Lipid Infusion in Dialysis Patients With Endotoxemia
Condition: Fatigue; End Stage Renal Disease (ESRD)
MeSH terms: Endotoxemia; Kidney Failure, Chronic; Fatigue
Intervention: Lipidose; Placebo
Intervention description: Over the course of 2 weeks, immediately following subject's three (Monday/Wednesday/Friday (M/W/F)) normal dialysis treatments, based on subject's current weight, subject will receive 1.5 mL/kg of Lipidose over a 2-hour period.; Over the course of 2 weeks, immediately following subject's three (M/W/F) normal dialysis treatments, based on subject's current weight, subject will receive 1.5 mL/kg of placebo over a 2-hour period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fatigue; Hemodialysis; Endotoxemia; Phospholipid; Emulsion

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          1. On hemodialysis for ≥ 3 months.

          2. Provided written and dated informed consent.

          3. 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.

          4. Has had a dialysis adequacy level (KT/V) greater than 1.3 for 2 months prior to
             screening.

          5. Has a vitality score of ≤ 16 at time of screening.

        Exclusion Criteria:

          1. 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.

          2. 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.

          3. 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.

          4. Has an EAA level < 0.6 Endotoxin Activity (EA) at screening.

          5. 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).

          6. Has a history of allergic reaction to eggs (or egg products), soybeans, Intralipid, or
             any component of "LIPIDOSE".

          7. Has had a recent hospitalization (within the last 30 days) or has other acute illness.

          8. Deemed not medically or psychiatrically stable for the study (in opinion of
             investigator or the subject's primary nephrologist).

          9. 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.

         10. Has known preexisting systolic dysfunction (as defined by previous echocardiogram with
             ejection fraction (EF) < 35%).

         11. 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.

         12. 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.

         13. Has a known bone marrow disorder of inadequate red cell production (e.g., aplastic
             anemia, myelodysplasia).

         14. Has known current alcohol or drug abuse.