CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 93 enrolled
Drug / intervention
pentoxiphylline +5 moredrug
Likely dose
pentoxiphylline 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00561093
NCT00561093Phase 3Completed
CompareCT.gov

Pilot/Feasibility Randomized Control Trial to Examine the Effect of Oral Nutritional Supplements With Anti-inflammatory/Anti-oxidative Properties and Pentoxiphylline on Malnutrition-inflammation-cachexia Syndrome in Maintenance Hemodialysis Patients

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·interventional·Posted Nov 20, 2007·Updated May 21, 2015

In Brief

A Phase 3 clinical trial evaluating pentoxiphylline, Nepro, and 4 other interventions for Hypoalbuminemia and 4 related conditions. Completed, enrolled 93 participants across 2 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoalbuminemia, Protein-energy Malnutrition, Inflammation, Oxidative Stress, Chronic Kidney Disease (CKD) Hemodialysis
CountriesUnited States
CollaboratorsDaVita, Inc., Abbott Nutrition

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 20, 2007
Enrollment StartFeb 1, 2008
Primary CompletionOct 1, 2010
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.6 years ago

Interventions

pentoxiphyllinedrug

pentoxiphylline 400 mg daily, anti-inflammatory and appetite-stimulating while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

Neprodietary

Nepro (8 ounces) one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

anti-inflammatory module (similar to Oxepa)dietary

Oxepa-similar anti-inflammatory module (2 ounces) while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

Placebo pill imitating pentoxiphyllinedrug

Placebo pill imitating pentoxiphylline 400 mg daily, to imitate the anti-inflammatory and appetite-stimulating pill while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

Placebo to imitate Neprodietary

Placebo to imitate Nepro (8 ounces), with less protein and calorie, one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

Placebo to imitate anti-inflammatory module (similar to Oxepa)dietary

Placebo to imitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingredients, while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)