Methods for monitoring and guiding therapeutic suppression of parathyroid hormone in renal patients having secondary hyperparathyroidism

Abstract

The present invention relates to kits for monitoring and guiding therapeutic suppression of parathyroid hormone in renal patients having secondary hyperparathyroidism. The kit provides means to measure the level of a PTH agonist and a PTH antagonist in a patient, and it further provides means for administering a PTH suppressing therapeutic to the patient so as to reduce the level of a PTH agonist and minimize the level of parathyroid hormone antagonist.

1 - 42 . (canceled)  
     
     
         43 . A kit for monitoring and guiding therapeutic suppression of parathyroid hormone in a renal patient having secondary hyperparathyroidism, the kit comprising: 
 a) means for monitoring the level of a parathyroid hormone (PTH) agonist in the patient;    b) means for monitoring the level of a PTH antagonist in the patient; and    c) means for administering to the patient a therapeutic that suppresses PTH agonist, whereby the amount of therapeutic administered is adjusted such that PTH agonist levels are decreased and the level of PTH antagonist is minimized.    
     
     
         44 . The kit of  claim 43 , wherein the therapeutic is selected from the group consisting of vitamin D or vitamin D analogue treatment, calcium treatment, or calcimimetic administration.  
     
     
         45 . The kit of  claim 44 , wherein the Vitamin D analogue comprises paricalcitrol, calcitriol, maxacalcitol, alfacalcidol, calcifediol, or ergocalciferol.  
     
     
         46 . The kit of  claim 43 , further comprising instructions for use.  
     
     
         47 . The kit of  claim 43 , wherein the PTH agonist comprises a contiguous segment of human PTH having the amino acid sequence SEQ ID NO: 1, 
 wherein said segment starts at position 1 of human PTH, and ends at any position from position 34 through position 84 of human PTH.    
     
     
         48 . The kit of  claim 43 , wherein the PTH antagonist comprises a contiguous portion of human PTH having the amino acid sequence SEQ ID NO: 1, 
 wherein said portion starts at any position from position 2 through position 33 of human PTH, ends at any position from position 35 through position 84 of human PTH, and has a minimal length of three amino acid residues.    
     
     
         49 . The kit of  claim 43 , wherein the PTH agonist is a peptide having an amino acid sequence of human PTH 1-84  set forth in SEQ ID NO: 1.  
     
     
         50 . The kit of  claim 43 , wherein the PTH antagonist is a peptide having an amino acid sequence of human PTH7-84 (SEQ ID NO: 7).  
     
     
         51 . The kit of  claim 43 , wherein the means for measuring the PTH antagonist level in a patient comprises means for measuring a total PTH level in a patient, whereby the PTH antagonist level in the patient is determined by subtracting the PTH agonist level in the patient from the total PTH level in the patient.  
     
     
         52 . The kit of  claim 43 , wherein the means for determining a PTH antagonist level comprises an antibody that distinguishes PTH antagonist from PTH agonist.  
     
     
         53 . The kit of  claim 43 , wherein the means for determining a PTH agonist level comprises an antibody that distinguishes PTH agonist from PTH antagonist.  
     
     
         54 . A kit for monitoring and guiding therapeutic suppression of parathyroid hormone in a renal patient having secondary hyperparathyroidism, the kit comprising: 
 means for monitoring the level of a PTH antagonist in the patient; and    means for administering to the patient a therapeutic that suppresses PTH agonist, whereby the amount of therapeutic administered is adjusted such that the level of PTH antagonist in the patient is minimized.    
     
     
         55 . The kit of  claim 54 , wherein the PTH antagonist is a peptide having an amino acid sequence of human PTH7-84 (SEQ ID NO: 7).  
     
     
         56 . The kit of  claim 54 , wherein the means for determining a PTH antagonist level comprises an antibody that distinguishes PTH agonist from PTH antagonist.  
     
     
         57 . The kit of  claim 54 , wherein the PTH agonist is a peptide having an amino acid sequence of human PTH 1-84  set forth in SEQ ID NO: 1.  
     
     
         58 . The kit of  claim 54 , wherein the therapeutic is selected from the group consisting of vitamin D or vitamin D analogue treatment, calcium treatment, or calcimimetic administration.  
     
     
         59 . The kit of  claim 58 , wherein the vitamin D analogue comprises paricalcitrol, calcitriol, maxacalcitol, alfacalcidol, calcifediol, or ergocalciferol.