Pentoxifylline and Systemic Inflammation in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01269827
First received: January 3, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

January 3, 2011
January 3, 2011
January 2006
May 2008   (final data collection date for primary outcome measure)
serum levels of TNF-a, IL-6 and CRP [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Inflammation
  • End-stage Renal Disease
  • Hemodialysis
  • 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)
    Other Name: trental
  • 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
  • Experimental: pentoxifylline
    Intervention: Drug: Pentoxifylline
  • Placebo Comparator: placebo
    Intervention: Drug: starch tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥18 years,
  • ≥2 months on HD,
  • arteriovenous fistula as vascular access, and
  • endorsement of informed consent.

Exclusion Criteria:

  • inflammatory cause of ESRD,
  • liver disease, cancer, AIDS,
  • any infectious disease 2 months before the study,
  • failed kidney graft,
  • hypersensitivity to PTX or other methylxanthines,
  • hemorrhage/clotting disorders,
  • risk for worsening pre-existing cardiac arrhythmias or arterial hypotension,
  • treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins or PTX 3 months previous to the study
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01269827
2006-1A-I-007, other grant
Yes
Alfonso M. Cueto-Manzano, Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
Coordinación de Investigación en Salud, Mexico
Not Provided
Study Chair: Alfonso M. M Cueto-Manzano, MD, MSc, PhD Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
Coordinación de Investigación en Salud, Mexico
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP