Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00237718 | Provision of Antioxidant Therapy in Hemodialysis (PATH) Study | PHASE2 | COMPLETED | 385 | — | — | Apr 1, 2006 | Sep 1, 2010 | Jan 11, 2012 | 1 | United States |
F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.
| Arm | Type | Description |
|---|---|---|
| ALA and Vitamin E | ACTIVE_COMPARATOR | 600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of alpha, gamma, beta and delta (mixed) tocopherols (Vitamin E) taken orally on a daily basis for 6 months |
| Placebo | PLACEBO_COMPARATOR | placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months |
| Name | Type | Description |
|---|---|---|
| Alpha, gamma, beta, and delta (mixed) tocopherols | DRUG | approximately 666 IU daily (1 pill) for 6 months |
| Alpha lipoic acid | DRUG | 600 mg daily (2 pills 300 mg each) for 6 months |
| Placebo | DRUG | placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months |
Inclusion Criteria: 1. Patients with end-stage renal disease receiving thrice weekly hemodialysis 2. Age \> 18 years 3. Life expectancy greater than one year 4. Ability to understand and provide informed consent for participation in the study Exclusion Criteria: 1. AIDS (HIV seropositivity is not...