Paricalcitol versus cinacalcet plus low-dose vitamin D for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: study design and baseline characteristics of the IMPACT SHPT study

Nephrol Dial Transplant. 2012 May;27(5):1942-9. doi: 10.1093/ndt/gfr531. Epub 2011 Sep 19.


Background: Paricalcitol and cinacalcet are common therapies for patients on haemodialysis with secondary hyperparathyroidism (SHPT). We conducted a multi-centre study in 12 countries to compare the safety and efficacy of paricalcitol and cinacalcet for the treatment of SHPT.

Methods: Patients aged ≥18 years with Stage 5 chronic kidney disease receiving maintenance haemodialysis and with intact parathyroid hormone (iPTH) 300-800 pg/mL, calcium 8.4-10.0 mg/dL (2.09-2.49 mmol/L) and phosphorus ≤6.5 mg/dL (2.09 mmol/L) were randomized within two strata defined by the mode of paricalcitol administration to treatment with paricalcitol- (intra-venous, US and Russian sites, IV stratum; oral, non-US and non-Russian sites, oral stratum) or cinacalcet-centred therapy. The primary endpoint is the proportion of patients in each treatment group who achieve a mean iPTH value of 150-300 pg/mL during Weeks 21-28 of treatment. Assuming efficacy response rates of 36 and 66% for cinacalcet and paricalcitol, respectively, and a 20% discontinuation rate, 124 subjects in each stratum were estimated to provide 81% power to detect a 30% absolute difference in the primary endpoint.

Results: Of 746 patients screened, 272 (mean age, 63 years; mean iPTH, 509 pg/mL) were randomized. Mean duration of haemodialysis at baseline was 3.7 years. Comorbidities included hypertension (90.4%), Type 2 diabetes (40.4%), congestive heart failure (17.3%), coronary artery disease (34.6%) and gastrointestinal disorders (75%).

Conclusions: The study participants are representative of a multinational cohort of patients on haemodialysis with elevated iPTH. The study results will provide valuable information on the best available treatment of SHPT in patients on haemodialysis.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Bone Density Conservation Agents / adverse effects
  • Bone Density Conservation Agents / therapeutic use
  • Calcimimetic Agents / adverse effects
  • Calcimimetic Agents / therapeutic use
  • Cinacalcet
  • Cohort Studies
  • Disease Management
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Ergocalciferols / adverse effects
  • Ergocalciferols / therapeutic use*
  • Female
  • Humans
  • Hyperparathyroidism, Secondary / drug therapy*
  • Kidney Diseases / therapy*
  • Male
  • Middle Aged
  • Naphthalenes / adverse effects
  • Naphthalenes / therapeutic use*
  • Practice Guidelines as Topic
  • Renal Dialysis*
  • Treatment Outcome
  • Vitamin D / therapeutic use*


  • Bone Density Conservation Agents
  • Calcimimetic Agents
  • Ergocalciferols
  • Naphthalenes
  • Vitamin D
  • paricalcitol
  • Cinacalcet