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Pentoxifylline and Systemic Inflammation in Hemodialysis Patients

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

Condition Intervention Phase
End-stage Renal Disease
Drug: Pentoxifylline
Drug: starch tablets
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • serum levels of TNF-a, IL-6 and CRP [ Time Frame: 4 months ]

Enrollment: 36
Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pentoxifylline 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
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

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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01269827

Hospital de Especialidades, CMNO, IMSS
Guadalajara, Jalisco, Mexico, 44320
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Study Chair: Alfonso M. M Cueto-Manzano, MD, MSc, PhD Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
  More Information

Responsible Party: Alfonso M. Cueto-Manzano, Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS Identifier: NCT01269827     History of Changes
Other Study ID Numbers: 2006-1A-I-007
other grant ( Other Grant/Funding Number: Fondo de Fomento a la Investigación (No. 2006-1A-I-007) )
Study First Received: January 3, 2011
Last Updated: January 3, 2011

Keywords provided by Coordinación de Investigación en Salud, Mexico:

Additional relevant MeSH terms:
Kidney Failure, Chronic
Pathologic Processes
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants processed this record on May 25, 2017