Lipid Infusion in Dialysis Patients With Endotoxemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Fatigue, End Stage Renal Disease (ESRD)

In brief

The purpose of this study is to determine whether a phospholipid emulsion is effective in the treatment of chronic endotoxemia in hemodialysis patients.

Key facts

Study ID

NCT00506454

Run by

Sepsicure

People needed

22

Starts

2007-08-01

Expected to finish

2008-02-01

Last updated by the study team

2011-09-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• On hemodialysis for ≥ 3 months.
• Provided written and dated informed consent.
• Meets the following lab parameters on Screening labs:
• Serum albumin > 2.5 g/dL;
• Serum total cholesterol > 95 mg/dL;
• Serum High-Density Lipoprotein (HDL) > 20 mg/dL;
• Serum hemoglobin ≥ 11 g/dL;
• Serum transaminases < 2x the upper limit of normal.
• Has had a dialysis adequacy level (KT/V) greater than 1.3 for 2 months prior to screening.
• Has a vitality score of ≤ 16 at time of screening.

You may not qualify if…

• Currently participating in or has participated in an investigational drug or medical device study within 30 days or five half-lives, whichever is longer, prior to enrollment in this study.
• Pregnant, breast-feeding or female of childbearing potential who does not agree to remain abstinent or to use an acceptable contraceptive regimen (oral contraceptive, double-barrier method, or abstention from sexual relations) during the study period.
• Has any of the following laboratory abnormalities when screened:
• Serum haptoglobin below the lower limit of normal;
• Lactate dehydrogenase (LDH) > 300 U/L;
• Low-Density Lipoprotein (LDL) > 190 mg/dL;
• Fasting (8 hours, water only) triglyceride level > 300 mg/dL;
• Serum phospholipid level > 500 mg/dL.
• Has an EAA level < 0.6 Endotoxin Activity (EA) at screening.
• Has prolonged heart wave (QT) interval (as defined by corrected QT (QTc) > 460 msec in males and > 470 msec in females) on screening electrocardiogram (ECG).
• Has a history of allergic reaction to eggs (or egg products), soybeans, Intralipid, or any component of "LIPIDOSE".
• Has had a recent hospitalization (within the last 30 days) or has other acute illness.
• Deemed not medically or psychiatrically stable for the study (in opinion of investigator or the subject's primary nephrologist).
• Currently on any of the following medications: (a) medications known to cause QT prolongation; (b) parenteral nutrition supplements (e.g., Intralipid); (c)amphotericin; (d) liposomal amphotericin; (e) amphotericin B lipid complex; or (f) coumadin.
• Has known preexisting systolic dysfunction (as defined by previous echocardiogram with ejection fraction (EF) < 35%).
• Currently receiving one of the following prohibited concomitant medications; parenteral nutrition supplements containing lipid "emulsion" (e.g., Intralipid), amphotericin, liposomal amphotericin, or amphotericin B lipid complex.
• Has a known active hemolytic disease; immune hemolytic anemias, hemoglobinopathies (sickle cell anemia and thalassemia major) or is known or believed to suffer from hereditary spherocytosis or S.E. Asian elliptocytosis.
• Has a known bone marrow disorder of inadequate red cell production (e.g., aplastic anemia, myelodysplasia).
• Has known current alcohol or drug abuse.

Where it is running

• Rogosin Manhattan Dialysis Center — New York, New York, United States

Full record on ClinicalTrials.gov

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