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Hypophosphatemia clinical trials

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NCT ID: NCT05098249 Completed - Anemia Clinical Trials

Ferric Carboxymaltose With or Without Phosphate Substitution for the Treatment of Iron Deficiency or Iron Deficiency Anemia

Start date: November 11, 2021
Phase: Phase 4
Study type: Interventional

This is a confirmatory trial to establish superior serum phosphate stability associated with use of Phoscap® compared with placebo as a supplement for treatment of iron deficiency or iron deficiency anemia with Ferinject® before elective surgery.

NCT ID: NCT04946409 Active, not recruiting - Clinical trials for X Linked Hypophosphatemia

Burden of Disease and Functional Impairment in XLH

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

Observational study comprising prospective follow up as well as retrospective chart review in order to evaluate the longitudinal course of the disease in XLH patients with a specific focus on functional impairment, physical performance and complications associated with the disease or respective treatment.

NCT ID: NCT04872907 Not yet recruiting - Clinical trials for X-linked Hypophosphatemia (XLH)

Prevention of Spontaneous Dental Abscesses in Children With X-linked Hypophosphatemia : a RCT

PRADEX
Start date: June 1, 2021
Phase: Phase 3
Study type: Interventional

This study is a prospective, randomized, single-blind, split-mouth, national multicenter trial, comparing the efficacy of a self-etch adhesive system combined (SAM) with a flowable composite to that of a fluoride varnish for the prevention of spontaneous dental abscesses in children with XLH. For each patient, according to randomization, one side of the oral cavity is treated with the experimental treatment (application of the adhesive system to healthy anterior and posterior temporary teeth, and application of the flowable composite to healthy posterior temporary teeth), and the other side with the active comparator (fluoride varnish). The application process for both treatments is similar and will be renewed every 6 months (visits at 6, 12, 18 and 24 months) systematically for the SAM and the varnish, and in case of partial or total loss of the composite.

NCT ID: NCT04846647 Completed - Clinical trials for Unexplained Hypophosphatemia

Study of the Inappropriate Secretion of FGF23 in Patients Followed in Hospital in a Context of Hypophosphatemia

IFEH
Start date: October 5, 2021
Phase:
Study type: Observational

The discovery of FGF23, the missing link in the long researched and finally found phosphate metabolism, marked a turning point in the understanding and physiopathology of specific hypophosphatemia. By inhibiting the renal reabsorption of phosphate and the production of calcitriol, FGF23 behaves like a hypophosphatemia hormone. Hypersecretion of FGF23 can occur in the case of genetic abnormalities (X-linked hypophosphatemic vitamin-resistant rickets, recessive or dominant hypophosphatemic rickets, McCune-Albright syndrome ...) or acquired abnormalities (oncogenic osteomalacia). Oncogenic osteomalacia can be induced by hyperproduction of FGF23 by benign tumours of mesenchymal origin. But more recently, several cases of malignant tumours secreting FGF23 have also been described (prostate, colon, breast, ovarian and lung cancers, pulmonary carcinoma, etc.)

NCT ID: NCT04842032 Active, not recruiting - Clinical trials for X-linked Hypophosphatemia (XLH)

Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH

Start date: November 1, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in pediatric Chinese patients with XLH

NCT ID: NCT04842019 Active, not recruiting - Clinical trials for X-linked Hypophosphatemia (XLH)

Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLH

Start date: September 28, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in adult Chinese patients with XLH

NCT ID: NCT04819490 Completed - Clinical trials for X-Linked Hypophosphataemia

A UK Multicentre, Health-Related Quality of Life Study for Children and Adolescents With XLH

Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

This study aims to provide Health-related Quality of Life (HRQoL) data from children and adolescents with growing skeletons in the United Kingdom (UK), including those treated with burosumab or alternative XLH treatment, as part of an updated submission to the SMC in early 2023. This study will utilise data from a subset of UK sites already within the XLH Registry (including participating Scottish sites) and collect additional HRQoL data within these sites (that are otherwise not included in the wider XLH Registry protocol). The HRQoL data will enable the calculation of HRQoL to derive the HRQoL utility estimates in children and adolescents with growing skeletons for the RSS health states, hence addressing an area of uncertainty.

NCT ID: NCT04814641 Recruiting - Bronchiolitis Clinical Trials

Hypophosphatemia and Bronchiolitis

Start date: March 21, 2021
Phase:
Study type: Observational

Bronchiolitis is a major public health problem and the leading cause of paediatric intensive care unit admission in infants. Hypophosphatemia is common in adult intensive care units and was associated with an increase of the duration of mechanical ventilation and the length of stay. Our hypothesis is that hypophosphatemia is common in bronchiolitis and could be a marker of severity.

NCT ID: NCT04695860 Completed - Clinical trials for X-linked Hypophosphatemia

Anti-FGF23 (Burosumab) in Adult Patients With XLH

BurGER
Start date: January 7, 2021
Phase: Phase 3
Study type: Interventional

X-linked hypophosphatemia (XLH) rare genetic disorder due by inactivating mutations in the PHEX gene leading to increased levels in FGF-23. Elevated FGF-23 reduces renal phosphate reabsorbtion and and limits 1-alpha hydroxylase driven Vitamin D activation, eventually leading to phosphate wasting, defective bone mineralization and additional health issues. Burosumab is a recombinant fully human IgG1 monoclonal antibody developed to treat XLH by binding FGF23, thereby restoring normal phosphate homeostasis. BUR03 is a Phase 3b open-label, single-arm, single-center study to confirm the efficacy and safety of Burosumab treatment in adult (age ≥18 years) XLH patients without upper age limit and irrespective of baseline pain level and to further evaluate the efficacy in this cohort and the assocaited effect of treatment on physical functioning, mobility and activity. The study aims at enrolling and treating 34 subjects with a confirmed diagnosis of XLH with q4w s.c. injection of Burosumab 1mg/kg body weight over 48 weeks. Primary objective is to attiain normal serum phosphorus levels, secondary objectives include key parameters of physical function and activity, mobility and mineral homeostasis.

NCT ID: NCT04519762 Not yet recruiting - Hypophosphatemia Clinical Trials

Levels of 'Hypophosphatemia Affect Outcome of Septic Patients in ICU

Start date: September 15, 2020
Phase: Phase 4
Study type: Interventional

The current study aimed to determine the incidence of hypophosphatemia (HP) among severe sepsis/septic shock patients admitted to ICU and its impact on morbidity and mortality rates of these patients, and to evaluate the impact of phosphorous supplemental therapy (PST) on such outcomes.Thus, this study will hypothesize that diagnosis and management of HP may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to ICU.