Phase 2
Completed N=325
Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
Source: ClinicalTrials.gov NCT00237718 ↗Enrolled (actual)
325
Serious AEs
29.5%
Results posted
Oct 2011
Primary outcomePrimary: F2-isoprostane (F2-iso) — 0.077; 0.073 ng/ml — p=>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.
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 |
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
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. Informational only — not medical advice.