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Trial record 3 of 3 for:    vasopharm

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
Last Update Posted : December 14, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

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
Primary Completion Date : May 2016
Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Arms and Interventions

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992236


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

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