Clinical trials: Phosphorus
X-linked Hypophosphatemia
Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)
The objectives of the study are to: Identify a dose and dosing regimen of burosumab, based on safety and pharmacodynamic (PD) effect, in pediatric XLH participants Establish the safety profile of burosumab for the treatment of…
- Trial name
- NCT02163577
- Testing
- burosumab
- Where
- 9 sites in United States, France and 2 more
- Volunteers
- 52 people
- Sponsor
- Kyowa Kirin, Inc.
Chronic Kidney Disease, Dialysis
A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Trial name
- NCT00542815
- Testing
- MCI-196, Another Phosphate binder (Sevelamer)
- Where
- 115 sites in Austria, Czechia and 13 more
- Volunteers
- 632 people
- Sponsor
- Tanabe Pharma Corporation
X-Linked Hypophosphatemia
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
The primary objectives of the study are to: Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers…
- Trial name
- NCT02750618
- Testing
- Burosumab
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Kyowa Kirin, Inc.
X-Linked Hypophosphatemia
Registry for Patients With X-Linked Hypophosphatemia
This is an international, multicentre, prospective, non-interventional, observational Registry of patients with X-Linked hypophosphatemia (XLH).
- Trial name
- NCT03193476
- Where
- 118 sites in Belgium, Bulgaria and 18 more
- Volunteers
- 1,489 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
X-linked Hypophosphatemia (XLH)
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in pediatric Chinese patients with XLH
- Trial name
- NCT04842032
- Testing
- KRN23
- Where
- 5 sites in China
- Volunteers
- 28 people
- Sponsor
- Kyowa Kirin Co., Ltd.
X-linked Hypophosphatemia, Hypophosphatemic Rickets
X-linked Hypophosphatemia Disease Monitoring Program
The objectives of this observational study are to characterize XLH disease presentation and progression and to assess long-term effectiveness and safety of burosumab.
- Trial name
- NCT03651505
- Testing
- No intervention
- Where
- 38 sites in United States, Argentina and 4 more
- Volunteers
- 782 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Dental Caries
Comparative Study of Experimental Dental Adhesive With and Without Phosphoric Acid Pretreatment
The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric…
- Trial name
- NCT02071953
- Testing
- Experimental adhesive w/out phosphoric acid in post. rest., Experimental adhesive with phosphoric acid in post. rest.
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Dentsply International
X-Linked Hypophosphatemia
Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH
The primary objective of this study is to evaluate the effect of KRN23 (burosumab) therapy in improving rickets in children with XLH compared with active control (oral phosphate/active vitamin D).
- Trial name
- NCT02915705
- Testing
- burosumab, Oral Phosphate Supplement, active vitamin D
- Where
- 16 sites in United States, Australia and 5 more
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin, Inc.
Renal Fanconi Syndrome, Photophobia
Biomarker for Cystinosis Disease: BioCystinosis (BioCystinosis)
Development of a new mass spectrometry-based biomarker for the early and sensitive diagnosis of Cystinosis disease from the blood
- Conditions
- Renal Fanconi Syndrome, Photophobia, Hypophosphatemia
- Trial name
- BioCystinosis (NCT02837523)
- Where
- 4 sites in Germany, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock
Nursing Education, Hemodialysis
Phosphorus Education and Adherence in Hemodialysis Patients
By applying statistical methods such as analysis of variance (ANOVA), this study incorporates both the content and the intensity (frequency) of educational interventions to design multiple regression models for evaluating…
- Trial name
- NCT07080840
- Testing
- Nursing education A+1, Nursing education A+2, Nursing education A+3
- Where
- Taiwan
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Jen-Ai Hospital Institutional Review Board
Hyperphosphatemia, Kidney Disease
Fosrenol Post-marketing Surveillance in Japan
This study is a regulatory post-marketing surveillance in Japan and it is a local prospective and observational study of patients who have received Fosrenol.
- Trial name
- NCT01955876
- Testing
- Lanthanum Carbonate (Fosrenol, BAY77-1931)
- Where
- Japan
- Volunteers
- 343 people
- Sponsor
- Bayer
X-Linked Hypophosphataemia
A UK Multicentre, Health-Related Quality of Life Study for Children and Adolescents With XLH
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…
- Trial name
- NCT04819490
- Where
- 6 sites in United Kingdom
- Volunteers
- 32 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
X-linked Hypophosphatemia (XLH)
Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age
A Phase 1/2, Open-label, Multicenter, Non-randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Paediatric Patients from Birth to Less than 1 Year of Age with X-linked Hypophosphatemia…
- Trial name
- NCT04188964
- Testing
- Burosumab
- Where
- 9 sites in Austria, France and 4 more
- Volunteers
- 16 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Hyperphosphatemia
Long-term Effect of Lanthanum Carbonate on Bone
Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia, including lanthanum carbonate (Fosrenol), for an…
- Trial name
- NCT00557323
- Testing
- Lanthanum carbonate
- Where
- 19 sites in United States, Germany and 1 more
- Volunteers
- 34 people
- Sponsor
- Shire
X-linked Hypophosphatemic Rickets/Osteomalacia
A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 administered subcutaneously once every 2 weeks in children with X-linked hypophosphatemic rickets/osteomalacia(XLH).
- Trial name
- NCT03233126
- Testing
- KRN23
- Where
- 4 sites in Japan
- Volunteers
- 16 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Chronic Kidney Disease, Dialysis
Long-term Extension Study of MCI-196
The Primary Objectives of this study are to assess the long-term efficacy of treatment with colestilan (MCI-196) (including combination therapy) and to assess the long-term safety of treatment with colestilan (MCI-196) (including…
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Paediatric
- Trial name
- NCT01814917
- Testing
- colestilan, CBPB
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Tanabe Pharma Corporation
X-Linked Hypophosphatemia
A Study to Describe the Lived Experience of XLH for Adolescents at End of Skeletal Growth
An observational, prospective, mixed-methods study involving the integration of quantitative and qualitative data exploring the lived experience of burosumab-treated adolescents with XLH at the end of skeletal growth.
- Trial name
- NCT05181839
- Testing
- Burosumab
- Where
- 14 sites in France, Germany and 3 more
- Volunteers
- 25 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Chronic Kidney Disease, Dialysis
Dose-finding Study of MCI-196
The Primary Objective of this study is to determine the initial starting doses of colestilan (MCI-196) in paediatric subjects with Chronic Kidney Disease Stage 5 on Dialysis and with Hyperphosphataemia.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Paediatric
- Trial name
- NCT01814904
- Testing
- colestilan-L, colestilan-M, colestilan-H
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Tanabe Pharma Corporation
Hyperphosphatemia
Fosrenol Post-marketing Surveillance for Hemodialysis in Japan
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in hemodialysis who received Fosrenol for hyperphosphatemia.
- Trial name
- FOSRENOL-HD (NCT01419327)
- Testing
- Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
- Where
- Japan
- Volunteers
- 3,267 people
- Sponsor
- Bayer
Hyperphosphatemia
Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for…
- Trial name
- FOSRENOL-CAPD (NCT01412398)
- Testing
- Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet
- Where
- Japan
- Volunteers
- 446 people
- Sponsor
- Bayer