Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2012
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.
Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Cinacalcet plus vitamin D versus vitamin D alone for the treatment of secondary hyperparathyroidism in patients undergoing dialysis: a meta-analysis of randomized controlled trials.International urology and nephrology · 2019Pooled it
- Calcimimetics for secondary hyperparathyroidism in chronic kidney disease patients.The Cochrane database of systematic reviews · 2014Pooled it
- Pooled it
- Cost effectiveness of paricalcitol versus cinacalcet with low-dose vitamin D for management of secondary hyperparathyroidism in haemodialysis patients in the USA.Clinical drug investigation · 2014Trial
- Paricalcitol versus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: results of the IMPACT SHPT study.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2012Trial
- Clinical value of serum iPTH, ALP and serum markers levels in patients with secondary hyperparathyroidism receiving paricalcitol combined with cinacalcet.Journal of medical biochemistry · 2025Article
- Effect of calcium supplementation on severe hypocalcemia in patients with secondary hyperparathyroidism after total parathyroidectomy.World journal of clinical cases · 2022Article
- Article
- Risk factors predicting severe hypocalcemia after total parathyroidectomy without autotransplantation in patients with secondary hyperparathyroidism.The Journal of international medical research · 2020Article
- Factors associated with parathyroid hormone control in haemodialysis patients with secondary hyperparathyroidism treated with cinacalcet in real-world clinical practice: Mimosa study.Clinical kidney journal · 2019Article
- Efficacy and safety of cinacalcet and active vitamin D in the treatment of secondary hyperparathyroidism in patients with chronic kidney disease: a network meta-analysis.Annals of translational medicine · 2019Article
- Three Therapeutic Strategies: Cinacalcet, Paricalcitol or Both in Secondary Hyperparathyroidism Treatment in Hemodialysed Patients During 1-Year Observational Study-A Comparison.Frontiers in endocrinology · 2019Article
- Article
- Which vitamin D in CKD-MBD? The time of burning questions.BioMed research international · 2013Review
- Lipids, blood pressure, kidney - what was new in 2011?Archives of medical science : AMS · 2011Article
- The Clinical Efficacy Evaluation of the KHA-200 Hemoperfusion Device in the Treatment of End-Stage Renal Disease Patients Undergoing Blood Purification Therapy.Kidney diseases (Basel, Switzerland)Article
Corrections and comments
- Commented on byWhat is it for?2012
Authors and funding
10 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundParicalcitol 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.
methodsPatients 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.
resultsOf 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%).
conclusionsThe 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.
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