Phase 2 N=325 Randomized Quadruple-blind Treatment

Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

End-stage Renal Disease

Bottom Line

View on ClinicalTrials.gov: NCT00237718 ↗

Enrolled (actual)

325

Serious AEs

29.5%

Results posted

Oct 2011

Primary outcome: Primary: F2-isoprostane (F2-iso) — 0.077; 0.073 ng/ml — p=>0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Alpha, gamma, beta, and delta (mixed) tocopherols (Drug); Alpha lipoic acid (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University
Primary completion: Sep 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY F2-isoprostane (F2-iso)	0.077; 0.073	>0.05
SECONDARY Interleukin-6 (IL-6)	19; 20	>0.05

Summary

Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic acid) may decrease these markers.

Eligibility Criteria

Inclusion Criteria

Patients with end-stage renal disease receiving thrice weekly hemodialysis
Age > 18 years
Life expectancy greater than one year
Ability to understand and provide informed consent for participation in the study

Exclusion Criteria

AIDS (HIV seropositivity is not an exclusion criteria)
Active malignancy excluding basal cell carcinoma of the skin
Gastrointestinal dysfunction requiring parenteral nutrition
History of functional kidney transplant 60 IU/day, vitamin C > 500 mg/day over the past 30 days
Patients taking anti-inflammatory medication except aspirin < 325 mg/day over the past 30 days
Patients using a temporary catheter for dialysis access
More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00237718). 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.