Protocol for treatment of lupus nephritis

Abstract

By employing a pharmacodynamic dosing regimen, the effectiveness of a protocol for treatment of a proteinuric kidney disease with voclosporin can be maximized while minimizing undesirable side effects.

1 - 16 . (canceled) 
     
     
         17 . A pharmacodynamic method to treat a proteinuric kidney disease which method comprises administering to a subject diagnosed with a proteinuric kidney disease predetermined daily dosages of effective amounts of voclosporin over a projected treatment period to an end point, said pharmacodynamic method further comprising:
 (a) measuring urinary protein creatinine ratio (UPCR) of said subject at a first time point prior to said treatment period and a second time point occurring prior to the end point but after the start of the treatment period and determining any reduction of said UPCR between said first and second time points, and   (b) if the UPCR of said subject fails to show a reduction of at least a predetermined amount at said second time point, discontinuing administering voclosporin to the subject and continuing said administering if said predetermined amount of reduction is shown.   
     
     
         18 . The method of  claim 17  which further comprises measuring the concentration of C3/C4 in the blood of said subject at said first and second time points and determining whether the concentration of C3/C4 is normalized at said second time point and if said normalization is found, reinstating or continuing administering voclosporin to the subject and if normalization has not occurred maintaining said discontinuing. 
     
     
         19 . The method of  claim 17  or  18  wherein said method further includes administering to said subject an effective amount of mycophenolate mofetil (MMF). 
     
     
         20 . The method of  claim 17  or  18  which further includes administering to said subject an effective amount of a corticosteroid. 
     
     
         21 . The method of  claim 17  or  18  wherein said predetermined daily dosage is 39.5 mg voclosporin BID or 31.6 mg voclosporin BID or 23.7 mg voclosporin BID or 15.8 mg voclosporin BID or 7.9 mg voclosporin BID. 
     
     
         22 . A method to treat a proteinuric kidney disease which method comprises administering to a subject diagnosed with lupus nephritis a predetermined daily dosage of effective amounts of voclosporin over a projected treatment period of at least 8 weeks, wherein said effective amount is 15.8 mg BID or 7.9 mg voclosporin BID.