Lipid Infusion in Dialysis Patients With Endotoxemia

NCT00506454 | Completed Phase 2 Results DMC

• 1 other identifier: S201
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatigue; End Stage Renal Disease (ESRD)

Keywords

Fatigue; Hemodialysis; Endotoxemia; Phospholipid; Emulsion

Outcome Measures

Primary Outcomes (1)

• Reduction in Endotoxin Levels.

  The number of participants whose post-hemodialysis endotoxin (as measured by Endotoxin Activity Assay (EAA)) was less than their pre-hemodialysis endotoxin.

  Baseline and at 4 weeks

Study Arms (2)

Lipidose

ACTIVE COMPARATOR

Dosage of 1.5 mL/kg of Lipidose over a 2-hour period.

Drug: Lipidose

Placebo

PLACEBO COMPARATOR

Dosage of 1.5 mL/kg of Placebo over a 2-hour period.

Drug: Placebo

Interventions

Lipidose DRUG

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.

Also known as: GR270773

Lipidose

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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%).

Sponsors & Collaborators

• Sepsicure: lead
• The Rogosin Institute: collaborator

Study Sites (1)

Rogosin Manhattan Dialysis Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Fatigue; Kidney Failure, Chronic; Endotoxemia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation

Limitations and Caveats

There was no significant difference between endotoxin activity assay values in the active versus placebo recipients in this study.

Results Point of Contact

• Title: Vice President
• Organization: Sepsicure L.L.C.

bianuale@metromediacompany.com

212-606-4352

Study Officials

• Roxana Bologa, MD

  The Rogosin Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: August 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 20, 2011
• Results First Posted: August 15, 2011

Record last verified: 2011-09

Locations

US (1)