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mycophenolate mofetil · 1 trial · 2 indications
Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Sirolimus + Daclizumab + Mycophenolate + Corticosteroids |
| 2 | ACTIVE_COMPARATOR | Cyclosporine + Mycophenolate + Corticosteroids |
| Name | Type | Description |
|---|---|---|
| sirolimus | DRUG | 15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12 |
| cyclosporine | DRUG | Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12 |
| mycophenolate mofetil | DRUG | 1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events |
| corticosteroids | DRUG | As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day |
| daclizumab | DRUG | IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation |
Inclusion Criteria: * Kidney transplantation * Donor must be at least 60 years old. Exclusion Criteria: * Current systemic infection * Unstable angina or treatment for serious arrhythmia. * Cancer within the previous 5 years.
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 10 | PHASE3 | INCA034176 |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | Belumosudil, Prednisone, Prednisolone |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Ibrutinib |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Theriva Biologics, Inc. | TOVX | 1 | PHASE1 | Undisclosed |
Mycophenolate mofetil is used for graft versus host disease, a condition where donor immune cells attack the recipient's body after a transplant. It is being studied in the context of kidney transplantation as well. The drug is in Phase 3 clinical development for this indication.
Mycophenolate mofetil is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with graft versus host disease.
Mycophenolate mofetil is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its potential use in graft versus host disease and kidney transplantation.
Mycophenolate mofetil is being evaluated in a Phase 3 clinical trial with the identifier NCT00195273. This completed study, titled 'Study Evaluating Sirolimus in Kidney Transplant Recipients,' enrolled 61 participants in Norway and Sweden. The trial included patients with graft versus host disease and kidney transplantation.
No, mycophenolate mofetil is not the same as sirolimus. The clinical trial NCT00195273 is titled 'Study Evaluating Sirolimus in Kidney Transplant Recipients,' but the drug being developed by Pfizer is mycophenolate mofetil. These are distinct pharmaceutical agents with different mechanisms of action.