Phase 2 Completed N=16 Randomized Quadruple-blind Treatment

Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis

End Stage Renal Failure on Dialysis · Complication of Hemodialysis

Source: ClinicalTrials.gov NCT00732069 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Jun 2013

Primary outcomePrimary: Interleukin 1 Beta — 6.18; 2.16; 1.44 pg/mL

Summary

Little is known about how some drugs affect inflammation or clotting factors in people receiving hemodialysis. It is not yet known if these drugs help prevent heart damage as they do in people not undergoing hemodialysis or whether they could increase the risk of heart problems. The purpose of the study is to measure certain chemicals in the blood and see how those chemicals may change during hemodialysis when certain drugs are given.

Outcome Measures

Outcome	Result	p-value
PRIMARY Interleukin 1 Beta	6.18; 2.16; 1.44	—
SECONDARY F2-Isoprostanes	59.55; 59.03; 50.23	—

Eligibility Criteria

Inclusion Criteria

Age 18 years or older
On thrice-weekly chronic hemodialysis for at least 6 months
Clinically stable, adequately dialyzed (single-pool Kt/V> 1.2) thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study

Exclusion Criteria

Body mass index > 35 mg/kg
History of functional transplant less than 6 months prior to study
Use of anti-inflammatory medications other than aspirin 60 IU/d or vitamin C >500 mg/d
Pregnancy, breast-feeding or child-bearing potential
History of poor adherence to hemodialysis or medical regimen
Inability to provide consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00732069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.