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 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 | ||
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 | |
| 12 | 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 |
| 13 | 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 |