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Last Updated: September 21, 2021

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CLINICAL TRIALS PROFILE FOR RAPAMUNE

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505(b)(2) Clinical Trials for Rapamune

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00565773 ↗ Belatacept Post Depletional Repopulation to Facilitate Tolerance Active, not recruiting Bristol-Myers Squibb Phase 2 2007-12-01 Acute rejection is a common problem after a kidney transplant. Rejection can occur when the kidney recipient's immune system tries to attack (or reject) the new kidney. Rejection typically most often develops in the first few months after a transplant. This single center study will seek to determine if a new combination of anti-rejection medications, including the recently FDA approved drug called Belatacept, is better than the current standard anti-rejection drug regimen at preventing rejection. Also to be determined will be whether the new combination of drugs will allow participants to wean off their oral anti-rejection medications over time. This study will test the safety and effectiveness of a new investigational drug combination using alemtuzumab, belatacept, and sirolimus when given with or without donor bone marrow. This combination of medicines has not been tested before in humans. Alemtuzumab (Campath) is approved for use in some types of white blood cell cancers, but is considered investigational in transplant patients. Belatacept is now FDA approved and is being studied in transplant patients. Sirolimus (Rapamune) is approved for use in transplant patients, but its use with belatacept and alemtuzumab is investigational. In the initial 20 subjects enrolled in the study, half tested whether an infusion of bone marrow from the kidney donor would improve the effect of these drugs. This bone marrow infusion was also considered investigational. Enrollment of 20 additional subjects was begun in January, 2013. The donor bone marrow infusion has been eliminated. Enrollment was open to primary living and deceased donor kidney recipients. Enrollment is closed as of 8/12/2014. Funding Source - FDA OOPD
New Combination NCT00565773 ↗ Belatacept Post Depletional Repopulation to Facilitate Tolerance Active, not recruiting Emory University Phase 2 2007-12-01 Acute rejection is a common problem after a kidney transplant. Rejection can occur when the kidney recipient's immune system tries to attack (or reject) the new kidney. Rejection typically most often develops in the first few months after a transplant. This single center study will seek to determine if a new combination of anti-rejection medications, including the recently FDA approved drug called Belatacept, is better than the current standard anti-rejection drug regimen at preventing rejection. Also to be determined will be whether the new combination of drugs will allow participants to wean off their oral anti-rejection medications over time. This study will test the safety and effectiveness of a new investigational drug combination using alemtuzumab, belatacept, and sirolimus when given with or without donor bone marrow. This combination of medicines has not been tested before in humans. Alemtuzumab (Campath) is approved for use in some types of white blood cell cancers, but is considered investigational in transplant patients. Belatacept is now FDA approved and is being studied in transplant patients. Sirolimus (Rapamune) is approved for use in transplant patients, but its use with belatacept and alemtuzumab is investigational. In the initial 20 subjects enrolled in the study, half tested whether an infusion of bone marrow from the kidney donor would improve the effect of these drugs. This bone marrow infusion was also considered investigational. Enrollment of 20 additional subjects was begun in January, 2013. The donor bone marrow infusion has been eliminated. Enrollment was open to primary living and deceased donor kidney recipients. Enrollment is closed as of 8/12/2014. Funding Source - FDA OOPD
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Rapamune

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00037531 ↗ Study Evaluating Sirolimus (Rapamuneā„¢) in Solid Organ Transplant Recipients Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 3 1969-12-31 To evaluate the safety of long-term administration of sirolimus oral solution for up to 5 additional years, or until the tablet formulation is commercially available (whichever occurs first) in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without cyclosporine (CsA). To evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets administered for up to 5 years, or until the tablet formulation is commercially available in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without CsA) or who are currently enrolled in protocol 0468E1-306-US.
NCT00040508 ↗ Sirolimus for Focal Segmental Glomerulosclerosis Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2002-06-01 This study will determine the safety and effectiveness of sirolimus (RapamuneĀ® (Registered Trademark)) in treating focal segmental glomerulosclerosis (FSGS), a disease involving kidney scarring and increased protein in the urine. About one-half of patients with FSGS go on to develop end-stage kidney disease within 6 years, requiring dialysis or kidney transplant. Therapies to reduce urine protein are likely to stop the progression of renal scarring and reduce the chance of developing kidney failure. However, current treatments for FSGS, such as prednisone, cyclophosphamide, and cyclosporine, are not effective in many patients and can cause serious side effects. This study will see if sirolimus, a drug with both anti-scarring and immune suppressing properties, can lower the amount of protein in the urine and slow or stop the kidney disease. Patients 13 years of age and older with FSGS who have had at least one standard treatment for FSGS may be eligible for this 24-month study. Pregnant and nursing women may not participate. Candidates will be screened with a medical history and physical examination, review of medical records and kidney biopsy, 24-hour urine collection, and blood tests. Participants will take sirolimus tablets once a day for 1 year. Three 24-hour urine collections will be done before starting treatment. Blood will be drawn to measure drug levels every week for the first month after starting treatment, then every other week for 1 month, and then every 2 months until treatment stops. Patients who do not have a complete response to the drug at low levels will have their dose increased. Patients will be seen at the NIH clinic in Bethesda, Md., for the screening visit and then at 1, 4, 8, 12, and 15 months for blood and urine tests. Additional urine collections and blood tests will be done periodically throughout the 24-month study period by the patient's local physician. Patients whose urine protein decreases on therapy will be asked to wait 3 months before starting another treatment and will monitored during that time to determine if the response is sustained. Patients whose urine protein levels do not decrease with sirolimus will not be asked to wait 3 months before starting another therapy. Follow-up with the local physician will continue at 18 and 24 months after starting the study. Patients whose urine protein levels increase with sirolimus treatment will be taken off the study and may seek other treatment at any time.
NCT00044720 ↗ Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 4 1969-12-31 The incidence of efficacy failure at 12 months between two regimens.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rapamune

Condition Name

Condition Name for Rapamune
Intervention Trials
Kidney Transplantation 12
Graft vs Host Disease 5
Advanced Cancer 5
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Condition MeSH

Condition MeSH for Rapamune
Intervention Trials
Graft vs Host Disease 11
Syndrome 8
Preleukemia 7
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Clinical Trial Locations for Rapamune

Trials by Country

Trials by Country for Rapamune
Location Trials
United States 167
Canada 11
France 8
Germany 6
India 6
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Trials by US State

Trials by US State for Rapamune
Location Trials
Maryland 15
California 14
Illinois 13
Ohio 11
Florida 11
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Clinical Trial Progress for Rapamune

Clinical Trial Phase

Clinical Trial Phase for Rapamune
Clinical Trial Phase Trials
Phase 4 18
Phase 3 15
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Rapamune
Clinical Trial Phase Trials
Completed 59
Recruiting 24
Not yet recruiting 22
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Clinical Trial Sponsors for Rapamune

Sponsor Name

Sponsor Name for Rapamune
Sponsor Trials
National Cancer Institute (NCI) 15
Wyeth is now a wholly owned subsidiary of Pfizer 15
Pfizer 10
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Sponsor Type

Sponsor Type for Rapamune
Sponsor Trials
Other 125
Industry 50
NIH 30
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