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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
  Purpose

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
Inflammation
End-stage Renal Disease
Hemodialysis
 Drug: Pentoxifylline
Drug: starch tablets
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: México: Coordinación de Investigación en Salud, IMSS

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

Additional relevant MeSH terms:
Inflammation
Kidney Diseases
Kidney Failure, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on June 18, 2013