238. ビタミンD抵抗性くる病/骨軟化症 Vitamin D-resistant rickets Clinical trials / Disease details


臨床試験数 : 28 薬物数 : 20 - (DrugBank : 9) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 16

  
No.TrialIDDate_
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PhaseCountries
1NCT05357573
(ClinicalTrials.gov)
August 11, 202227/4/2022Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With TIOAn Open-Label, Multi Center, Single-Cohort, Post-Marketing Phase 4 Study to Evaluate the Efficacy, Pharmacodynamics, and Safety of the Anti-FGF23 Antibody, KRN23, in Adult Chinese Patients With Tumor-Induced Osteomalacia (TIO)Tumor-Induced Osteomalacia (TIO)Drug: KRN23Kyowa Kirin Co., Ltd.NULLRecruiting18 YearsN/AAll10Phase 4China
2NCT04842032
(ClinicalTrials.gov)
October 5, 202130/3/2021Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLHAn Open-label, Multi-center, Single-cohort, Post-marketing Phase 4 Study to Evaluate the Efficacy, Pharmacodynamics, and Safety of the Anti-FGF23 Antibody, KRN23, in Pediatric Chinese Patients With X-linked Hypophosphatemic Rickets/Osteomalacia (XLH)X-linked Hypophosphatemia (XLH)Drug: KRN23Kyowa Kirin Co., Ltd.NULLRecruiting1 Year12 YearsAll28Phase 4China
3NCT04842019
(ClinicalTrials.gov)
August 30, 202130/3/2021Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLHAn Open-label, Multi-center, Single-cohort, Post-marketing Phase 4 Study to Evaluate the Efficacy, Pharmacodynamics, and Safety of the Anti-FGF23 Antibody, KRN23, in Adult Chinese Patients With X-linked Hypophosphatemic Rickets/OsteomalaciaX-linked Hypophosphatemia (XLH)Drug: KRN23Kyowa Kirin Co., Ltd.NULLRecruiting18 Years65 YearsAll18Phase 4China
4NCT04159675
(ClinicalTrials.gov)
September 4, 20207/11/2019Burosumab and 1-25 (OH) Vitamin D on Human OsteoblastsEffect of Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts From Patients Requiring Craniosynostosis Surgery for Idiopathic Reason or Due to Hypophosphatemic Rickets (HR)CraniosynostosesBiological: osteoblast biology studyHospices Civils de LyonNULLRecruiting4 Months18 YearsAll20France
5NCT04320316
(ClinicalTrials.gov)
July 31, 202011/3/2020A Trial to Assess the Safety and Efficacy of KRN23 in Epidermal Nevus Syndrome (ENS)An Open Label Trial to Assess the Safety and Efficacy of KRN23, an Investigational Antibody to FGF23, in a Single Pediatric Patient With Epidermal Nevus Syndrome (ENS) and Associated Hypophosphatemic RicketsEpidermal Nevus SyndromeDrug: Crysvita (burosumab-twza) TreatmentUniversity of Alabama at BirminghamUltragenyx Pharmaceutical IncCompleted6 MonthsN/AMale1Phase 4United States
6NCT03775187
(ClinicalTrials.gov)
April 5, 201911/12/2018Expanded Access to BurosumabX-linked Hypophosphatemia;Tumor-Induced OsteomalaciaBiological: BurosumabUltragenyx Pharmaceutical IncKyowa Kirin Co., Ltd.AvailableN/AN/AAllNULL
7NCT03510455
(ClinicalTrials.gov)
February 27, 201926/4/2018BGJ398 for the Treatment of Tumor-Induced OsteomalaciaBGJ398 for the Treatment of Tumor-Induced OsteomalaciaTumor-Induced Osteomalacia;Oncogenic OsteomalaciaDrug: BGJ398National Institute of Dental and Craniofacial Research (NIDCR)NULLCompleted18 Years85 YearsAll4Phase 2United States
8NCT03581591
(ClinicalTrials.gov)
January 31, 201827/10/2017Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic RicketsAn Open Label Trial to Assess the Safety and Efficacy of Burosumab (KRN23), an Investigational Antibody to FGF23, in a Single Pediatric Patient With Epidermal Nevus Syndrome(ENS) and Associated Hypophosphatemic RicketsHypophosphatemia;Hypophosphatemic Rickets;Pain, ChronicBiological: BurosumabRedwood Dermatology SciencesUltragenyx Pharmaceutical IncCompletedN/A18 YearsFemale1Phase 3United States
9JPRN-JapicCTI-205284
09/1/201811/05/2020A Study of KRN23 in Adult and Pediatric Patients with X-linked Hypophosphatemic Rickets/OsteomalaciaPhase 3 Long-term Extension Study of KRN23 in Patients with X-linked Hypophosphatemic Rickets/Osteomalacia Adult or pediatric XLHIntervention name : burosumab
INN of the intervention : KRN23
Dosage And administration of the intervention : repeated SC administration
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Kyowa Kirin Co., Ltd.NULLcompleteBOTH27Phase 3Japan, Asia except Japan
10NCT04308096
(ClinicalTrials.gov)
January 9, 201826/2/2020A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/OsteomalaciaA Phase 3 Long-term Extension Study of KRN23 in Patients With X-linked Hypophosphatemic Rickets/Osteomalacia and a Post-marketing Study of KRN23 Switched From the Phase 3 Long-term Extension StudyXLHDrug: KRN23Kyowa Kirin Co., Ltd.NULLCompletedN/AN/AAll27Phase 3Japan;Korea, Republic of
11JPRN-JapicCTI-173614
31/7/201715/06/2017A Study of KRN23 in Pediatric Patients with X-linked Hypophosphatemic Rickets/OsteomalaciaA Phase 3 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Pediatric Patients with X-linked Hypophosphatemic Rickets/Osteomalacia X-linked Hypophosphatemic Rickets/OsteomalaciaIntervention name : KRN23
INN of the intervention : burosumab
Dosage And administration of the intervention : repeated SC administration
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Kyowa Kirin Co., Ltd.NULLcomplete112BOTH10Phase 3Japan
12NCT03233126
(ClinicalTrials.gov)
July 6, 201711/7/2017A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/OsteomalaciaA Phase 3 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia and a Postmarketing Study of KRN23 Switched From the Phase 3 TrialX-linked Hypophosphatemic Rickets/OsteomalaciaDrug: KRN23Kyowa Kirin Co., Ltd.NULLCompleted1 Year12 YearsAll16Phase 3Japan
13NCT02722798
(ClinicalTrials.gov)
April 20167/3/2016A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus SyndromeA Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Patients With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome and a Post-marketing Study of KRN23 Switched From the Phase 2 TrialTumor-Induced Osteomalacia or Epidermal Nevus SyndromeDrug: KRN23Kyowa Kirin Co., Ltd.NULLCompleted18 YearsN/AAll14Phase 2Japan;Korea, Republic of
14NCT03348644
(ClinicalTrials.gov)
August 1, 20159/10/2017Milk Products in the Treatment of Hypophosphatemic RicketsMilk Products in the Treatment of Hypophosphatemic Rickets: A Randomised Crossover TrialHypophosphatemic RicketsDietary Supplement: Phosphate tablets.;Dietary Supplement: High cheese intake.;Dietary Supplement: High milk intake.University of AarhusUniversity of East Anglia;Kolding Sygehus;Aarhus University HospitalCompleted14 YearsN/AFemale7N/ADenmark
15JPRN-JapicCTI-163191
23/4/201508/03/2016A Phase 2 Open-Label Trial of KRN23A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Patients with Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome Tumor-Induced Osteomalacia or Epidermal Nevus SyndromeIntervention name : KRN23
INN of the intervention : burosumab
Dosage And administration of the intervention : repeated SC administration, intraindividual dose adjustment
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Kyowa Kirin Co., Ltd.NULLcomplete18BOTH6Phase 2Japan, Asia except Japan
16NCT02304367
(ClinicalTrials.gov)
March 24, 201524/11/2014Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23, an Antibody to FGF23, in Subjects With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)-Associated OsteomalaciaTumor Induced Osteomalacia (TIO);Epidermal Nevus Syndrome (ENS)Biological: BurosumabUltragenyx Pharmaceutical IncNULLActive, not recruiting18 YearsN/AAll17Phase 2United States
17NCT02233322
(ClinicalTrials.gov)
August 201427/8/2014Iron Therapy for Autosomal Dominant Hypophosphatemic Rickets: A Pilot Project.Iron Therapy for Autosomal Dominant Hypophosphatemic Rickets: A PilotAutosomal Dominant Hypophosphatemic RicketsDietary Supplement: IronIndiana UniversityNULLCompleted25 MonthsN/AAll8N/AUnited States
18NCT02181764
(ClinicalTrials.gov)
July 20142/7/2014A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/OsteomalaciaA Phase 1, Multicenter, Open-label, Sequential Dose-escalation, Single-dose Study to Assess the Safety and Tolerability of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia.X-linked Hypophosphatemic Rickets/OsteomalaciaDrug: KRN23Kyowa Hakko Kirin Co., LtdNULLCompleted18 YearsN/AAll15Phase 1Japan;Korea, Republic of
19NCT01748812
(ClinicalTrials.gov)
November 16, 201211/12/2012Cinacalcet for Fibroblast Growth Factor 23 (FGF23)-Mediated Hypophosphatemia (Hypophosphatemic Rickets)Open-label Dose-titration Study of the Tolerability and Efficacy of Cinacalcet to Treat Fibroblast Growth Factor 23 (FGF23)-Mediated HypophosphatemiaOsteomalaciaDrug: OsteomalaciaNational Institute of Dental and Craniofacial Research (NIDCR)NULLTerminated18 Years70 YearsAll1Phase 1United States
20JPRN-JapicCTI-101332
01/9/201002/11/2010Therapeutic use of Z-521Therapeutic use of oral sodium phosphate (Z-521) in primary hypophosphatemic rickets (familial rickets, X-linked hypophosphatemia, vitamin D-resistant rickets) primary hypophosphatemic ricketsIntervention name : Z-521
Dosage And administration of the intervention : 300-3000mg inorganic phosphorus is orally administered in 3 or 4 times per day
Zeria Pharmaceutical Co., Ltd.NULL114BOTH10Phase 3NULL
21NCT01237288
(ClinicalTrials.gov)
September 20107/11/2010Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic RicketsTherapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic RicketsPrimary Hypophosphatemic RicketsDrug: Z-521Zeria PharmaceuticalNULLCompleted1 Year14 YearsBoth16Phase 3Japan
22NCT01057186
(ClinicalTrials.gov)
December 200926/1/2010Hypophosphatemic Rickets in NorwayHypophosphatemic Rickets in NorwayHypophosphatemia, Familial;Rickets;HyperphosphatemiaDietary Supplement: Alfacalcidol; phosphate.;Drug: SevelamerHaukeland University HospitalNULLActive, not recruitingN/AN/ABoth80N/ANorway
23NCT00844740
(ClinicalTrials.gov)
February 200912/2/2009Calcimimetics in Hypophosphatemic RicketsEffect of Cinacalcet on the Long-Term Treatment of Familial Hypophosphatemic RicketsFamilial Hypophosphatemic RicketsDrug: CinacalcetChildren's Mercy Hospital Kansas CityNULLEnrolling by invitation5 Years21 YearsBoth10N/AUnited States
24NCT00417612
(ClinicalTrials.gov)
January 200728/12/2006Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic RicketsThe Role of Parathyroid Hormone in the Pathogenesis of Skeletal Disease in X-linked Hypophosphatemic Rickets (XLH)Hypophosphatemia, Familial;HyperparathyroidismDrug: Paricalcitol;Other: PlaceboYale UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed9 YearsN/AAll33Phase 3United States
25ChiCTR-OOC-16010095
2006-01-012016-12-07Oral Phosphate Supplements Play an Important Role in Improving the Bone Mineral Density of Hypophosphatemic Osteomalacia PatientsEffect of Phosphate on hypophosphatemia Hypophosphatemic OsteomalaciaA1:received phosphate solution doses at a frequency dependent upon measured serum phosphorus levels;A2:received phosphate solution doses only every three to four days;A3:received no phosphate solution;A:Hypophosphatemic Osteomalacia;B:Control;The Second Xiangya Hospital, Central South UniversityNULLCompletedBothA1:3;A2:5;A3:3;A:21;B:105;China
26NCT02720770
(ClinicalTrials.gov)
January 200615/3/2016Growth Hormone Treatment in Children With Hypophosphatemic RicketsProposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique FamilialX Linked Hypophosphatemic RicketsDrug: norditropine simplexBicetre HospitalNULLCompleted3 Years14 YearsBoth19Phase 1/Phase 2NULL
27NCT00195936
(ClinicalTrials.gov)
June 200513/9/2005Effect of Cinacalcet on Parathyroid Hormone Secretion in Children and Adolescents With Hypophosphatemic RicketsEffect of Calcimimetic (Cinacalcet) on Phosphate-Induced Hyperparathyroidism in Children With Hypophosphatemic RicketsHypophosphatemic Rickets, X-Linked DominantDrug: CinacalcetChildren's Mercy Hospital Kansas CityNULLCompleted5 YearsN/AAll8Phase 1United States
28NCT00473187
(ClinicalTrials.gov)
August 200411/5/2007Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic RicketsEffects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic RicketsHypophosphatemic Rickets;Growth Disorders;Somatropin TherapyDrug: somatropinUniversity of RostockNULLActive, not recruiting3 Years10 YearsBothPhase 1Germany