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Rapamune

Phase 3

Kidney Disease | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Mar 10, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment470

FDA Designations

No designations recorded

Clinical trial landscape

Rapamune · 3 trials · 3 indications

Phase 3 2Phase 2 1
NCT00470665Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant RecipientsRenal Allograft Recipients
COMPLETED460 Analytics
NCT00248313Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking SirolimusKidney Disease
COMPLETED470 Analytics
PHASE3COMPLETED
Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients
Renal Allograft RecipientsUnlock trial analytics
PHASE3COMPLETED
Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus
Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation.
Kidney Function at 12 months after transplantation.
Graft function as measured by calculated creatinine clearance at month 6 post-transplantation.

Secondary Endpoints

Kidney function at 6 months; incidence of side effects and rejection at 6 and 12 months.
Blood serum creatinine, incidence of biopsy-confirmed acute graft rejection, and patient and graft survival at 6 months; presumptive acute rejection; incidence of infection; histologically-confirmed lymphoproliferative disease or malignancy.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Interventions

NameTypeDescription
RapamuneDRUG -
Rapamune®DRUG -
Rapamune® (Sirolimus)DRUG -
TacrolimusDRUG -
CorticosteroidsDRUGPerioperative
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Eligibility Criteria

Age Range13 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion criteria: * Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor. * Age \>= 13 years...

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Frequently asked questions about Rapamune

What is Rapamune used for?

Rapamune is used for kidney transplantation, specifically in renal allograft recipients and patients with kidney disease. It is an immunosuppressant small molecule developed by Pfizer, Inc. (NYSE: PFE) to help prevent organ rejection in kidney transplant patients.

How does Rapamune work?

Rapamune works by inhibiting the mammalian target of rapamycin (mTOR), a key protein kinase that regulates cell growth and proliferation. By blocking mTOR, Rapamune suppresses the immune system's T-cell response, which helps prevent the rejection of transplanted kidneys in renal allograft recipients.

Who makes Rapamune?

Rapamune is developed by Pfizer, Inc., a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is responsible for the research, development, and commercialization of this immunosuppressant medication for kidney transplant patients.

What phase is Rapamune in?

Rapamune is in Phase 3 clinical development for kidney transplantation and related kidney disease indications. It has completed multiple clinical trials, including Phase 3 studies, and remains an investigational drug in active clinical development for these uses.

What clinical trials is Rapamune in?

Rapamune has been studied in several completed clinical trials, including NCT00248313, a Phase 3 study comparing cyclosporin dose reduction with elimination in kidney transplant recipients taking sirolimus, and NCT00470665, a Phase 3 study comparing sirolimus-based regimens in high-risk renal transplant recipients. These trials enrolled hundreds of patients.

Is Rapamune the same as sirolimus?

Yes, Rapamune is the brand name for sirolimus, an immunosuppressant drug. In clinical trials, it is often referred to as sirolimus, and Rapamune is the proprietary name used by Pfizer. Both names refer to the same active pharmaceutical ingredient used in kidney transplantation.