Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Prograf & Cellcept · 1 trial · 1 indication
The percentage of patients alive at 6 month post transplant.
The percentage of patients alive at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Percent of participants at 6 months with a functioning graft (without graft failure).
The percentage of patients with a functioning graft (without graft failure) at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
Percent of participants at 6 months without acute rejection.
The percentage of patients without acute rejection at 7 years post transplant or at the end of study activities. Not all participants completed 7-year follow-up.
| Arm | Type | Description |
|---|---|---|
| Phase I Arm 1 | ACTIVE_COMPARATOR | CSA and MMF |
| Phase I Arm 2 | ACTIVE_COMPARATOR | FK and MMF |
| Phase II Arm 1 | ACTIVE_COMPARATOR | Low CNI and MMF |
| Phase II Arm 2 | ACTIVE_COMPARATOR | Rapa and MMF |
| Name | Type | Description |
|---|---|---|
| Cyclosporine & Cellcept | DRUG | Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs. |
| Prograf & Cellcept | DRUG | Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs. |
| Low Dose CNI (Cyclosporine or FK) and Cellcept | DRUG | Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs. |
| Rapamune and Cellcept | DRUG | Dose and frequency determined as usual by transplant physicians. The drugs are not experimental drugs. The study is looking at reducing negative side effects of some of the drugs. |
Inclusion Criteria: * Kidney Transplant Recipients \> 18 years old * First or Second Kidney Transplant only Exclusion Criteria: * Kidney Transplant Recipients \< 18 years old * Kidney Transplant Recipients who have a history of \> 2 kidney transplants * Kidney Transplant Recipients with an alread...
Prograf & Cellcept is a combination of two small molecule drugs being studied for use in kidney transplantation. The investigational program focuses on calcineurin inhibitor sparing, which aims to reduce the side effects associated with calcineurin inhibitors. It is currently in Phase 1 clinical development.
Sanofi (ticker: SNY) is the developer of Prograf & Cellcept. The company is conducting clinical research on this combination therapy for kidney transplant patients. The drug is in Phase 1 development, and Sanofi is responsible for its ongoing clinical program.
Prograf & Cellcept is in Phase 1 clinical development. It is an investigational combination therapy and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for its potential use in kidney transplantation.
Prograf & Cellcept has one completed clinical trial, NCT01062555, titled "Calcineurin Inhibitor Sparing After Kidney Transplantation." This Phase 1 study enrolled 527 participants in the United States, with a minimum age of 18 years. The trial was active-controlled and randomized, though not double-blinded.
Prograf & Cellcept is being studied as a calcineurin inhibitor sparing therapy. The clinical trial NCT01062555 evaluates this combination in the context of reducing calcineurin inhibitor exposure after kidney transplantation. The goal is to manage side effects associated with these inhibitors while maintaining effective immunosuppression.