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Secondary Hyperparathyroidism clinical trials

View clinical trials related to Secondary Hyperparathyroidism.

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NCT ID: NCT01421407 Withdrawn - Clinical trials for End Stage Renal Disease

Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Secondary Hyperparathyroidism

Start date: August 2011
Phase: N/A
Study type: Interventional

Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term haemodialysis treatment. sHPT is characterized by persistently elevated levels of parathyroid hormone (PTH) and major disturbances in phosphorus and calcium metabolism. When glomerular filtration rate (GFR) falls, the phosphorus clearance decreases significantly, leading to phosphorus retention. The resulting hyperphosphatemia is thought to be one of the principal causes of secondary hyperparathyroidism which is a very early complication of patients with CKD. Its diagnosis and treatment is crucial in the management of such patients.The treatment of the sHPT of CKD's patient includes dietary phosphate restriction, the use of phosphate binders, correction of hypocalcaemia, the use of vitamin D and its derivatives. The calcimimetic agent cinacalcet hydrochloride may be also used in combination with vitamin D. While the majority of patients can be controlled in this way, medical therapy is not always successful in achieving adequate control of secondary hyperparathyroidism. Oral medications (calcimimetics, recently developed phosphate binders, and active vitamin D derivatives amount to very high monthly costs, and have efficacy limitations as well as side-effects. HIFU may become a valuable alternative treatment that help control secondary hyperparathyroidism in selected patients presenting with enlarged parathyroid gland(s) visible at ultrasonography,. The aim of this study is to evaluate the efficacy and safety of HIFU treatment in chronic haemodialysis patients with secondary hyperparathyroidism presenting with enlarged parathyroid gland(s) which are visible at ultrasonography and for whom medical therapy has been unsuccessful.

NCT ID: NCT01414114 Completed - Clinical trials for Secondary Hyperparathyroidism

Study of KAI-4169 to Treat Secondary Hyperparathyroidism in Hemodialysis Subjects

Start date: December 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of KAI-4169 in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis subjects with chronic kidney disease-mineral and bone disorder (CKD-MBD).

NCT ID: NCT01401478 Completed - Clinical trials for Secondary Hyperparathyroidism

Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation

Start date: July 2011
Phase: N/A
Study type: Observational

Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be assessed during the study.

NCT ID: NCT01382212 Completed - Clinical trials for End-Stage Renal Disease

A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

Start date: October 2011
Phase: Phase 3
Study type: Interventional

The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.

NCT ID: NCT01368042 Completed - Clinical trials for Chronic Kidney Disease

Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous

QUALITIZE
Start date: August 2011
Phase: N/A
Study type: Observational

The purpose of this study is to assess health-related Quality of Life (QoL) changes in participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT) undergoing hemodialysis and receiving paricalcitol intravenous (iv).

NCT ID: NCT01341782 Completed - Hemodialysis Clinical Trials

Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

Start date: May 2011
Phase: Phase 3
Study type: Interventional

This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.

NCT ID: NCT01290029 Completed - Clinical trials for Chronic Kidney Disease

Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease

Start date: January 25, 2011
Phase: Phase 1
Study type: Interventional

The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.

NCT ID: NCT01277510 Terminated - Clinical trials for Chronic Kidney Disease

Pediatric Chronic Kidney Disease Safety and Efficacy

Start date: June 28, 2011
Phase: Phase 3
Study type: Interventional

The 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.

NCT ID: NCT01265992 Completed - Clinical trials for Chronic Kidney Disease

Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis

CAPITOL
Start date: February 2011
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01254565 Completed - Clinical trials for Secondary Hyperparathyroidism

Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Start date: March 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of KAI-4169 in hemodialysis subjects for the treatment of secondary hyperparathyroidism.