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Last Updated: November 13, 2019

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CLINICAL TRIALS PROFILE FOR CYCLOSPORINE

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505(b)(2) Clinical Trials for Cyclosporine

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 NCT00373815 Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease Terminated University Hospital Tuebingen Phase 1 2006-09-01 The present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment CSA/prednisolone with the new combination CSA/prednisolone/everolimus.
New Formulation NCT02961608 Conversion Pharmacodynamic Study in Stable Renal Transplant Patients Receiving Tacrolimus Two Times a Day to a New Formulation of Tacrolimus - LCP Tacro - 1 Time a Day. Recruiting Hospital Universitari de Bellvitge Phase 4 2016-05-01 LCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing. Phase 1 studies demonstrated greater bioavailability than twice-daily tacrolimus capsules and no new safety concerns. - Stable kidney transplant patients can be safely converted from Adoport® twice-daily to LCP-Tacro®. - The greater bioavailability of LCP-Tacro after once-daily dosing results in similar (AUC) exposure, at a dose approximately 30% less, than the total daily dose of Adoport®. - LCP-Tacro provides a slow drug release and this results in flatter kinetics characterized by significantly lower peak-trough fluctuations. - CN is the major cellular target of the calcineurin inhibitors (CNIs) cyclosporine A (CsA) and tacrolimus. The ability of these drugs to inhibit CN activity is dependent on their binding to the respective immunophilins, cyclophilins A and B for CsA and FKBP12 for tacrolimus. - CN inhibition is a rate limiting phenomenon. Over concentrations of tacrolimus does not correlate with an increase in the CN activity.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cyclosporine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000524 Myocarditis Treatment Trial Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1986-07-01 To determine whether immunosuppressive treatment improved cardiac function in patients with biopsy-proven myocarditis.
NCT00000524 Myocarditis Treatment Trial Completed University of Utah Phase 2 1986-07-01 To determine whether immunosuppressive treatment improved cardiac function in patients with biopsy-proven myocarditis.
NCT00000880 A Study to Test the Effect of Cyclosporine on the Immune System of Patients With Early HIV Disease Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 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 Transplantation Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1999-11-01 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.
NCT00001302 A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833 Completed National Cancer Institute (NCI) Phase 1 1992-09-01 The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in-vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable. The purpose of this study is to define the maximum tolerated dose in combination with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine. PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent compound, cyclosporine. This effect will increase the area under the curve (AUC) of vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent cycles both agents will be combined. Escalation of the PSC 833 will continue until a target concentration is reached, or until the maximum tolerated dose is reached. Clinical responses will be monitored in order to provide the best possible medical care to our patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cyclosporine

Condition Name

Condition Name for Cyclosporine
Intervention Trials
Leukemia 106
Myelodysplastic Syndromes 69
Lymphoma 67
Kidney Transplantation 56
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Condition MeSH

Condition MeSH for Cyclosporine
Intervention Trials
Leukemia 166
Preleukemia 131
Myelodysplastic Syndromes 131
Syndrome 129
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Clinical Trial Locations for Cyclosporine

Trials by Country

Trials by Country for Cyclosporine
Location Trials
Canada 142
Italy 95
Germany 84
France 70
Spain 63
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Trials by US State

Trials by US State for Cyclosporine
Location Trials
California 113
Washington 104
Maryland 94
New York 86
Texas 76
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Clinical Trial Progress for Cyclosporine

Clinical Trial Phase

Clinical Trial Phase for Cyclosporine
Clinical Trial Phase Trials
Phase 4 175
Phase 3 156
Phase 2/Phase 3 19
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Clinical Trial Status

Clinical Trial Status for Cyclosporine
Clinical Trial Phase Trials
Completed 456
Recruiting 110
Unknown status 84
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Clinical Trial Sponsors for Cyclosporine

Sponsor Name

Sponsor Name for Cyclosporine
Sponsor Trials
National Cancer Institute (NCI) 165
Fred Hutchinson Cancer Research Center 74
National Heart, Lung, and Blood Institute (NHLBI) 59
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Sponsor Type

Sponsor Type for Cyclosporine
Sponsor Trials
Other 794
Industry 323
NIH 268
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