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Hyperparathyroidism, Secondary clinical trials

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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.

NCT ID: NCT01224782 Completed - Clinical trials for Chronic Kidney Disease

Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)

Start date: October 2010
Phase: N/A
Study type: Observational

The aims of this post-marketing observational study (PMOS) are to evaluate the time period needed to achieve > 30% decrease of intact parathyroid hormone (iPTH) compared to the initial values and to provide data on the tolerability and compliance of treatment with Zemplar (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical practice.

NCT ID: NCT01220050 Completed - Clinical trials for Secondary Hyperparathyroidism

Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism

APPLE
Start date: September 2009
Phase: Phase 2
Study type: Interventional

The risk of fracture for kidney transplant recipients is 4 times higher that of the general population. The hyperparathyroidism plays a key role in the maintenance or development of post-transplant alterations of bone remodelling. Renal transplant patients are at high risk of hyperparathyroidism, largely because of long-lasting renal insufficiency before transplant, and of progressive deterioration of kidney function because of chronic allograft nephropathy (a disease of proteinuria and progressive decline of the glomerular filtration rate).In hemodialysis patients, intravenous paricalcitol (19-nor-1,25-dihydroxyvitamin D2), a new vitamin D analogue, achieves a faster and more effective normalization of parathyroid hormone (PTH) levels than calcitriol (1,25-dihydroxyvitamin D3), an effect that is associated with smaller changes in serum calcium and phosphorus levels. Whether oral paricalcitol may help achieving a prompt reduction in serum PTH levels and, secondarily, in urinary protein excretion in renal transplant recipients with secondary hyperparathyroidism is worth investigating.

NCT ID: NCT01219855 Completed - Clinical trials for Chronic Kidney Disease

Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)

Start date: October 2010
Phase: Phase 2/Phase 3
Study type: Interventional

This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).

NCT ID: NCT01191762 Completed - Clinical trials for Chronic Kidney Disease

Sevelamer and Secondary Hyperparathyroidism in Chronic Kidney Disease

Start date: April 2010
Phase: Phase 3
Study type: Interventional

The hypothesis underlying this study is that phosphate interferes with PTH-mediated calcium reabsorption in the distal nephron and thereby necessitates supranormal [PTH]to maintain normocalcemia in chronic kidney disease. This study will examine the hypothesis with measures of phosphate homeostasis and calcium reabsorption. A double-blind trial of the intestinal phosphate binder sevelamer carbonate will be employed to examine whether reductions in phosphate influx alter distal nephron phosphate concentration and the [PTH] required for calcium reabsorption in the expected manner.

NCT ID: NCT01181531 Completed - Clinical trials for Hyperparathyroidism, Secondary

Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

Start date: October 1, 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the doses are adjusted appropriately to maintain serum calcium and phosphorous levels with currently recommended ranges.

NCT ID: NCT01178450 Completed - Clinical trials for Secondary Hyperparathyroidism

Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation

Start date: January 2010
Phase: Phase 4
Study type: Interventional

The hypothesis of this study is that subtotal parathyroidectomy using minimally invasive surgery is superior to cinacalcet for the treatment of persistent secondary hyperparathyroidism (HPT) post renal transplant, with minimal morbidity and significantly reduces the cost of treatment post transplant.