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Completed

NCT Number: NCT01241539

Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis

The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.

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Key information

Conditions

Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1160.121.1 Boehringer Ingelheim Investigational Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • End stage renally disease (ESRD), undergoing haemodialysis
  • ESRD patients in relatively good health
  • Age 21 - 60 years inclusive
  • Signed and dated written informed consent prior to admission to the study

Exclusion criteria

  • Clinically relevant laboratory or physical examination abnormalities (except for renal function tests or deviation of clinical laboratory values) that are related to renal impairment
  • Moderate and severe concurrent liver function impairment
  • Surgery of gastrointestinal tract (except appendectomy or herniotomy) or evidence of significant gastrointestinal motility problems
  • Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding
  • Intake of medication, which influences the blood clotting
  • Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
  • For women with childbearing potential: no reliable contraception
  • Participation in another trial with an investigational drug (<2 months prior to administration or during trial)
  • Scheduled to receive a donor kidney transplant during the course of the study

Treatment and study plan

Dabigatran Etexilate

Drug

150 mg capsule

Primary outcomes

  1. Dialysis Clearance of Dabigatran

    Time frame: 4 hours

    Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma.

  2. Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis

    Time frame: 4 hours

    Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage.

  3. Plasma Concentration Extraction Ratio

    Time frame: 4 hours

    Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction).

Secondary outcomes

  1. Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)

    Time frame: Days 2 and 3

    Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran.

  2. Maximum Plasma Concentrations of Dabigatran (Cmax)

    Time frame: Days 2 and 3

    Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran.

  3. Time to Maximum Plasma Concentration (Tmax)

    Time frame: Day 3

    Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran.

  4. Coagulation Parameters

    Time frame: Day 3

    Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds.

  5. Safety and Tolerability

    Time frame: 2 periods of 5 days each

    Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment.

  6. Additional Safety Parameters

    Time frame: 2 periods of 5 days each

    By study design abnormalities could be due to dialysis or Dabigatran.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Open Label, Non Randomized, Multiple Dose Phase I Study to Investigate the Elimination, Pharmacokinetics, Pharmacodynamics and Safety of Dabigatran Etexilate (Pradaxa) Under Steady State Conditions Before, During and After Haemodialysis in Patients With End Stage Renal Disease (ESRD) Undergoing Regular Haemodialysis

Important dates

Study start
2010
Primary completion
2011
First posted
Nov 16, 2010
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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