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Hyperparathyroidism, Secondary clinical trials

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NCT ID: NCT04523974 Not yet recruiting - Clinical trials for Hyperparathyroidism; Secondary, Renal

Preemptive and Precise Intervention for CKD-SHPT

Start date: October 1, 2020
Phase:
Study type: Observational

Through multi-center randomized controlled trial studies on preemptive surgical intervention in patients with chronic kidney disease (CKD) - secondary hyperparathyroidism (SHPT), to precisely evaluate the safety and effectiveness during perioperative period, and the long-term outcomes by 1-year follow-up. The follow-ups include the evaluation of the overall quality of life, calcium and phosphorus metabolism, hyperparathyroidism level, vitamin D metabolism, bone mineral density, soft tissue and vascular calcification.

NCT ID: NCT04484116 Completed - Clinical trials for Secondary Hyperparathyroidism

IOPTH Usefulness for Predicting Successful Surgery in Secondary Hyperparathyroidism

Start date: July 1, 2017
Phase:
Study type: Observational

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.

NCT ID: NCT04267965 Completed - Clinical trials for Secondary Hyperparathyroidism Due to Renal Causes

Pulmonary Function, Voice and Swallowing Symptoms After Parathyroidectomy

Start date: August 1, 2017
Phase:
Study type: Observational [Patient Registry]

In this study, investigators measure patient's voice frequency, swallowing function, and O2 desaturation of the 6 mins walking test before surgery and 4 months after surgery, to find the increase of voice frequency, and swallowing function and the decrease of O2 desaturation.

NCT ID: NCT04126954 Not yet recruiting - Clinical trials for Hyperparathyroidism, Secondary

Study on the Use of Cinacalcet in Phosphocalcic Context.

CALCI-CINA
Start date: January 2020
Phase:
Study type: Observational

Currently, the indications used for MA (Marketing Authorization) Cinacalcet in France are hyperparathyroidism (hyperPTH) in adults, whether primary (for patients in whom parathyroidectomy is theoretically indicated but in whom it is contraindicated or not is not clinically appropriate) or secondary to a chronic kidney disease, and parathyroid carcinomas. In pediatric patients, data on its use are restricted due to its recent marketing authorization (2017) and limited to dialysis patients suffering from secondary hyperPTH. Nevertheless, some patients with phosphocalcic pathologies without renal insufficiency must be treated off-label by cinacalcet in the presence of severe hyperPTH, without any other chronic treatment available to date. The objective of this study is therefore to evaluate the use in France of cinacalcet in phosphocalcic pathologies without renal insufficiency, in order to obtain efficacy and safety data in order to improve our knowledge on the management of these orphan diseases.

NCT ID: NCT04064827 Recruiting - Clinical trials for Chronic Kidney Disease (CKD)

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

Start date: September 16, 2020
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).

NCT ID: NCT03969329 Recruiting - Clinical trials for Secondary Hyperparathyroidism

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

Start date: December 20, 2019
Phase: Phase 3
Study type: Interventional

Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects between ≥ 2 to < 18 years of age, with chronic kidney disease (CKD) on hemodialysis

NCT ID: NCT03960437 Completed - Clinical trials for Vascular Calcification

The Effect of Etelcalcetide on CKD-MBD

Parsabiv-MBD
Start date: September 6, 2018
Phase: Phase 2
Study type: Interventional

The proposed study will investigate the effects of etelcalcetide on the bone and blood-vessel health in patients with CKD-MBD. The investigators will test if etelcalcetide makes bone and blood-vessels healthier. The study hypotheses are that are that etelcalcetide keeps bones strong and lowers the risk of calcium deposits in blood vessels. In Aim 1, the investigators will test if 9-months of treatment with etelcalcetide improves bone strength in twenty ESKD patients with hyperparathyroidism (HPT) by bone biopsy. In Aim 2, the investigators will test if 9-months of treatment with etelcalcetide decreases serum propensity to calcify blood vessels. The potential significance of this study is to provide first-time data on the ability of etelcalcetide to protect bone and blood-vessel health in patients with ESKD.

NCT ID: NCT03937349 Completed - Clinical trials for Secondary Hyperparathyroidism

Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

Start date: May 14, 2019
Phase:
Study type: Observational

This is a prospective cohort study aimed to evaluate change of cardiovascular calcification after parathyroidectomy in patients with end-stage renal disease on dialysis compared with control group on conservative treatment.

NCT ID: NCT03822507 Completed - Clinical trials for Secondary Hyperparathyroidism

Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

Start date: April 9, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.

NCT ID: NCT03801980 Completed - Clinical trials for Secondary Hyperparathyroidism

Phase 3 Study of SK-1403

Start date: January 21, 2019
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.