Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypoalbuminemia, Protein-energy Malnutrition, Inflammation, Oxidative Stress, Chronic Kidney Disease (CKD) Hemodialysis

In brief

Study of efficiency and safety of oral nutritional supplements with anti-inflammatory and antioxidative properties combined with an appetite stimulant with anti-inflammatory properties (pentoxiphylline) in treatment of malnutrition-inflammation-cachexia syndrome in maintenance hemodialysis patients

Key facts

Study ID

NCT00561093

Run by

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

People needed

93

Starts

2008-02-01

Expected to finish

2011-05-01

Last updated by the study team

2015-05-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 3 months on maintenance hemodialysis,
• Last 3-month averaged serum albumin <4.0 g/dl,
• Average monthly Kt/V>1.2,
• Dialysis time between 3 and 5 hours,
• Functioning AV graft or fistula or tunnel catheter that will not switch for 6 months,
• Standardized dialysis treatment per DaVita protocol.
• In case the averaged 3-month is not <4.0 g/dl but last month serum albumin <4.0 g/dl (worsening hypoalbuminemia) patient will be qualified, if 3-month averaged nPNA < 0.8 g/kg/day or a BMI < 20 kg/m2.

You may not qualify if…

• Peritoneal dialysis
• Terminal illnesses with life expectancy<6 months
• Maintenance hemodialysis less than 5 months
• Concurrent appetite stimulants
• Use of IDPN in the past 2-3 months
• Inability to follow and to comply with the instructions and guidelines
• Likelihood of pregnancy or intention to become pregnant
• Acute wasting condition or active systemic disease
• Pulse chemo therapy
• Non-compliance with dialysis treatment
• Dialysis catheter that may switch soon.

Where it is running

• DaVita Nutrition Services — Irvine, California, United States
• Los Angeles Biomedical Research Institute (LABioMed) at Harbor-UCLA — Torrance, California, United States

Full record on ClinicalTrials.gov

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