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Pentoxifylline and Systemic Inflammation in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT01269827
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : January 4, 2011
Sponsor:
Information provided by:
Coordinación de Investigación en Salud, Mexico

Brief 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.

Condition or disease Intervention/treatment Phase
Inflammation End-stage Renal Disease Hemodialysis Drug: Pentoxifylline Drug: starch tablets Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : January 2006
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269827


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

Responsible Party: Alfonso M. Cueto-Manzano, Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
ClinicalTrials.gov 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) )
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: January 4, 2011
Last Verified: January 2011

Keywords provided by Coordinación de Investigación en Salud, Mexico:
inflammation
pentoxifylline
hemodialysis

Additional relevant MeSH terms:
Inflammation
Kidney Failure, Chronic
Pathologic Processes
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pentoxifylline
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