Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis

NCT01241539 | Completed Phase 1 Results

• 2 other identifiers: 1160.1212010-021819-16
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Diseases; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (3)

• Dialysis Clearance of Dabigatran

  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.

  4 hours

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

  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.

  4 hours

• Plasma Concentration Extraction Ratio

  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).

  4 hours

Secondary Outcomes (6)

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

  Days 2 and 3

• Maximum Plasma Concentrations of Dabigatran (Cmax)

  Days 2 and 3

• Time to Maximum Plasma Concentration (Tmax)

  Day 3

• Coagulation Parameters

  Day 3

• Safety and Tolerability

  2 periods of 5 days each

Study Arms (3)

Dabigatran etexilate 110 mg

EXPERIMENTAL

Capsule, oral

Drug: Dabigatran etexilate

Dabigatran etexilate 75 mg

EXPERIMENTAL

Capsule, oral

Drug: Dabigatran etexilate

Dabigatran etexilate 150 mg

EXPERIMENTAL

Capsule, oral

Drug: Dabigatran etexilate

Interventions

Dabigatran etexilate DRUG

150 mg capsule

Dabigatran etexilate 150 mg

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1160.121.1 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Kidney Failure, Chronic

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Last Updated: April 7, 2014
• Results First Posted: July 27, 2012

Record last verified: 2014-02

Locations

DE (1)