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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 7, 2016
First Posted Date  ICMJE December 14, 2016
Results First Submitted Date  ICMJE March 21, 2019
Results First Posted Date  ICMJE August 9, 2019
Last Update Posted Date August 9, 2019
Study Start Date  ICMJE August 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
  • Renal Plasma Flow [ Time Frame: 0, 2h, 4h, 6h and 8 h after start of infusion ]
    Renal plasma flow measurement by para-Amino-Hippuric-Acid Clearance Method
  • Glomerular Filtration Rate [ Time Frame: 0, 2h, 4h, 6h and 8 h after start of infusion ]
    by para-Amino-Hippuric Acid Clearance Method
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2016)
  • Renal Plasma Flow [ Time Frame: 2 days ]
    Renal plasma flow measurement by PAH-Method
  • Glomerular Filtration Rate [ Time Frame: 2 days ]
    by PAH-Method
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
Serum Creatinine Concentration [ Time Frame: 0, 2h, 4h, 6h, 8h, 10h, 24h and 48h after start of infusion ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2016)
  • Filtration fraction [ Time Frame: 2 days ]
    Ratio glomerular filtration rate / renal plasma flow for p-aminohippuric acid
  • Mean brachial blood pressure [ Time Frame: 2 days ]
  • Serum Creatinine Concentration [ Time Frame: 2 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers
Official Title  ICMJE Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers
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.
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 Pharmacokinetic of VAS203 and its first metabolite.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Renal Function Impairment in Healthy Volunteers
Intervention  ICMJE
  • Drug: VAS203
    Infusion of NO-Synthase inhibitor VAS203
    Other Name: Ronopterin
  • Drug: Saline
    Infusion of saline
    Other Name: 0.9% sodium chloride
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Infusion (6 hours) of Saline
    Intervention: Drug: Saline
  • Active Comparator: VAS203
    Infusion (6 hours) of VAS203 (10 mg/kg)
    Intervention: Drug: VAS203
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2016)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Serum glutamate oxaloacetate transaminase or glutamate-pyruvate transaminase > 2-times above the upper limit of normal range.
  3. Subject with Cockcroft-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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02992236
Other Study ID Numbers  ICMJE VAS203/I/3/05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Vasopharm GmbH
Study Sponsor  ICMJE Vasopharm GmbH
Collaborators  ICMJE Winicker Norimed GmbH
Investigators  ICMJE
Principal Investigator: Roland E Schmieder, Prof. Dr. Universitätsklinik Erlangen
PRS Account Vasopharm GmbH
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP