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Last Updated: September 18, 2020

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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.
OTC NCT04515329 Tear Film Markers in Dry Eye Syndrome Not yet recruiting Sun Pharma Global FZE Phase 4 2020-09-01 Dry eye is the most common reason for visit to an ophthalmologist's office. The prevalence is on the rise and is mainly attributed to factors such as increased environmental pollution and contact lens use. The current management options are limited to over the counter artificial tear drops and three FDA-approved drugs. Of these, cyclosporine has been used worldwide for treating mild to moderate dry eyes. The earlier version consisted of 0.05% cyclosporine which worked well for a limited number of inflammatory dry eye conditions. Recently, 0.09% cyclosporine was approved by the FDA. The nearly double concentration is expected to be more beneficial for severe inflammation which is often seen in Sjögren syndrome and other Rheumatological conditions associated with dry eyes. In this pilot project, the investigator proposes to evaluate the change in expression of SLURP1 and other markers of ocular surface inflammation before and after treatment with 0.09% cyclosporine eye drops.
OTC NCT04515329 Tear Film Markers in Dry Eye Syndrome Not yet recruiting Vishal Jhanji Phase 4 2020-09-01 Dry eye is the most common reason for visit to an ophthalmologist's office. The prevalence is on the rise and is mainly attributed to factors such as increased environmental pollution and contact lens use. The current management options are limited to over the counter artificial tear drops and three FDA-approved drugs. Of these, cyclosporine has been used worldwide for treating mild to moderate dry eyes. The earlier version consisted of 0.05% cyclosporine which worked well for a limited number of inflammatory dry eye conditions. Recently, 0.09% cyclosporine was approved by the FDA. The nearly double concentration is expected to be more beneficial for severe inflammation which is often seen in Sjögren syndrome and other Rheumatological conditions associated with dry eyes. In this pilot project, the investigator proposes to evaluate the change in expression of SLURP1 and other markers of ocular surface inflammation before and after treatment with 0.09% cyclosporine eye drops.
>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.
>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 169
Myelodysplastic Syndromes 133
Preleukemia 132
Syndrome 130
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Clinical Trial Locations for CYCLOSPORINE

Trials by Country

Trials by Country for CYCLOSPORINE
Location Trials
Canada 144
Italy 95
Germany 84
France 71
Spain 66
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Trials by US State

Trials by US State for CYCLOSPORINE
Location Trials
California 114
Washington 106
Maryland 95
New York 87
Texas 78
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Clinical Trial Progress for CYCLOSPORINE

Clinical Trial Phase

Clinical Trial Phase for CYCLOSPORINE
Clinical Trial Phase Trials
Phase 4 185
Phase 3 157
Phase 2/Phase 3 21
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Clinical Trial Status

Clinical Trial Status for CYCLOSPORINE
Clinical Trial Phase Trials
Completed 459
Recruiting 116
Unknown status 84
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Clinical Trial Sponsors for CYCLOSPORINE

Sponsor Name

Sponsor Name for CYCLOSPORINE
Sponsor Trials
National Cancer Institute (NCI) 169
Fred Hutchinson Cancer Research Center 76
National Heart, Lung, and Blood Institute (NHLBI) 60
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Sponsor Type

Sponsor Type for CYCLOSPORINE
Sponsor Trials
Other 826
Industry 333
NIH 273
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