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Impact of Hemo-dialysis Therapy on Blood Levels of Treprostenil in End Stage Renal Disease Patients With Pulmonary Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01234571
First received: November 3, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

November 3, 2010
November 3, 2010
November 2010
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No Changes Posted
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Impact of Hemo-dialysis Therapy on Blood Levels of Treprostenil in End Stage Renal Disease Patients With Pulmonary Hypertension
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Remodulin (Treprostenil sodium) is synthetic prostacyclin analog available as a solution for administration in the intravenous route. It is approved for treatment of class I - pulmonary hypertension functional capacity stage III-IV. A key factor for the success of pulmonary hypertension therapy is maintaining near constant blood level of a given medications along the day. A sudden decrease in the blood levels might lead to rebound phenomenon; abrupt increase in the pulmonary artery pressure which might lead to acute right ventricular failure and even to sudden death. As some PHT patients suffer are on hemo-dialysis therapy due to end-stage renal disease there is a need to document the variation of the blood level along the dialysis cycle.

After giving informed consent 10 ml of blood will be drawn from the study population at the following occasions.

  • Baseline measurement immediately before starting HD therapy.
  • During the hemo-dialysis therapy - every one hour.
  • After the end of the hemo-dialysis therapy - every one hour (a total of four measurements) to record recovery of Treprostenil blood levels.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

The study population includes patients with PAH who receive chronic (more than 3 months) Treprostenil treatment administered intravenously as a single agent therapy who maintain chronic hemo-dialysis therapy. Patients must be in stable condition for at least one month. Patients other than class I PAH will be not included in this study.

  • Pulmonary Hypertension
  • End-Stage Renal Disease
  • Hemo-dialysis Therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
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Inclusion Criteria:patients with PAH who receive chronic (more than 3 months) Treprostenil treatment administered intravenously as a single agent therapy who maintain chronic hemo-dialysis therapy. Patients must be in stable condition for at least one month. Patients other than class I PAH will be not included in this study.

Exclusion Criteria:

  • none
Both
18 Years and older
No
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NCT01234571
0273-10CTIL
No
Dr. Mordechai Yigla, Rambam Health Care Campus
Rambam Health Care Campus
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Rambam Health Care Campus
October 2010

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