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The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

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ClinicalTrials.gov Identifier: NCT01131845
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : May 17, 2012
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Study Description
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Brief Summary:

This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (ESRD; on dialysis).

Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis.

Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with ESRD will have a sample taken at 60 hrs post dose.


Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Renal Dysfunction Drug: UT-15C SR (treprostinil diethanolamine) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment.
Study Start Date : May 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treprostinil diethanolamine Drug: UT-15C SR (treprostinil diethanolamine)
Single dose, 1 mg UT-15C SR


Outcome Measures
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Primary Outcome Measures :
  1. Treprostinil pharmacokinetics in volunteers with varying degrees of renal function following a single oral dose of a 1 mg treprostinil diethanolamine sustained release. [ Time Frame: 48hrs post dose (60 hours for ESRD) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Male and female volunteers with ESRD (requiring dialysis), moderate (creatinine clearance; CrCL = 30-50 mL/min), mild (CrCL = 50-80 mL/min) and normal renal function (control group; (CrCL >80 mL/min)) may be enrolled. Eligible subject will be 18-79 years of age with a BMI between 18 - 40 kg/m2 and not taking chronic nonsteroidal antiinflammatory drugs (NSAIDs)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131845


Locations
United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Sponsors and Collaborators
United Therapeutics
Investigators
Principal Investigator: Thomas Marbury, MD Orlando Clincal Reserach Center
More Information
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Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01131845     History of Changes
Other Study ID Numbers: TDE-PH-120
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
 Lung Diseases
Respiratory Tract Diseases
Kidney Diseases
Urologic Diseases
Treprostinil
Antihypertensive Agents