Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alpha, gamma, beta, and delta tocopherols · 1 trial · 1 indication
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...
Alpha, gamma, beta, and delta tocopherols are a small molecule combination of vitamin E forms being investigated for use in End-stage Renal Disease. The therapy is being studied in hemodialysis patients to evaluate the provision of antioxidant therapy. It is currently in Phase 2 clinical development.
Alpha, gamma, beta, and delta tocopherols are forms of vitamin E, which act as antioxidants. The therapy is being studied for its potential to provide antioxidant effects in patients with End-stage Renal Disease undergoing hemodialysis. The clinical trial is designed to assess the impact of this antioxidant therapy.
Alpha, gamma, beta, and delta tocopherols are being developed by Fresenius Medical Care AG, a company traded on the New York Stock Exchange under the ticker symbol FMS. The therapy is a small molecule combination of vitamin E forms being studied for End-stage Renal Disease.
Alpha, gamma, beta, and delta tocopherols is in Phase 2 clinical development. It is an investigational therapy for End-stage Renal Disease and has not been approved by regulatory authorities. The therapy is being studied in a completed Phase 2 trial.
Alpha, gamma, beta, and delta tocopherols has been studied in one clinical trial, NCT00237718, titled 'Provision of Antioxidant Therapy in Hemodialysis (PATH) Study'. This Phase 2 trial was completed and enrolled 385 participants with End-stage Renal Disease in the United States.
Alpha, gamma, beta, and delta tocopherols are the four forms of vitamin E. This therapy combines these tocopherols as a small molecule antioxidant treatment being investigated for End-stage Renal Disease. It is being studied in a Phase 2 clinical trial for patients on hemodialysis.