title: 2MD (DP001), a Single Agent in the Management of Hemodialysis Patients: A Randomized Trial.
abstract: Vitamin D analogs and calcimimetics are used to manage secondary hyperparathyroidism (SHPT) in dialysis patients. DP001 is an oral vitamin D analog that suppresses parathyroid hormone (PTH) in uremic rats, osteopenic women, and hemodialysis patients. The safety and effectiveness of DP001 suppressing PTH in dialysis patients previously managed with active vitamin D with or without a calcimimetic are presented.
  
  
  
  A multicenter, randomized, double-blind study compared DP001 to placebo in hemodialysis patients with serum-intact PTH (iPTH) ≥300 pg/ml. The primary efficacy endpoint was the proportion of patients achieving 2 consecutive ≥30% decreases in iPTH levels during the 12 weeks of treatment. Calcium, phosphorus, calcium × phosphorus product and safety were also evaluated. The responses to DP001 were compared in patients previously treated with both active vitamin D and a calcimimetic to those previously on active vitamin D alone.
  
  
  
  Sixty-two patients were randomized (n = 34 DP001; n = 28 placebo). At week 12, 78% of all DP001-treated patients and 7% of all placebo-treated patients achieved the primary endpoint (p < 0.0001); iPTH fell 45% in the DP001 group and increased 37% in the placebo group. No patient exceeded the safety threshold of 2 consecutively corrected serum calcium levels ≥11.0 mg/dl. Patients previously on cinacalcet plus active vitamin D also responded to DP001 (n = 10) resulting in a 55% decrease in iPTH, while those on placebo (n = 9) increased by 70%.
  
  
  
  DP001 safely and effectively suppressed iPTH in hemodialysis patients with SHPT that were previously managed with active vitamin D alone or with a calcimimetic (www.clinicaltrials.gov, NCT01922843).
authors.affiliation: Division of Nephrology, Massachusetts General Hospital, Harvard Medical School, Boston, Mass., USA.
authors.forename: Ravi
authors.initials: R
authors.lastname: Thadhani
authors.forename: Julia B
authors.initials: JB
authors.lastname: Zella
authors.forename: Danielle C
authors.initials: DC
authors.lastname: Knutson
authors.forename: William J
authors.initials: WJ
authors.lastname: Blaser
authors.forename: Lori A
authors.initials: LA
authors.lastname: Plum
authors.forename: Margaret
authors.initials: M
authors.lastname: Clagett-Dame
authors.forename: Raymond D
authors.initials: RD
authors.lastname: Buck
authors.forename: Hector F
authors.initials: HF
authors.lastname: DeLuca
mesh_terms: D000328:Adult; D000368:Aged; D002117:Calcitriol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002118:Calcium / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000378:metabolism; D010758:Phosphorus / Q000378:metabolism; D006435:Renal Dialysis; D016896:Treatment Outcome
chemical_list: C519954:2-methylene-19-nor-(20S)-1alpha,25-dihydroxyvitamin D3; D010281:Parathyroid Hormone; D010758:Phosphorus; D002117:Calcitriol; D002118:Calcium