Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Steroids · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cyclosporine | DRUG | Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " |
| Steroids | DRUG | Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " |
| Rapamune (Sirolimus) | DRUG | Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " |
Inclusion Criteria: * Age is older than 18 years. * End-stage renal disease, with subjects scheduled for kidney transplant. * Women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following dis...
Steroids is an investigational small molecule being studied for use in kidney failure. It is being evaluated in the context of kidney transplant recipients, where the condition of interest includes kidney failure and graft versus host disease. The drug is currently in Phase 3 clinical development and is not yet approved.
Steroids is being developed by Pfizer, Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol PFE. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with kidney failure.
Steroids is in Phase 3 clinical development. It has completed one Phase 3 trial, which enrolled 150 participants. The drug remains investigational and has not been approved for any use. Further clinical development may be needed to support regulatory submission.
Steroids has been studied in one clinical trial with the identifier NCT00167947. This Phase 3 study, titled 'Study Evaluating Sirolimus in Kidney Transplant Recipients,' was completed and enrolled 150 participants in Italy. The trial included adults aged 18 years and older of all sexes.
Steroids is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for kidney failure. The completed trial NCT00167947 evaluated the drug in kidney transplant recipients, but no approval status has been established. The drug remains under clinical investigation.