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. |
ClinicalTrials.gov Identifier: NCT01131845 |
Recruitment Status
:
Completed
First Posted
: May 27, 2010
Last Update Posted
: May 17, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 79 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |

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
United States, Florida | |
Orlando Clinical Research Center | |
Orlando, Florida, United States, 32809 |
Principal Investigator: | Thomas Marbury, MD | Orlando Clincal Reserach Center |
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 |