Nephrol Dial Transplant (2012) 27: 1942–1949 doi: 10.1093/ndt/gfr531 Advance Access publication 19 September 2011 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 Markus Ketteler1, Kevin J. Martin2, Mario Cozzolino3, David Goldsmith4, Amit Sharma5, Samina Khan6, Emily Dumas6, Michael Amdahl6, Steven Marx6 and Paul Audhya6 1Division of Nephrology, Klinikum Coburg, Coburg, Germany, 2Department of Internal Medicine, Division of Nephrology, Saint Louis University, St Louis, MO, USA, 3Department of Medicine, Surgery and Dentistry, University of Milan, Renal Division, Hospital San Paolo, Milan, Italy, 4Renal and Transplantation Department, Guy’s Hospital, London, UK, 5Boise Kidney and Hypertension Institute, Boise, ID, USA and 6Abbott Laboratories, Abbott Park, IL, USA Correspondence and offprint requests to: Markus Ketteler; E-mail:
[email protected] Abstract Introduction Background. Paricalcitol and cinacalcet are common thera- pies for patients on haemodialysis with secondary Secondary hyperparathyroidism (SHPT) is a major compli- hyperparathyroidism (SHPT). We conducted a multi-centre cation of chronic kidney disease (CKD) [1] resulting from study in 12 countries to compare the safety and efficacy of impaired calcium and phosphate homeostasis and a lack of paricalcitol and cinacalcet for the treatment of SHPT. vitamin D receptor (VDR) activation secondary to active Methods. Patients aged 18 years with Stage 5 chronic kidney disease receiving maintenance haemodialysis and vitamin D deficiency [2, 3]. SHPT is characterized by with intact parathyroid hormone (iPTH) 300–800 pg/mL, increased parathyroid hormone (PTH) synthesis and secre- calcium 8.4–10.0 mg/dL (2.09–2.49 mmol/L) and phospho- tion and progressive parathyroid gland hyperplasia [2].