14, 2016

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 9, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

December 7, 2016

Results QC Date

March 21, 2019

Last Update Submit

August 8, 2019

Conditions

Renal Function Impairment in Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Renal Plasma Flow

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

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

  • Glomerular Filtration Rate

    by para-Amino-Hippuric Acid Clearance Method

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

Secondary Outcomes (1)

  • Serum Creatinine Concentration

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Infusion (6 hours) of Saline

Drug: Saline

VAS203

ACTIVE COMPARATOR

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

Drug: VAS203

Interventions

VAS203DRUG

Infusion of NO-Synthase inhibitor VAS203

Also known as: Ronopterin
VAS203
SalineDRUG

Infusion of saline

Also known as: 0.9% sodium chloride
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent in writing available.
  • Willing and able to comply with all requirements of the study.
  • Male, 18 and 45 years (inclusive).
  • Subject has a body weight between 60 kg and 100 kg, extremes included.
  • BMI 18 to 27 kg/m2.
  • Non-smoker
  • Serum creatinine within reference range (≤1.2 mg/dL) and Cockroft-Gault Clearance \> 90 ml/min
  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik Erlangen

Erlangen, 91054, Germany

Location

MeSH Terms

Interventions

4-amino-tetrahydrobiopterinSodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Prof Dr Rroland Schmieder
Organization
Nephrology University Erlangen Germany
roland.schmieder@uk-erlangen.de
+49 9131 8536207

Study Officials

  • Roland E Schmieder, Prof. Dr.

    Universitätsklinik Erlangen

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 14, 2016

Study Start

August 1, 2015

Primary Completion

May 1, 2016

Study Completion

November 1, 2016

Last Updated

August 9, 2019

Results First Posted

August 9, 2019

Record last verified: 2019-08

Locations

DE(1)