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Hyperparathyroidism, Secondary clinical trials

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NCT ID: NCT06236295 Recruiting - Clinical trials for Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis

Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial

Start date: February 20, 2024
Phase: Phase 2
Study type: Interventional

This is a multicenter, single-arm, long-term safety and tolerability trial. A total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled.

NCT ID: NCT06130683 Recruiting - Clinical trials for Secondary Hyperparathyroidism

Single-Cell Sequence Technology Used to Reveal Heterogeneity of Secondary Hyperparathyroidism

Start date: November 8, 2023
Phase:
Study type: Observational

This project intends to select cases that meet the research requirements, take secondary hyperparathyroidism, primary hyperparathyroidism and normal human parathyroid tissue, a total of three groups, 4 cases in each group, through the method of single-cell transcription and sequencing, construct a map of human parathyroid function types, reveal the gene structure and gene expression status of cells, and visualize the expression characteristics, intercellular heterogeneity, and heterogeneity of cell subsets of secondary hyperparathyroid cells in a hierarchical manner, draw a single-cell map, and compare the differences between groups. To explore the pathogenesis of secondary hyperparathyroidism. Secondary hyperparathyroidism, parathyroid tissue of primary hyperparathyroidism and normal parathyroid tissue obtained by accident were collected, frozen and preserved, frozen tissue thawed, single-cell suspension was prepared and each cell was specifically labeled by the Mozhuo Genomics system, after oil breaking, polymerase chain reaction amplification, reverse transcription to obtain complementary DNA, and a library of complementary DNA that passed quality inspection was constructed to obtain high-quality data of parathyroid cells. Cell Ranger, R Seurat package, and t-SNE dimensionality reduction diagram were used to reduce the dimensionality, cluster, and visualize the data. In order to construct a single-cell atlas of parathyroid glands, investigators performed cluster analysis of similar cells according to the gene expression profile, and then visualized the data by t-SNE. According to the results of cell clustering, the specific and highly expressed genes in each cell cluster were identified. Cell populations were identified according to the expression of landmark genes, and the differences in cell types and proportions between groups were compared.

NCT ID: NCT06126016 Recruiting - Clinical trials for Secondary Hyperparathyroidism

A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.

Start date: October 19, 2023
Phase:
Study type: Observational

The purpose of this study is to evaluate the efficacy and safety of pacitol Inj.(paricalcitol) for secondary hyperparathyroidism with stage 5D chronic kidney disease (CKD 5D) receiving hemodialysis

NCT ID: NCT05880914 Recruiting - Clinical trials for Chronic Kidney Diseases

Precision Medicine Approaches to Renal Osteodystrophy

PMaROD
Start date: December 21, 2022
Phase: Early Phase 1
Study type: Interventional

Treatment of renal osteodystrophy is impeded by the lack of practical and accurate tools to determine underlying bone turnover. Gold standard bone biopsy is not practical in the clinic for the vast majority of kidney disease patients and parathyroid hormone and bone alkaline phosphatase have insufficient accuracy for turnover type to safely and confidently guide treatment of renal osteodystrophy. In the present investigation, the investigators will study a microRNA approach as a novel non-invasive biomarker of turnover for renal osteodystrophy.

NCT ID: NCT05836220 Recruiting - Clinical trials for Secondary Hyperparathyroidism

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2

PATH-2
Start date: May 15, 2023
Phase: Phase 3
Study type: Interventional

This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases. First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks. After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.

NCT ID: NCT05832931 Recruiting - Clinical trials for Secondary Hyperparathyroidism

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1

PATH-1
Start date: April 28, 2023
Phase: Phase 3
Study type: Interventional

This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases. First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks. After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.

NCT ID: NCT05549154 Recruiting - Clinical trials for Vitamin D Deficiency

A Study on Prevention Strategies for CKD-SHPT and Related Complications Based on General Vitamin D Supplementation

Start date: December 5, 2022
Phase: N/A
Study type: Interventional

1. Study content: This is a multicentre, double-blind, randomised controlled study to determine the optimal dose and duration of treatment for the correction of vitamin D insufficiency or deficiency in patients with CKD5d; to investigate whether vitamin D supplementation delays the increase in PTH levels in this group of patients; and to investigate the effects on changes in CKD-MBD-related markers, cardiovascular complications, cognitive function in this group of patients. 2. Study procedure: Based on the inclusion and exclusion of the patients, the study was conducted in accordance with the following criteria 2. Study procedure: Eligible subjects were screened according to inclusion and exclusion criteria and randomly divided into three groups: high-dose vitamin D group, low-dose vitamin D group and control group. Baseline data were collected before the intervention and each group was given different doses of regular vitamin D2 softgels or placebo and followed up. 25(OH)D, PTH, blood Ca, and blood P levels were measured every month; bone metabolism markers, FGF23, and blood counts, liver function, kidney function, lipids, and blood glucose were measured every 3 months; the prevalence of vascular calcification, the incidence of cardiovascular events, and changes in cognitive function scale scores were assessed 6 months after the intervention.

NCT ID: NCT05543928 Recruiting - Clinical trials for Vitamin d Deficiency

Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism

Start date: January 31, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.

NCT ID: NCT04922892 Recruiting - Clinical trials for Secondary Hyperparathyroidism;Parathyroidectomy

Total Parathyroidectomy With Autotransplantation Versus Total Parathyroidectomy Alone for Secondary Hyperparathyroidism

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Total parathyroidectomy with autotransplantation (TPTX+AT) and Total parathyr- oidectomy alone (TPTX) are the common surgical procedures.The purpose of the study was to compare the long-term benefits of surgery between the two groups.

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).