NCT01269827

Pentoxifylline and Systemic Inflammation in Hemodialysis Patients

Randomized, Double-Blinded, Controlled Clinical Trial of the Effect Pentoxifylline vs Placebo on the Serum Concentrations of TNF-a, IL-6 and CRP of Patients in Hemodialysis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Coordinación de Investigación en Salud, Mexico · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to compare the effect of PTX vs placebo on serum concentrations of TNF-α, IL-6, and CRP in patients on hemodialysis.

Detailed description

Patients were randomly selected from the total HD patients of our hospital. Once included, patients were randomly allocated (by a computer-generated randomization list) to a study or control group. Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time), whereas controls received one starch identical tablet on the same schedule. All patients had three HD sessions per week, with the same kind of single-use dialysis membrane and dialysate. Monthly visits were scheduled for clinical and biochemical evaluations. A blood sample was taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). In serum samples at 0, 2 and 4 months, TNF-α and IL-6 concentrations were measured by ELISA using high sensitivity kits (Amersham Pharmacia Biotech, Buckinghamshire, UK). Additionally, in the same serum samples, CRP concentrations were measured by nephelometry using high sensitivity kits (Dade Behring, Marburg, Germany) in a Nephelometry Analyzer II (Dade Behring, Marburg, Germany). All laboratory measurements, including inflammation markers, were performed in the Central Laboratory (Hospital de Especialidades, CMNO), by the same personnel blinded to patient's details. Treatment compliance was recorded by counting tablets left in the container at the end of each monthly visit.

Conditions

• Inflammation
• End-stage Renal Disease
• Hemodialysis

Interventions

Type	Name	Description
DRUG	Pentoxifylline	Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time)
DRUG	starch tablets	Over a period of 4 months, patients of the control group received one starch tablet orally once a day (at dinner time)

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2011-01-04
• Last updated: 2018-12-19

Locations

1 site across 1 country: Mexico