Renal Function Impairment in Healthy VolunteersPhase 1NCT02992236
Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers
A Phase 1 study testing VAS203 and Saline in people with Renal Function Impairment in Healthy Volunteers, run by veriNOS operations GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Renal Function Impairment in Healthy Volunteers
- What is being tested?
- VAS203 and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Nov 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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).
- Participation in any other clinical study within 30 days prior to inclusion in this -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- VAS203, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAS203Drug
Also called Ronopterin
Infusion of NO-Synthase inhibitor VAS203
SalineDrug
Also called 0.9% sodium chloride
Infusion of saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Infusion (6 hours) of Saline Receives: Drug: Saline |
| VAS203 | Active comparator | Infusion (6 hours) of VAS203 (10 mg/kg) Receives: Drug: VAS203 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Plasma Flow
Renal plasma flow measurement by para-Amino-Hippuric-Acid Clearance Method
Measured: 0, 2h, 4h, 6h and 8 h after start of infusion
Glomerular Filtration Rate
by para-Amino-Hippuric Acid Clearance Method
Measured: 0, 2h, 4h, 6h and 8 h after start of infusion
Secondary outcomes (1)
Serum Creatinine Concentration
Measured: 0, 2h, 4h, 6h, 8h, 10h, 24h and 48h after start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Function Impairment in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- veriNOS operations GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Responsible party
- Sponsor
- Investigators
- Roland E Schmieder, Prof. Dr., Principal investigator, Universitätsklinik Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992236
- Sponsor's protocol ID
- VAS203/I/3/05
- Status last verified
- Aug 2019
- First submitted
- 7 Dec 2016
- Last updated
- 9 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02992236
- Acronym / sponsor ID
- VAS203/I/3/05
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- veriNOS operations GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Posted 9 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalineInfusion (6 hours) of Saline |
| VAS203 | Active comparator | Drug: VAS203Infusion (6 hours) of VAS203 (10 mg/kg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAS203Also: RonopterinInfusion of NO-Synthase inhibitor VAS203 | Drug | VAS203 |
| SalineAlso: 0.9% sodium chlorideInfusion of saline | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Serum Creatinine Concentration
Time frame: 0, 2h, 4h, 6h, 8h, 10h, 24h and 48h after start of infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland E Schmieder, Prof. Dr. principal investigator
Universitätsklinik Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VAS203 and Saline in people with Renal Function Impairment in Healthy Volunteers, run by veriNOS operations GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Plasma Flow (time frame: 0, 2h, 4h, 6h and 8 h after start of infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.