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Label indication Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: • Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation ( 1.1 ).
Also known as Rapamune® (Sirolimus), sirolimus, Rapamycin
Rapamune · 11 trials · 9 indications
The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).
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.
Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.
Change over six months in cognitive functioning in Sturge-Weber syndrome is the primary outcome measure. This outcome will be assessed using the NIH Toolbox Cognitive Battery, a panel of testing which includes the following measures: * the Flanker Inhibitory Control and Attention Test (executive function and attention) * the Dimensional Change Card Sort Test (executive function) * Picture Sequence Memory Test (episodic memory) * Oral Reasoning Recognition Test and Picture Vocabulary Test (language skills) * Pattern Comparison Processing Speed Test (processing speed) * List Sorting Working Memory Test (working memory) * 9-hole Peg Test (dexterity) * Grip Strength Test (grip strength) and * Patient-Reported Outcomes Measurement Information System (PROMIS) (self-report emotional functioning). These scores are rescaled to T scores (mean = 50, standard deviation (SD) = 10), referenced against the US population. Higher scores indicate better outcome. T scores only were analyzed.
DF, also known as peak to trough fluctuation (PTF) (calculated as \[Cmax minus Ctrough\] divided by Cave), is a unit-less ratio of the Cmax to Ctrough decrease expressed as a fraction of the average concentration during a dosing interval.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | Sirolimus + Daclizumab + Mycophenolate + Corticosteroids |
| 2 | ACTIVE_COMPARATOR | Cyclosporine + Mycophenolate + Corticosteroids |
| Sirolimus | EXPERIMENTAL | All subjects will receive the sirolimus oral solution to be taken at home twice daily and will be treated on an outpatient basis. The drug will be taken for six months. |
| Name | Type | Description |
|---|---|---|
| Sirolimus (Rapamune®) | DRUG | (1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level. |
| 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 " |
| 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 |
| 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 |
| Rapamune | DRUG | - |
| tacrolimus | DRUG | - |
| Cyclosporine A | DRUG | - |
| Rapamune® | DRUG | - |
| Sirolimus (RAPAMUNE) | DRUG | - |
| Rapamune® (Sirolimus) | DRUG | - |
Inclusion Criteria: 1. Age greater than or equal to 13 years of age. 2. End-stage renal disease in patients scheduled to receive a primary renal allograft from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch donor is defined as ...
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Rapamune is used in nephrology for kidney transplantation and renal allograft recipients, and it has also been studied in kidney disease and kidney failure. It is a small molecule immunosuppressant developed by Pfizer, Inc. (PFE) and has been evaluated in Phase 3 clinical trials.
Rapamune is developed and marketed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company responsible for the drug's clinical development and regulatory submissions.
Rapamune has been studied in Phase 3 clinical trials. The development program includes completed Phase 3 studies in renal allograft recipients and kidney disease, as well as a completed Phase 2 trial in kidney transplantation.
Rapamune has been evaluated in several completed trials, including NCT00470665 comparing sirolimus/Prograf versus sirolimus/CsA in high-risk renal transplant recipients, NCT00248313 comparing cyclosporin dose reduction with elimination in kidney transplant recipients taking sirolimus, and NCT00167947 evaluating sirolimus in kidney transplant recipients.
Yes, Rapamune is the brand name for sirolimus. The drug is also referred to as Rapamune® (Sirolimus) and Rapamune®. These names all refer to the same small molecule immunosuppressant developed by Pfizer.