The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01131845
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : May 17, 2012
Information provided by (Responsible Party):
United Therapeutics

May 10, 2010
May 27, 2010
May 17, 2012
May 2010
September 2010   (Final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT01131845 on Archive Site
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The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment.

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.

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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pulmonary Arterial Hypertension
  • Renal Dysfunction
Drug: UT-15C SR (treprostinil diethanolamine)
Single dose, 1 mg UT-15C SR
Experimental: Treprostinil diethanolamine
Intervention: Drug: UT-15C SR (treprostinil diethanolamine)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2010
September 2010   (Final data collection date for primary outcome measure)
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)
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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United Therapeutics
United Therapeutics
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Principal Investigator: Thomas Marbury, MD Orlando Clincal Reserach Center
United Therapeutics
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP