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

• Published in: Nephrology, dialysis, transplantation Vol. 27; no. 5; pp. 1942 - 1949
• Main Authors: Ketteler, M., Martin, K. J., Cozzolino, M., Goldsmith, D., Sharma, A., Khan, S., Dumas, E., Amdahl, M., Marx, S., Audhya, P.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.05.2012
• Subjects: Adult; Aged; Aged, 80 and over; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Bone Density Conservation Agents - adverse effects; Bone Density Conservation Agents - therapeutic use; Calcimimetic Agents - adverse effects; Calcimimetic Agents - therapeutic use; Cinacalcet Hydrochloride; Cohort Studies; Disease Management; Dose-Response Relationship, Drug; Drug Therapy, Combination; Emergency and intensive care: renal failure. Dialysis management; Ergocalciferols - adverse effects; Ergocalciferols - therapeutic use; Female; General and cellular metabolism. Vitamins; Humans; Hyperparathyroidism, Secondary - drug therapy; Intensive care medicine; Kidney Diseases - therapy; Male; Medical sciences; Middle Aged; Naphthalenes - adverse effects; Naphthalenes - therapeutic use; Original; Pharmacology. Drug treatments; Practice Guidelines as Topic; Renal Dialysis; Treatment Outcome; Vitamin D - therapeutic use; Endocrinopathy; Human; Kidney disease; Agonist; Urinary system disease; Calcimimetic agent; Hemodialysis; Low dose; Peptide hormone; haemodialysis; Antihormone; Extrarenal dialysis; Treatment; Vitamin D; Parathyroid hormone; Parathyroid diseases; Hydrochlorides; Analog; Renal failure; Paricalcitol; Cinacalcet; cinacalcet hydrochloride; Comparative study; Hyperparathyroidism
• ISSN: 0931-0509; 1460-2385; 1460-2385
• DOI: 10.1093/ndt/gfr531

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. 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. 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%). 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.