Clinical trials: Sirolimus
Disorder Related to Renal Transplantation
A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation
The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppressive regiments compared to a similar…
- Trial name
- NCT00455013
- Testing
- Thymoglobulin, Belatacept, Sirolimus
- Where
- 17 sites in United States, Italy and 1 more
- Volunteers
- 93 people
- Sponsor
- Bristol-Myers Squibb
Kidney Transplant
Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.
- Trial name
- NCT01025817
- Testing
- Everolimus and tacrolimus, mycophenolate mofetil and tacrolimus
- Where
- 50 sites in United States, Canada
- Volunteers
- 613 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell
Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]
The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent /…
- Conditions
- Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell, Gastrointestinal Stroma Tumors
- Trial name
- STAR-TOR (NCT00700258)
- Testing
- Temsirolimus, Sunitinib, Axitinib
- Where
- 77 sites in Germany
- Volunteers
- 1,520 people
- Sponsor
- Pfizer
Liver Transplantation
REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy
The purpose of this study was, starting from the Italian clinical practice in liver transplantation, to optimize the immunosuppressive therapy, considering specific patient characteristics as alcoholic cirrhosis, hepatitis C…
- Trial name
- REFLECT (NCT02115113)
- Testing
- Everolimus, Tacrolimus
- Where
- 14 sites in Italy
- Volunteers
- 78 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplant
Study Evaluating Rapamune® Maintenance Regimen
Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients. Secondary : 1.
- Trial name
- NCT00478608
- Testing
- Sirolimus (Rapamune®)
- Where
- 9 sites in South Korea
- Volunteers
- 79 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Renal Transplanted Recipients
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and…
- Trial name
- NCT00371826
- Testing
- Everolimus (RAD001), Cyclosporine (Calcineurin Inhibitor (CNI)), Methylprednisone/prednisone
- Where
- 7 sites in Australia
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Coronary Heart Disease
The First-In-Man Pilot Study of Firehawk
This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of Microport for the first time to assess the preliminary safety and feasibility used in the human body.
- Trial name
- NCT02688829
- Testing
- Rapamycin target-eluting Coronary Stent System
- Volunteers
- 21 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Advanced Solid Malignancies
Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of AZD2014
The main purpose of the study is to establish a safe dose of the drug by providing information on any potential side effects this drug may cause and collecting data about how a patient's cancer responds to the drug.
- Trial name
- NCT01026402
- Testing
- AZD2014
- Where
- 2 sites in United Kingdom
- Volunteers
- 172 people
- Sponsor
- AstraZeneca
Renal Transplantation
Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g.
- Trial name
- NCT00154297
- Testing
- Everolimus (RAD001)
- Where
- Switzerland
- Volunteers
- 139 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant.
- Trial name
- NCT00118742
- Testing
- mycophenolate mofetil [CellCept], Tacrolimus, Cyclosporine
- Where
- 46 sites in United States, Canada
- Volunteers
- 293 people
- Sponsor
- Hoffmann-La Roche
Recurrent and Refractory Solid Tumors
Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors
Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with…
- Trial name
- NCT03245151
- Testing
- Lenvatinib, Everolimus
- Where
- 50 sites in United States, Canada
- Volunteers
- 64 people
- Sponsor
- Eisai Inc.
Renal Angiomyolipoma
Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.
The purpose of this study was to assess the safety and efficacy of everolimus (Afinitor®) in Chinese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC).
- Trial name
- NCT03525834
- Testing
- Everolimus
- Where
- 5 sites in China
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Organ Transplantation, Renal Transplantation
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.
- Trial name
- CERTES02 (NCT00154284)
- Testing
- Everolimus (Certican), Cyclosporine (Neoral), Steroid
- Volunteers
- 114 people
- Sponsor
- Novartis
Carcinoma, Large Cell, Neuroendocrine Tumors
RAD001 With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced Large Cell Lung Cancer With Neuroendocrine Differentiation
This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine differentiation treated with a combination of RAD001 with…
- Trial name
- NCT01317615
- Testing
- RAD001, Paclitaxel, Carboplatin
- Where
- 9 sites in Germany
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Hypertension
Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension
mTOR activation has been shown to be relevant in the development and progression of pulmonary hypertension. Inhibition of mTOR has been shown to reverse or regress pulmonary hypertension in animal models.
- Trial name
- NCT02587325
- Testing
- nab-sirolimus
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Aadi Bioscience, Inc.
Lymphoma, Mantle- Cell
Safety and Efficacy of RAD001 in Participants With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy
This study was to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in participants with Mantle Cell Lymphoma who were refractory or intolerant to Velcade® therapy and who had received at least one prior…
- Trial name
- PILLAR-1 (NCT00702052)
- Testing
- Everolimus
- Where
- 31 sites in United States
- Volunteers
- 58 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplant Recipient
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients.
- Trial name
- NCT01150097
- Testing
- Tacrolimus (reduced tacrolimus), Everolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination)
- Where
- 57 sites in United States, Argentina and 14 more
- Volunteers
- 284 people
- Sponsor
- Novartis Pharmaceuticals
Coronary Stenosis
Study Comparing the MiStent SES Versus the XIENCE EES Stent
The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease.
- Trial name
- DESSOLVE III (NCT02385279)
- Testing
- MiStent, XIENCE EES
- Where
- 20 sites in France, Germany and 2 more
- Volunteers
- 1,398 people
- Sponsor
- ECRI bv
Kidney Transplantation
Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids.
- Trial name
- NCT00121810
- Testing
- mycophenolate mofetil [CellCept], Corticosteroids, Calcineurin inhibitors
- Where
- 36 sites in United States
- Volunteers
- 305 people
- Sponsor
- Hoffmann-La Roche
Disorder Related to Cardiac Transplantation
Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation
This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.
- Trial name
- NOCTET (NCT00377962)
- Testing
- Everolimus, Mycophenolic acid (MPA)/azathioprine (AZA), Calcineurin inhibitors (CNI)
- Where
- 6 sites in Denmark, Norway and 1 more
- Volunteers
- 282 people
- Sponsor
- Novartis Pharmaceuticals