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Serving leading biopharmaceutical companies globally:

Covington
Healthtrust
Cantor Fitzgerald
Boehringer Ingelheim
Daiichi Sankyo
Chinese Patent Office
McKesson
Deloitte
Baxter
AstraZeneca

Generated: December 12, 2017

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR
NEORAL

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT00000880 A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV DiseaseCompletedNational Institute of Allergy and Infectious Diseases (NIAID)Phase 2 The purpose of this study is to determine the safety and effectiveness of low doses of cyclosporine (CsA) in patients with early HIV infection and to evaluate its effect on the immune system. Activation of T cells (cells of the immune system) leads to HIV replication. Inhibition of immune activation is therefore a potentially important area of therapy for patients with early HIV infection. CsA is capable of decreasing T cell activation, which in turn may decrease HIV replication.
NCT00000936 A Study To Test An Anti-Rejection Therapy After Kidney TransplantationTerminatedNational Institute of Allergy and Infectious Diseases (NIAID)Phase 3 Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective. Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
NCT00048152 A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant PatientsCompletedHoffmann-La RochePhase 3 This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.
NCT00064701 Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant RecipientsCompletedAstellas Pharma IncPhase 3 The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.
NCT00097968 Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft VasculopathyCompletedNovartis PharmaceuticalsPhase 3 Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation. It is usually used in combination with other immunosuppressive drugs such as cyclosporine. The purpose of this study is to evaluate the change in kidney function after beginning everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with everolimus, in adult cardiac transplant patients who have had their transplanted heart for at least 1 year and who have cardiac allograft vasculopathy.
NCT00098007 A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) PatientsCompletedNovartis PharmaceuticalsPhase 3 The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy. This objective will be assessed by comparing renal function post-transplant between 2 groups of patients.
NCT00101738 Freedom Study: Myfortic in Kidney Transplant PatientsCompletedNovartis PharmaceuticalsPhase 3 The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
NCT00138970 Calcineurin Inhibitor-Free Immunosuppression in Renal Transplant Recipients at Low Immunogenic RiskCompletedUniversity of Oslo School of PharmacyPhase 4 To compare renal function (51Cr-EDTA clearance) 12 months posttransplant, in primary renal allograft recipients (from cadaveric donor) at low immunogenic risk, 0 DR mis-match, receiving immunosuppressive therapy with A) Zenapax® (5 doses), CellCept® (1.5 g bid., aiming for TDM for total trough concentrations of 2-6 mg/L) and prednisolone or B) Sandimmun Neoral® (full dose), CellCept® (1.0 g bid.) and prednisolone.
NCT00148252 Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months PosttransplantTerminatedUniversity of Oslo School of PharmacyPhase 4 To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy
NCT00150046 Efficacy and Safety of Everolimus in de Novo Heart Transplant RecipientsCompletedNovartis PharmaceuticalsPhase 3 This study will test the safety and efficacy of everolimus on heart transplant recipients. This study is not recruiting in the United States.
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Conditions

Condition Name

Condition Name for NEORAL
Intervention Trials
Kidney Transplantation 12
Renal Transplantation 8
Graft Rejection 3
Healthy Volunteers 2
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Condition MeSH

Condition MeSH for NEORAL
Intervention Trials
Preleukemia 4
Myelodysplastic Syndromes 4
Syndrome 3
Graft vs Host Disease 3
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Trial Locations

Trials by Country

Trials by Country for NEORAL
Location Trials
United States 93
Canada 24
Italy 11
Spain 9
France 8
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Trials by US State

Trials by US State for NEORAL
Location Trials
California 10
Florida 7
New York 7
Ohio 6
Wisconsin 5
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for NEORAL
Clinical Trial Phase Trials
Phase 4 19
Phase 3 22
Phase 2 10
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Clinical Trial Status

Clinical Trial Status for NEORAL
Clinical Trial Phase Trials
Completed 40
Terminated 7
Recruiting 6
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for NEORAL
Sponsor Trials
Novartis Pharmaceuticals 13
Novartis 8
National Cancer Institute (NCI) 3
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Sponsor Type

Sponsor Type for NEORAL
Sponsor Trials
Other 52
Industry 38
NIH 5
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Serving leading biopharmaceutical companies globally:

Cerilliant
Moodys
Merck
Chinese Patent Office
Julphar
Dow
Queensland Health
Covington
Daiichi Sankyo
Farmers Insurance

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