Pentoxifylline and Systemic Inflammation in Hemodialysis Patients
|Inflammation End-stage Renal Disease Hemodialysis||Drug: Pentoxifylline Drug: starch tablets||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- serum levels of TNF-a, IL-6 and CRP [ Time Frame: 4 months ]
|Study Start Date:||January 2006|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time)
Other Name: trental
|Placebo Comparator: placebo||
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)
Other Name: placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269827
|Hospital de Especialidades, CMNO, IMSS|
|Guadalajara, Jalisco, Mexico, 44320|
|Study Chair:||Alfonso M. M Cueto-Manzano, MD, MSc, PhD||Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS|