Renal ImpairmentPhase 1NCT02110459

Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment

A Phase 1 study testing POL7080 in people with Renal Impairment, run by Polyphor Ltd. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function impairment after single intravenous (IV) infusion of POL7080 Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: POL7080
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteGermany
Study dates: Apr 2013to Jul 2015
Phase: Phase 1
Are there results?: None posted in the registry

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 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects who signed informed consent.
Male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of age of non-childbearing potential
Weight within a BMI range of 19.0-35.0 kg/m2.
CLCr according to Cockcroft Gault equation of:
50-80 mL/min (mild renal impairment)
30- <50 mL/min (moderate renal impairment)

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<30 mL/min (severe renal impairment)
subjects receiving dialysis for ≥3 months before dosing (ESRD)
>80 mL/min (normal renal function)

Who cannot join

Unwilling or unable to give informed consent.
As a result of the medical screening process, the study physician considers the subject unfit for the study.
Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day).
Subjects who smoke more than 10 cigarettes a day.
Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week.
Any history of hypersensitivity to the IMP.

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For subjects with renal impairment: No clinically significant change in disease status within at least 1 month prior to study entry, as determined by the investigator.
The subject had donated a unit of blood (450 mL) within the 3 months before dosing, or intends to donate in the month after the last scheduled visit.
Participation in another clinical study with an investigational drug or device within the last month.
Subjects with clinically significant telemetric ECG abnormalities on Day -1
Significant allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction.
Positive test for human immunodeficiency virus (HIV) antibodies.
Acute Hepatitis B or C infection.
The subject has tested positive for drugs of abuse at screening.
Subjects who have received any prescribed systemic or topical medication within 4 weeks prior to dosing (excluded are those drugs the renally impaired subject is currently taking for treatment of the renal or concomitant disease).
Immunocompromised patients (patients after solid organ or bone marrow transplant; patients receiving immunosuppressive treatment).
Subjects with known or suspected Pseudomonas infection or colonization (e.g. patients with cystic fibrosis).
Subjects with significant liver function abnormalities
Subjects with acute myocardial infection or unstable angina pectoris

Trial locations and contacts

1 site in 1 country.

Germany1 site

CRS Clinical Research Services Kiel GmbH
Kiel, 24105

Other trials in Germany

About this study

Official title: An Open-label, Non-randomized, Monocenter, Single-dose, Phase I Study to Evaluate Pharmacokinetics and Safety of POL7080 Administered as Single Intravenous Infusion to Subjects With Renal Impairment

To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function impairment after single intravenous (IV) infusion of POL7080

Conditions: Renal Impairment
Being tested: POL7080
Keywords: POL7080, Pharmacokinetics
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

POL7080Drug
Intravenous infusion

Study groups in NCT02110459
Study group	Role	What they receive
Mild renal impairment	Experimental	3h IV POL7080 infusion Receives: Drug: POL7080
Moderate renal impairment	Experimental	3h IV POL7080 infusion Receives: Drug: POL7080
Severe renal impairment	Experimental	3h IV POL7080 infusion Receives: Drug: POL7080
End stage renal disease arm 1	Experimental	3h IV POL7080 infusion Receives: Drug: POL7080
End stage renal disease arm 2	Experimental	3h IV POL7080 infusion Receives: Drug: POL7080
Normal Renal function	Experimental	3h IV POL7080 infusion Receives: Drug: POL7080

What is being measured

The primary outcome is the main question the study is designed to answer.

To measure the plasma concentrations of POL7080
Measured: at baseline, 0.5, 1,1.5 and 3 hours after start of infusion, at 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and 72 hours after end of infusion

Secondary outcomes (2)

Adverse events
Number of adverse events reported by the patients or observed by the investigator will be recorded. Onset, end date, severity, causal relationship, outcome and measures taken will be summarized. Discontinuations and serious adverse events will be listed and narrative summaries will be provided.
Measured: Daily assessment up to 7 days from informed consent
Laboratory abnormalities
The number and severity of blood chemistry and hematology findings will be summarized descriptively and compared to baseline.
Measured: Screening, Day -1, Day 2, Day 3, and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Jul 2015

First posted10 Apr 2014 (estimated)
Study startApr 2013
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal ImpairmentStudies 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: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02110459
Sponsor's protocol ID: POL7080-005
Status last verified: Jun 2016
First submitted: 8 Apr 2014
Last updated: 17 Jun 2016
Results posted: No
Data monitoring committee: No

Publications

Dale GE, Halabi A, Petersen-Sylla M, Wach A, Zwingelstein C. Pharmacokinetics, Tolerability, and Safety of Murepavadin, a Novel Antipseudomonal Antibiotic, in Subjects with Mild, Moderate, or Severe Renal Function Impairment. Antimicrob Agents Chemother. 2018 Aug 27;62(9):e00490-18. doi: 10.1128/AAC.00490-18. Print 2018 Sep.
PubMed 30012756

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Non-randomized, Monocenter, Single-dose, Phase I Study to Evaluate Pharmacokinetics and Safety of POL7080 Administered as Single Intravenous Infusion to Subjects With Renal Impairment
ClinicalTrials.gov ID: NCT02110459
Acronym / sponsor ID: POL7080-005
Conditions: Renal Impairment
Keywords: POL7080, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Polyphor Ltd.Industry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 10 Apr 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function impairment after single intravenous (IV) infusion of POL7080

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Mild renal impairment	Experimental	Drug: POL70803h IV POL7080 infusion
Moderate renal impairment	Experimental	Drug: POL70803h IV POL7080 infusion
Severe renal impairment	Experimental	Drug: POL70803h IV POL7080 infusion
End stage renal disease arm 1	Experimental	Drug: POL70803h IV POL7080 infusion
End stage renal disease arm 2	Experimental	Drug: POL70803h IV POL7080 infusion
Normal Renal function	Experimental	Drug: POL70803h IV POL7080 infusion

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Subjects who signed informed consent.
Male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of age of non-childbearing potential
Weight within a BMI range of 19.0-35.0 kg/m2.
CLCr according to Cockcroft Gault equation of:

Key exclusion criteria (19 listed)

Unwilling or unable to give informed consent.
As a result of the medical screening process, the study physician considers the subject unfit for the study.
Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day).
Subjects who smoke more than 10 cigarettes a day.
Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week.

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
POL7080Intravenous infusion	Drug	End stage renal disease arm 1, End stage renal disease arm 2, Mild renal impairment, Moderate renal impairment, Normal Renal function, Severe renal impairment

Primary outcome

To measure the plasma concentrations of POL7080
Time frame: at baseline, 0.5, 1,1.5 and 3 hours after start of infusion, at 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and 72 hours after end of infusion

2 secondary outcomes

Adverse events
Time frame: Daily assessment up to 7 days from informed consent
Laboratory abnormalities
Time frame: Screening, Day -1, Day 2, Day 3, and Day 7

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
Derived from this study: PubMed 30012756Dale GE, Halabi A, Petersen-Sylla M, Wach A, Zwingelstein C. Pharmacokinetics, Tolerability, and Safety of Murepavadin, a Novel Antipseudomonal Antibiotic, in Subjects with Mild, Moderate, or Severe Renal Function Impairment. Antimicrob Agents Chemother. 2018 Aug 27;62(9):e00490-18. doi: 10.1128/AAC.00490-18. Print 2018 Sep.

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

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.

Atef Halabi, MD principal investigator

CRS Clinical Research Services Kiel GmbH

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 POL7080 in people with Renal Impairment, run by Polyphor Ltd. 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 9 inclusion and 19 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 17 Jun 2016. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To measure the plasma concentrations of POL7080 (time frame: at baseline, 0.5, 1,1.5 and 3 hours after start of infusion, at 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and 72 hours after end of infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02110459, which also lists 1 linked publication.

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 17 Jun 2016.