Active clinical trials for "Hyperparathyroidism, Secondary"

The main study aim is to quantify the agreement between the analytical results provided by two third generation and two second generation Parathyroid hormone (PTH) assays. The primary comparison will be performed between the second-generation PTH assay"Intact PTH assay" from Siemens Healthcare Diagnostics Inc. and the third-generation PTH assay "biointact (1-84)" from Roche Diagnostics in terms of a Bland-Altman analysis. Several studies have evaluated the correlation between various PTH assays at a single time-point, but no previous study has tested the hypothesis that longitudinal changes in PTH levels, which are important for making treatment decisions, can be monitored by several PTH assays alike. To this aim, the key secondary objective is to analyze the longitudinal variance in PTH over the course of 1 year, using each of two assays of the second and third generations, respectively. Other secondary objectives include determining changes in serum phosphate, serum calcium, fibroblast growth factor 23 (FGF23), with respect to treatment decisions. For clinical applicability of the results to be obtained here, an important goal of the present study will be not to influence treatment decisions, which will remain independent of the study investigators, at the full responsibility of the hemodialysis physicians. At every quarterly blood draw over the course of one year, the investigators will freeze the serum from 100 patients, and at the end of 4 quarters the investigators will analyze PTH-levels using the following assays: Intact Parathyroid Hormone (Advia Centaur, Siemens Healthcare), PTH-Intact (Cobas, Roche), PTH (1-84) - The agreement between the PTH assays will be analyzed at baseline, as well as at the subsequent quarterly evaluation time-points by Bland-Altman analysis and complemented by Passing-Bablok regression. The longitudinal changes in PTH will be displayed graphically and analyzed by estimating the within-patient variance across time, the between patient variance at each time-point as well as effects on the mean log-PTH level due to course of disease and therapeutic interventions from a linear mixed model.

Secondary hyperparathyroidism (SHPT) is a common serious complication in the maintenance process of hemodialysis patients, characterized by diffuse or nodular hyperplasia of parathyroid glands. Parathyroidectomy for patients with drug-refractory SHPT is recommended in the clinical practice guidelines of the Global Organization for Improving Prognosis in Kidney Disease (KDIGO) and the Japanese Dialysis Therapy Society (JSDT) . Therefore, accurate localization and detection of parathyroid abnormalities is the key to avoid persistent recurrence of the disease. However, the sensitivity and specificity of the existing ultrasound and 99MTC-MIBI diagnosis are limited. CT examination is radiative and requires iodine contrast medium with nephrotoxicity, which may require timely dialysis and long-term monitoring for hemodialysis patients. 3T MRI has no radiation and does not need to use iodine contrast agent, which can well detect parathyroid lesions . Previous studies have reported that 3T MRI can diagnose primary hyperparathyroidism (PHPT), but the diagnostic efficacy of SHPT is still unclear. Therefore, this study aims to evaluate the preoperative diagnostic value of non-enhanced 3T MRI compared with 4DCT in patients with secondary hyperparathyroidism after hemodialysis.

The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of selective Vitamin D Receptor Activator's as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Turkey. The relation of the safety data to PTH (Parathyroid hormone) suppression over time will be evaluated. Also the number and incidence of hypercalcemia and hyperphosphatemia will be recorded.

Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 & 4 Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in Sweden. This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care.

Retrospective chart review to gather information on Sensipar patterns of use and effects on biochemical parameters in renal transplant recipients

Clinical study aimed at improving anemia management in End Stage Renal Disease Patient (ESRD) on maintenance Hemodialysis with evidence of Chronic Kidney disease Mineral Bone Disorder (CKD-MBD)

Objectives include description of current practices; assessment over time of K/DOQI goals, clinical outcomes, health resource utilization(HRU) and patient reported outcomes (PRO) and the impact of Sensipar® on these parameters

Secondary hyperparathyroidism (SHPT) is a multisystemic syndrome that affects calcium and bone homeostasis in patients with chronic kidney disease (CKD). Despite medical treatment, 1-2% of patients require parathyroidectomy anually. The use of an intraoperative paratohormone protocol (IOPTH) to predict cure still in debate, due to the lack of standardized protocols, the use of different assays and uneven PTH clearance. The aim of this study was to determine the diagnostic accuracy of an IOPTH in patients with SHPT for predicting successful surgery after parathyroidectomy.

The MBD-5D is a prospective observational study with a case-cohort and a cohort design. Eligible patients are receiving hemodialysis and have secondary hyperparathyroidism. The study's three goals are (1) to record the patients' characteristics, and variation in the patterns of their treatment; (2) to analyze factors associated with variation in those medical practice patterns; and (3) to identify practice patterns and other factors that affect hospitalization, mortality, and other patient-level outcomes.