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Generated: November 17, 2018

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CLINICAL TRIALS PROFILE FOR MEPRON

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Clinical Trials for Mepron

Trial ID Title Status Sponsor Phase Summary
NCT00405860 CellCept in p-ANCA Vasculitis Completed Roche Pharma AG Phase 1 Microscopic polyangiitis (MP) is a primary systemic vasculitis predominantly affecting small blood vessels. Following the widespread introduction of ANCA testing, the primary systemic vasculitis (SV), Wegener?s granulomatosis (WG) and microscopic polyangiitis (MP) appear to be more frequent than was previously thought (see definitions in Appendix 6). In addition, the existence of early and organ-limited forms of these diseases, such as renal-limited vasculitis (RLV) is now clearly recognized. Their annual incidence exceeds 20 per million per year and they account for at least 5 % of the causes of end stage renal failure. The two diseases share many features of their histology, serology and response to treatment, pointing to similarities in their pathogenesis, which have justified a common approach to their management. The standard treatment with corticosteroids (CS) and cyclophosphamide (CYC) is usually effective at controlling active disease but continued treatment is necessary to prevent disease relapse. Due to the cumulative toxicity associated with CYC treatment, alternatives have been looked for. Mycophenolate mofetil (MMF) has been used to treat patients with a variety of immune-mediated nephritides, including ANCA-associated vasculitis, with less toxicity than CYC but with variable outcome. The present trial will examine whether substitution of oral CYC with oral MMF is equally efficient for induction of remission with less adverse effects in cases of MP with mild to moderate renal involvement. All patients will receive the same regimen of oral prednisone + MMF. Prednisone will be tapered to a stop after 24 weeks but MMF will continue for a total of 18 months unless there is worsening or persistent disease. The trial ends after 18 months.
NCT00405860 CellCept in p-ANCA Vasculitis Completed Mayo Clinic Phase 1 Microscopic polyangiitis (MP) is a primary systemic vasculitis predominantly affecting small blood vessels. Following the widespread introduction of ANCA testing, the primary systemic vasculitis (SV), Wegener?s granulomatosis (WG) and microscopic polyangiitis (MP) appear to be more frequent than was previously thought (see definitions in Appendix 6). In addition, the existence of early and organ-limited forms of these diseases, such as renal-limited vasculitis (RLV) is now clearly recognized. Their annual incidence exceeds 20 per million per year and they account for at least 5 % of the causes of end stage renal failure. The two diseases share many features of their histology, serology and response to treatment, pointing to similarities in their pathogenesis, which have justified a common approach to their management. The standard treatment with corticosteroids (CS) and cyclophosphamide (CYC) is usually effective at controlling active disease but continued treatment is necessary to prevent disease relapse. Due to the cumulative toxicity associated with CYC treatment, alternatives have been looked for. Mycophenolate mofetil (MMF) has been used to treat patients with a variety of immune-mediated nephritides, including ANCA-associated vasculitis, with less toxicity than CYC but with variable outcome. The present trial will examine whether substitution of oral CYC with oral MMF is equally efficient for induction of remission with less adverse effects in cases of MP with mild to moderate renal involvement. All patients will receive the same regimen of oral prednisone + MMF. Prednisone will be tapered to a stop after 24 weeks but MMF will continue for a total of 18 months unless there is worsening or persistent disease. The trial ends after 18 months.
NCT03568994 Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML) Not yet recruiting Texas Children's Hospital Early Phase 1 This study will test daily dosing of atovaquone at established pneumocystis jiroveci pneumonia (PJP) prophylaxis dosing in combination with standard induction chemotherapy for de novo AML. The primary objectives are to determine the frequency of omission of atovaquone doses due to standard induction chemotherapy toxicity, to quantify the steady-state plasma levels of atovaquone, and to determine the time to achievement of steady state atovaquone levels in this population.
NCT03568994 Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML) Not yet recruiting William Marsh Rice University Early Phase 1 This study will test daily dosing of atovaquone at established pneumocystis jiroveci pneumonia (PJP) prophylaxis dosing in combination with standard induction chemotherapy for de novo AML. The primary objectives are to determine the frequency of omission of atovaquone doses due to standard induction chemotherapy toxicity, to quantify the steady-state plasma levels of atovaquone, and to determine the time to achievement of steady state atovaquone levels in this population.
NCT03568994 Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML) Not yet recruiting Baylor College of Medicine Early Phase 1 This study will test daily dosing of atovaquone at established pneumocystis jiroveci pneumonia (PJP) prophylaxis dosing in combination with standard induction chemotherapy for de novo AML. The primary objectives are to determine the frequency of omission of atovaquone doses due to standard induction chemotherapy toxicity, to quantify the steady-state plasma levels of atovaquone, and to determine the time to achievement of steady state atovaquone levels in this population.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Mepron

Condition Name

Condition Name for Mepron
Intervention Trials
MPO-ANCA Vasculitis 1
Microscopic Polyangiitis 1
Acute Myeloid Leukemia 1
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Condition MeSH

Condition MeSH for Mepron
Intervention Trials
Leukemia, Myeloid, Acute 1
Leukemia, Myeloid 1
Leukemia 1
Vasculitis 1
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Clinical Trial Locations for Mepron

Trials by Country

Trials by Country for Mepron
Location Trials
United States 2
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Trials by US State

Trials by US State for Mepron
Location Trials
Texas 1
Minnesota 1
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Clinical Trial Progress for Mepron

Clinical Trial Phase

Clinical Trial Phase for Mepron
Clinical Trial Phase Trials
Phase 1 1
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Mepron
Clinical Trial Phase Trials
Completed 1
Not yet recruiting 1
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Clinical Trial Sponsors for Mepron

Sponsor Name

Sponsor Name for Mepron
Sponsor Trials
Baylor College of Medicine 1
William Marsh Rice University 1
Texas Children's Hospital 1
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Sponsor Type

Sponsor Type for Mepron
Sponsor Trials
Other 4
Industry 1
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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
McKesson
Farmers Insurance
Cerilliant
Argus Health
Moodys
Johnson and Johnson
Fuji
Citi

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