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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05357573 (ClinicalTrials.gov) | August 11, 2022 | 27/4/2022 | Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With TIO | An 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: KRN23 | Kyowa Kirin Co., Ltd. | NULL | Recruiting | 18 Years | N/A | All | 10 | Phase 4 | China |
| 2 | NCT04842032 (ClinicalTrials.gov) | October 5, 2021 | 30/3/2021 | Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH | An 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: KRN23 | Kyowa Kirin Co., Ltd. | NULL | Recruiting | 1 Year | 12 Years | All | 28 | Phase 4 | China |
| 3 | NCT04842019 (ClinicalTrials.gov) | August 30, 2021 | 30/3/2021 | Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLH | An 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/Osteomalacia | X-linked Hypophosphatemia (XLH) | Drug: KRN23 | Kyowa Kirin Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 18 | Phase 4 | China |
| 4 | NCT04159675 (ClinicalTrials.gov) | September 4, 2020 | 7/11/2019 | Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts | Effect 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) | Craniosynostoses | Biological: osteoblast biology study | Hospices Civils de Lyon | NULL | Recruiting | 4 Months | 18 Years | All | 20 | France | |
| 5 | NCT04320316 (ClinicalTrials.gov) | July 31, 2020 | 11/3/2020 | A 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 Rickets | Epidermal Nevus Syndrome | Drug: Crysvita (burosumab-twza) Treatment | University of Alabama at Birmingham | Ultragenyx Pharmaceutical Inc | Completed | 6 Months | N/A | Male | 1 | Phase 4 | United States |
| 6 | NCT03775187 (ClinicalTrials.gov) | April 5, 2019 | 11/12/2018 | Expanded Access to Burosumab | X-linked Hypophosphatemia;Tumor-Induced Osteomalacia | Biological: Burosumab | Ultragenyx Pharmaceutical Inc | Kyowa Kirin Co., Ltd. | Available | N/A | N/A | All | NULL | |||
| 7 | NCT03510455 (ClinicalTrials.gov) | February 27, 2019 | 26/4/2018 | BGJ398 for the Treatment of Tumor-Induced Osteomalacia | BGJ398 for the Treatment of Tumor-Induced Osteomalacia | Tumor-Induced Osteomalacia;Oncogenic Osteomalacia | Drug: BGJ398 | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Completed | 18 Years | 85 Years | All | 4 | Phase 2 | United States |
| 8 | NCT03581591 (ClinicalTrials.gov) | January 31, 2018 | 27/10/2017 | Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets | An 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 Rickets | Hypophosphatemia;Hypophosphatemic Rickets;Pain, Chronic | Biological: Burosumab | Redwood Dermatology Sciences | Ultragenyx Pharmaceutical Inc | Completed | N/A | 18 Years | Female | 1 | Phase 3 | United States |
| 9 | NCT04308096 (ClinicalTrials.gov) | January 9, 2018 | 26/2/2020 | A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia | A 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 Study | XLH | Drug: KRN23 | Kyowa Kirin Co., Ltd. | NULL | Completed | N/A | N/A | All | 27 | Phase 3 | Japan;Korea, Republic of |
| 10 | JPRN-JapicCTI-205284 | 09/1/2018 | 11/05/2020 | A Study of KRN23 in Adult and Pediatric Patients with X-linked Hypophosphatemic Rickets/Osteomalacia | Phase 3 Long-term Extension Study of KRN23 in Patients with X-linked Hypophosphatemic Rickets/Osteomalacia | Adult or pediatric XLH | Intervention 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. | NULL | complete | BOTH | 27 | Phase 3 | Japan, Asia except Japan | ||
| 11 | JPRN-JapicCTI-173614 | 31/7/2017 | 15/06/2017 | A Study of KRN23 in Pediatric Patients with X-linked Hypophosphatemic Rickets/Osteomalacia | A 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/Osteomalacia | Intervention 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. | NULL | complete | 1 | 12 | BOTH | 10 | Phase 3 | Japan |
| 12 | NCT03233126 (ClinicalTrials.gov) | July 6, 2017 | 11/7/2017 | A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia | A 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 Trial | X-linked Hypophosphatemic Rickets/Osteomalacia | Drug: KRN23 | Kyowa Kirin Co., Ltd. | NULL | Completed | 1 Year | 12 Years | All | 16 | Phase 3 | Japan |
| 13 | NCT02722798 (ClinicalTrials.gov) | April 2016 | 7/3/2016 | A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome | A 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 Trial | Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome | Drug: KRN23 | Kyowa Kirin Co., Ltd. | NULL | Completed | 18 Years | N/A | All | 14 | Phase 2 | Japan;Korea, Republic of |
| 14 | NCT03348644 (ClinicalTrials.gov) | August 1, 2015 | 9/10/2017 | Milk Products in the Treatment of Hypophosphatemic Rickets | Milk Products in the Treatment of Hypophosphatemic Rickets: A Randomised Crossover Trial | Hypophosphatemic Rickets | Dietary Supplement: Phosphate tablets.;Dietary Supplement: High cheese intake.;Dietary Supplement: High milk intake. | University of Aarhus | University of East Anglia;Kolding Sygehus;Aarhus University Hospital | Completed | 14 Years | N/A | Female | 7 | N/A | Denmark |
| 15 | JPRN-JapicCTI-163191 | 23/4/2015 | 08/03/2016 | A Phase 2 Open-Label Trial of KRN23 | A 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 Syndrome | Intervention 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. | NULL | complete | 18 | BOTH | 6 | Phase 2 | Japan, Asia except Japan | |
| 16 | NCT02304367 (ClinicalTrials.gov) | March 24, 2015 | 24/11/2014 | Study 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 Osteomalacia | Tumor Induced Osteomalacia (TIO);Epidermal Nevus Syndrome (ENS) | Biological: Burosumab | Ultragenyx Pharmaceutical Inc | NULL | Active, not recruiting | 18 Years | N/A | All | 17 | Phase 2 | United States |
| 17 | NCT02233322 (ClinicalTrials.gov) | August 2014 | 27/8/2014 | Iron Therapy for Autosomal Dominant Hypophosphatemic Rickets: A Pilot Project. | Iron Therapy for Autosomal Dominant Hypophosphatemic Rickets: A Pilot | Autosomal Dominant Hypophosphatemic Rickets | Dietary Supplement: Iron | Indiana University | NULL | Completed | 25 Months | N/A | All | 8 | N/A | United States |
| 18 | NCT02181764 (ClinicalTrials.gov) | July 2014 | 2/7/2014 | A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia | A 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/Osteomalacia | Drug: KRN23 | Kyowa Hakko Kirin Co., Ltd | NULL | Completed | 18 Years | N/A | All | 15 | Phase 1 | Japan;Korea, Republic of |
| 19 | NCT01748812 (ClinicalTrials.gov) | November 16, 2012 | 11/12/2012 | Cinacalcet 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 Hypophosphatemia | Osteomalacia | Drug: Osteomalacia | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Terminated | 18 Years | 70 Years | All | 1 | Phase 1 | United States |
| 20 | JPRN-JapicCTI-101332 | 01/9/2010 | 02/11/2010 | Therapeutic use of Z-521 | Therapeutic use of oral sodium phosphate (Z-521) in primary hypophosphatemic rickets (familial rickets, X-linked hypophosphatemia, vitamin D-resistant rickets) | primary hypophosphatemic rickets | Intervention 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. | NULL | 1 | 14 | BOTH | 10 | Phase 3 | NULL | |
| 21 | NCT01237288 (ClinicalTrials.gov) | September 2010 | 7/11/2010 | Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets | Therapeutic Use of Oral Sodium Phosphate (Z-521) in Primary Hypophosphatemic Rickets | Primary Hypophosphatemic Rickets | Drug: Z-521 | Zeria Pharmaceutical | NULL | Completed | 1 Year | 14 Years | Both | 16 | Phase 3 | Japan |
| 22 | NCT01057186 (ClinicalTrials.gov) | December 2009 | 26/1/2010 | Hypophosphatemic Rickets in Norway | Hypophosphatemic Rickets in Norway | Hypophosphatemia, Familial;Rickets;Hyperphosphatemia | Dietary Supplement: Alfacalcidol; phosphate.;Drug: Sevelamer | Haukeland University Hospital | NULL | Active, not recruiting | N/A | N/A | Both | 80 | N/A | Norway |
| 23 | NCT00844740 (ClinicalTrials.gov) | February 2009 | 12/2/2009 | Calcimimetics in Hypophosphatemic Rickets | Effect of Cinacalcet on the Long-Term Treatment of Familial Hypophosphatemic Rickets | Familial Hypophosphatemic Rickets | Drug: Cinacalcet | Children's Mercy Hospital Kansas City | NULL | Enrolling by invitation | 5 Years | 21 Years | Both | 10 | N/A | United States |
| 24 | NCT00417612 (ClinicalTrials.gov) | January 2007 | 28/12/2006 | Effectiveness of Paricalcitol in Reducing Parathyroid Hormone (PTH) Levels in X-linked Hypophosphatemic Rickets | The Role of Parathyroid Hormone in the Pathogenesis of Skeletal Disease in X-linked Hypophosphatemic Rickets (XLH) | Hypophosphatemia, Familial;Hyperparathyroidism | Drug: Paricalcitol;Other: Placebo | Yale University | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 9 Years | N/A | All | 33 | Phase 3 | United States |
| 25 | ChiCTR-OOC-16010095 | 2006-01-01 | 2016-12-07 | Oral Phosphate Supplements Play an Important Role in Improving the Bone Mineral Density of Hypophosphatemic Osteomalacia Patients | Effect of Phosphate on hypophosphatemia | Hypophosphatemic Osteomalacia | A1: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 University | NULL | Completed | Both | A1:3;A2:5;A3:3;A:21;B:105; | China | |||
| 26 | NCT02720770 (ClinicalTrials.gov) | January 2006 | 15/3/2016 | Growth Hormone Treatment in Children With Hypophosphatemic Rickets | Proposition Pour un Traitement Par Hormone de Croissance Des Enfants Atteints de Rachitisme Hypophosphatemique Familial | X Linked Hypophosphatemic Rickets | Drug: norditropine simplex | Bicetre Hospital | NULL | Completed | 3 Years | 14 Years | Both | 19 | Phase 1/Phase 2 | NULL |
| 27 | NCT00195936 (ClinicalTrials.gov) | June 2005 | 13/9/2005 | Effect of Cinacalcet on Parathyroid Hormone Secretion in Children and Adolescents With Hypophosphatemic Rickets | Effect of Calcimimetic (Cinacalcet) on Phosphate-Induced Hyperparathyroidism in Children With Hypophosphatemic Rickets | Hypophosphatemic Rickets, X-Linked Dominant | Drug: Cinacalcet | Children's Mercy Hospital Kansas City | NULL | Completed | 5 Years | N/A | All | 8 | Phase 1 | United States |
| 28 | NCT00473187 (ClinicalTrials.gov) | August 2004 | 11/5/2007 | Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets | Effects of Growth Hormone Treatment on Body Proportions and Final Height Among Small Children With X-Linked Hypophosphatemic Rickets | Hypophosphatemic Rickets;Growth Disorders;Somatropin Therapy | Drug: somatropin | University of Rostock | NULL | Active, not recruiting | 3 Years | 10 Years | Both | Phase 1 | Germany |