
Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG...
Secondary HyperparathyroidismThe purpose of this study is to evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).

Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary...
Chronic Kidney DiseaseHyperparathyroidism1 moreThe primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

Active Vitamin D Effect on Left Ventricular Hypertrophy
Chronic Kidney DiseaseSecondary Hyperparathyroidism1 moreLeft ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH. In the present study patients are randomised to 1.25 dihydroxycholecalciferol or no treatment to study the effect on LVH.

Parathyroid Tumor Clonal Status
Parathyroid TumorPrimary HyperparathyroidismTo define the frequency of monoclonal-X and polyclonal-X tumors in PHPT participants having parathyroidectomy (PTX) and to define the relationship between parathyroid tumor clonal status and multiple gland neoplasia (MGN), we will compare surgical and pathologic outcomes to tumor clonal status in a multicenter cohort of patients having bilateral neck exploration (BNE) and PTX (primary objectives).

Pediatric Chronic Kidney Disease Safety and Efficacy
Chronic Kidney DiseaseHyperparathyroidism4 moreThe purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.

Effect of Vitamin D Supplement on Inflammation Markers in High-Risk Cardiovascular Patients With...
Coronary Artery DiseaseChronic Kidney Disease2 moreThe purpose of this study is to determine if vitamin D supplementation changes the results of certain tests associated with inflammation in the body using an oral, synthetic form of vitamin D called paricalcitol.

Cinacalcet to Treat Hypercalcemia in Renal Transplant Recipients
Secondary HyperparathyroidismHypercalcemiaSecondary hyperparathyroidism can persist following successful renal transplantation and can cause high blood calcium, kidney dysfunction or failure and excessive bone loss among other problems. If the condition does not resolve, surgery is frequently required to remove the parathyroid glands, with all the inherent risks of surgery. Cinacalcet, a medicine used to treat secondary hyperparathyroidism in patients with kidney disease, may be effective in treating this condition in the renal transplant recipient. We will study the effect of cinacalcet on calcium, bone and renal function in a 6 month treatment protocol.

Treatment of Secondary Hyperparathyroidism in the Uremic Patient
Secondary HyperparathyroidismChronic Kidney Disease1 moreThe purpose of this study is to compare alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients.

Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy
Sodium Zirconium CyclosilicateHyperkalemia2 moreSodium zirconium cyclosilicate (SZC) has been demonstrated for its serum potassium-lowering efficacy and safety in hyperkalemia hemodialysis patients. However, the effects of SZC during the perioperative period remained unknown. This experiment aimed to determine whether using SZC would impact the serum potassium levels in patients with maintenance hemodialysis after parathyroidectomy (PTX).

Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients
Secondary HyperparathyroidismChronic Kidney Disease Requiring Chronic Dialysis1 moreBackground: 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").