View clinical trials related to Hyperparathyroidism, Secondary.
Filter by:This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.
Background: Calcimimetic therapy has been shown to reduce systemic FGF23 levels, which themselves are associated with left ventricular hypertrophy (LVH) in chronic kidney disease (CKD). Methods/design: This is a randomized multicenter trial in which the effect of etelcalcetide in comparison to alfacalcidol on LVH and cardiac fibrosis in hemodialysis patients with secondary hyperparathyroidism (sHPT) will be investigated. The investigators will perform a comparative trial testing etelcalcetide vs. alfacalcidol treatment on top of conventional HPT therapy for 12 months. A total of 62 hemodialysis patients with sHPT and LVH will be enrolled in the study. After a washout of all calcimimetic and vitamin D treatment, subjects will be randomized at 1:1 ratio to either etelcalcetide or alfacalcidol. The participants will undergo cardiac imaging consisting of cardiac resonance imaging (cMRI) and strain echocardiography before and at baseline and one year. Etelcalcetide or alfacalcidol will be administered intravenously three times per week following chronic hemodialysis treatment. The primary end point will be a change in left ventricular mass index (LVMI) measured in g/m2. As secondary end points the changes in left atrial diameter (LAD), cardiac fibrosis, wall motion abnormalities and left ventricular function, changes in serum FGF 23 and soluble Klotho levels as well as changes in proBNP as well as pre- and postdialysis troponin T (TnT) levels will be determined. Additionally a quantitative analysis of the treatment influence on the individual metabolites of the renin-angiotensin-aldosterone system (RAAS) will be performed using mass spectrometry ("RAAS fingerprint").
The aim of this study is to evaluate the prevalence of secondary hyperparathyroidism among patients with diabetic nephropathy.
1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT; 2. To explore the impact of Cinacalcet HCL using on the combined use of drugs; 3. To explore the difference of patients who continued or discontinued Cinacalcet HCL in real-world period from 33rd to 52nd week.
Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective was to observe the adverse effects between these two treatment regimens.
The pharmacoepidemiological EPHEYL (Étude PHarmacoÉpidémiologique de l'hYperparathyroïdie secondaire en Lorraine) study is a 2-year, open-cohort, prospective, observational study on incident SHPT, i.e. newly diagnosed, with a 2 year follow-up, set in the 12 dialysis units located in the French region of Lorraine (public or private).
This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
This study investigates whether calcium citrate or calcium carbonate are the optimal supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass operation. Half of the participants will be randomized to receive calcium citrate, while the other half will receive calcium carbonate. The study will be double blinded.
This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week extension period to evaluate long-term safety and efficacy.
This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.