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Hyperparathyroidism, Secondary clinical trials

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NCT ID: NCT02056730 Completed - Clinical trials for Hyperparathyroidism, Secondary

The Study of Efficacy and Safety of REGPARA Drug in Dialysis Patients Have High Blood Levels of Parathyroid

Start date: November 2013
Phase: Phase 4
Study type: Interventional

The dialysis patient of chronic kidney disease and parathyroid hormone levels greater than or equal to 800 Pg per ml were divided into two groups by randomized 1:1, one group to receive medication and a control group that did not receive the medication. By group to receive in those taking 25 mg per day to get the default dose and the dose is adjusted according to the levels of calcium and parathyroid hormone. By adjusting the dose of 25 mg every 3 weeks for a period of 12 weeks, the drug is between 25-75 mg dose , with a maximum dose of not more than 100 mg per day (weeks 3, 6 , 9). After a follow-up treatment in weeks 12, 24 and 36 with an blood,ultrasound test parathyroid glands , abdominal x-ray side . To evaluate the changes without the drug .Unless the track during treatment the patients with low blood calcium levels over 8.4 mg per dL . No dose adjustment . regpara while if blood calcium levels less than 7.5 mg per deciliter . Must be stop taking medication for patients in the control group will receive standard treatment . Which consisted of dose vitamin D sterol and parathyroid surgery . Unable to control the level of parathyroid hormone with vitamin D sterol. While participating in the research are not allowed to adjust the amount of vitamin D sterol in the two groups . But the amount of dialysate calcium phosphate binders and can be adjusted as appropriate to healthcare is fine .

NCT ID: NCT02054572 Completed - Clinical trials for Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis

Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis

Start date: February 7, 2014
Phase: Phase 1
Study type: Interventional

The primary objectives of this study were to determine the rate, extent, and routes of radioactivity excretion of [¹⁴C]etelcalcetide in feces, dialysate, and urine over time and to measure radioactivity concentrations in whole blood and plasma over time.

NCT ID: NCT01939977 Completed - Clinical trials for Secondary Hyperparathyroidism Due to Renal Causes

Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.

PARIDOINAL
Start date: January 2014
Phase: Phase 4
Study type: Interventional

To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.

NCT ID: NCT01935856 Completed - Hyperparathyroidism Clinical Trials

Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Start date: August 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis

NCT ID: NCT01932970 Completed - Clinical trials for Hyperparathyroidism, Secondary

Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

Start date: August 12, 2013
Phase: Phase 3
Study type: Interventional

This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).

NCT ID: NCT01922843 Completed - Clinical trials for Kidney Failure, Chronic

A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis

2MD-7H-2B
Start date: September 2013
Phase: Phase 2
Study type: Interventional

The goal of this study is to test a new vitamin D compound for its ability to reduce parathyroid hormone levels in patients who are on hemodialysis.

NCT ID: NCT01896232 Completed - Clinical trials for Chronic Kidney Disease

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Start date: August 13, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

NCT ID: NCT01788046 Completed - Clinical trials for Hyperparathyroidism, Secondary

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Start date: March 12, 2013
Phase: Phase 3
Study type: Interventional

This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.

NCT ID: NCT01785875 Completed - Clinical trials for Hyperparathyroidism, Secondary

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Start date: July 31, 2013
Phase: Phase 3
Study type: Interventional

This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

NCT ID: NCT01785849 Completed - Clinical trials for Hyperparathyroidism, Secondary

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

Start date: March 12, 2013
Phase: Phase 3
Study type: Interventional

This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.