Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006452

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

To study the blood concentrations of POL7080 in subjects with impaired renal function.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006452
  •   2015/02/17
  •   2014/04/08
  •   no
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Secondary IDs

  •   NCT02110459  (ClinicalTrials.gov)
  •   POL7080-005  (Polyphor Ltd.)
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Health Condition or Problem studied

  •   Renal Impairment
  •   N18 -  Chronic kidney disease
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Interventions/Observational Groups

  •   Drug: POL7080
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Basic research/physiological study
  •   Parallel
  •   I
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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

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Secondary Outcome

- Adverse events; time frame: Daily assessment up to 7 days from informed consent; 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.
- Laboratory abnormalities; time frame: Screening, Day -1, Day 2, Day 3, and Day 7; The number and severity of blood chemistry and hematology findings will be summarized descriptively and compared to baseline.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2013/02/27
  •   40
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   79   Years
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Additional Inclusion Criteria

- 1. Subjects who signed informed consent.

- 2. Male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of
age of non-childbearing potential

- 3. Weight within a BMI range of 19.0-35.0 kg/m2.

- 4. CLCr according to Cockcroft Gault equation of:

- 50-80 mL/min (mild renal impairment)

- 30- <50 mL/min (moderate renal impairment)

- <30 mL/min (severe renal impairment)

- subjects receiving dialysis for ≥3 months before dosing (ESRD)

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Exclusion Criteria

- 1. Unwilling or unable to give informed consent.

- 2. As a result of the medical screening process, the study physician considers the
subject unfit for the study.

- 3. Demonstrating excess in xanthine consumption (more than 5 cups of coffee or
equivalent per day).

- 4. Subjects who smoke more than 10 cigarettes a day.

- 5. Subjects who consume more than 28 units (males) or more than 21 units (females) of
alcohol per week.

- 6. Any history of hypersensitivity to the IMP.

- 7. 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.

- 8. 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.

- 9. Participation in another clinical study with an investigational drug or device
within the last month.

- 10. Subjects with clinically significant telemetric ECG abnormalities on Day -1

- 11. Significant allergies requiring intranasal or systemic corticosteroids during any
time of the year or history of any anaphylactic reaction.

- 12. Positive test for human immunodeficiency virus (HIV) antibodies.

- 13. Acute Hepatitis B or C infection.

- 14. The subject has tested positive for drugs of abuse at screening.

- 15. 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).

- 16. Immunocompromised patients (patients after solid organ or bone marrow transplant;
patients receiving immunosuppressive treatment).

- 17. Subjects with known or suspected Pseudomonas infection or colonization (e.g.
patients with cystic fibrosis).

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Addresses

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    • Polyphor Ltd.
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    • CRS Clinical Research Services Kiel GmbH
    • Atef Halabi, MD 
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    • Klaus Dembowsky, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.