225. 先天性腎性尿崩症 Congenital nephrogenic diabetes insipidus Clinical trials / Disease details
臨床試験数 : 15 / 薬物数 : 48 - (DrugBank : 18) / 標的遺伝子数 : 31 - 標的パスウェイ数 : 65
| 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 | NCT05044611 (ClinicalTrials.gov) | January 11, 2023 | 27/8/2021 | AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients With Bipolar Disorder Treated With Lithium | AMIloride for the Treatment of Nephrogenic Diabetes Insipidus for Patients With Bipolar Disorder Treated With Lithium: a Randomized Controlled Trial | Bipolar Disorder | Drug: Anhydrous Amiloride Hydrochloride;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | 70 Years | All | 148 | Phase 4 | France |
| 2 | NCT05190744 (ClinicalTrials.gov) | September 1, 2022 | 29/12/2021 | PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration | A Multi-center, Open-Label, Exploratory Study to Assess the Efficacy of PB in Decreasing the Urine Output and Increasing the Urine Osmolality in Patients With Hereditary Nephrogenic Diabetes Insipidus, Patients With Autosomal Dominant Polycystic Kidney Disease Treated With Tolvaptan, And Severely Polyuric Patients With Previous Lithium Administration (Serendipity-PB1) | Autosomal Dominant Polycystic Kidney Disease;Nephrogenic Diabetes Insipidus;Acquired Nephrogenic Diabetes Insipidus;Congenital Nephrogenic Diabetes Insipidus | Drug: PB | Mayo Clinic | Hopital du Sacre-Coeur de Montreal | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 3 | NCT04939753 (ClinicalTrials.gov) | May 26, 2021 | 27/4/2021 | Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the ICU: a Retrospective Analysis | Incidence of Nephrogenic Diabetes Insipidus During Prolonged Sevoflurane Sedation in the Intensive Care Unit: a Retrospective Analysis | Nephrogenic Diabetes Insipidus | Drug: Sevoflurane | Universitair Ziekenhuis Brussel | NULL | Recruiting | 18 Years | N/A | All | 1000 | Belgium | |
| 4 | EUCTR2020-002204-38-DK (EUCTR) | 24/11/2020 | 07/05/2020 | Treatment of the genetic disease nephrogenic diabetes insipidus with the antifungal drug Fluconazole | Treatment of congenital nephrogenic diabetes insipidus with fluconazole, an antifungal medication | Nephrogenic diabetes insipidus MedDRA version: 21.0;Level: LLT;Classification code 10012600;Term: Diabetes insipidus nephrogenic;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | INN or Proposed INN: Fluconazole Other descriptive name: FLUCONAZOLE | Claus Bistrup | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 10 | Phase 2 | Denmark | ||
| 5 | JPRN-jRCTs031180369 | 12/04/2018 | 18/03/2019 | Tolvaptan for nephrogenic diabetes insipidus | Exploratory study of tolvaptan use for nephrogenic diabetes insipidus caused by mutation in vasopressin type 2 receptor - Tolvaptan use for NDI by V2R mutation | Nephrogenic diabetes insipidus Nephrogenic diabetes insipidus, polyuria;D018500 | Starting tolvaptan from 60 mg and dose up to 90mg and 120mg in every 1 or 2 days. | Makita Noriko | NULL | Recruiting | >= 20age old | Not applicable | Both | 3 | Phase 1-2 | Japan |
| 6 | EUCTR2016-001591-30-DK (EUCTR) | 06/11/2017 | 09/03/2017 | Treatment of congenital nephrogenic diabetes insipidus with riociguat or sildenafil | Treatment of congenital nephrogenic diabetes insipidus with a guanylate cyclase stimulator, riociguat or a phosphodiesterase type 5 inhibitor, sildenafil | Nephrogenic diabetes insipidus because of AVP2R-mutation MedDRA version: 20.0;Level: LLT;Classification code 10012626;Term: Diabetes nephrogenic (excludes glycosuria);System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Adempas Product Name: Adempas INN or Proposed INN: RIOCIGUAT Other descriptive name: RIOCIGUAT Trade Name: Viagra Product Name: Viagra INN or Proposed INN: SILDENAFIL | Odense University Hospital | NULL | Not Recruiting | Female: no Male: yes | 2 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Denmark | ||
| 7 | NCT02967653 (ClinicalTrials.gov) | July 13, 2017 | 15/11/2016 | Atorvastatin for the Treatment of Lithium-Induced Nephrogenic Diabetes Insipidus | Atorvastatin for the Treatment of Lithium-Induced Nephrogenic Diabetes Insipidus: A Randomized Controlled Trial | Lithium Use, Nephrogenic Diabetes Insipidus | Drug: Atorvastatin | Lady Davis Institute | NULL | Completed | 18 Years | 85 Years | All | 60 | Phase 2 | Canada |
| 8 | JPRN-UMIN000021708 | 2016/04/18 | 18/04/2016 | A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene. | A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene. - A study to evaluate effect and safety of Tolvaptan in Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene. | Nephrogenic Diabetes Insipidus caused by mutations in the vasopressin type 2 receptor gene | 1) Administration of Tolvaptan once per day (60mg/day, 90mg/day, 120mg/day), each dose for two days. 2) Administration of Tolvaptan 120mg per day for 2 to 4 weeks in outpatient. | Department of Nephrology and Endocrinology, The University of Tokyo Hospital | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 3 | Not selected | Japan |
| 9 | NCT02460354 (ClinicalTrials.gov) | September 2015 | 29/5/2015 | Metformin and Congenital Nephrogenic Diabetes Insipidus | Use of Metformin to Treat Patients With Congenital Nephrogenic Diabetes Insipidus (NDI) | Diabetes Insipidus | Drug: Metformin | Emory University | NULL | Terminated | 18 Years | N/A | Male | 2 | Phase 1 | United States |
| 10 | EUCTR2012-001809-24-NL (EUCTR) | 31/07/2013 | 06/09/2012 | A diminished concentrating ability of the kidneys due to lithium prescription: how many and whom is affected? | Evaluation of urinary concentrating defects in lithium treated patients with a dDAVP test - Nephrogenic diabetes insipidus (NDI) in lithium treated patients | lithium-induced urinary concentrating defects (nephrogenic diabetes insipidus) MedDRA version: 15.0;Level: LLT;Classification code 10050501;Term: Lithium toxicity;System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 15.0;Classification code 10012600;Term: Diabetes insipidus nephrogenic;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Desmopressine nasal spray 10 mg/ml, flacon 60 doses Product Name: Desmopressine nasal spray 10 mg/ml, flacon 60 doses Product Code: SUB21605 INN or Proposed INN: desmopressin acetate trihydrate Other descriptive name: DESMOPRESSIN ACETATE TRIHYDRATE | Radboud University Nijmegen Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 11 | EUCTR2011-005970-41-NL (EUCTR) | 27/02/2012 | 08/02/2012 | The effect of the drug acetazolamide on excessive urine production due to a diminished concentrating ability of the kidney as a result of the use of lithium in patients with an affective disorder: a pilot study | The effect of acetazolamide on lithium-induced nephrogenic diabetes insipidus in patients with an affective disorder: a pilot study | lithium-induced nephrogenic diabetes insipidus MedDRA version: 14.1;Level: LLT;Classification code 10012600;Term: Diabetes insipidus nephrogenic;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1;Classification code 10050501;Term: Lithium toxicity;System Organ Class: 10022117 - Injury, poisoning and procedural complications;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Acetazolamide Sandoz 250 Other descriptive name: ACETAZOLAMIDE | Radboud University Nijmegen Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 12 | EUCTR2006-003360-56-DK (EUCTR) | 28/08/2009 | 07/07/2009 | Farmakologisk behandling af CNDI – Et ”proof-of-concept” studie. - NDI-POC-STUDY | Farmakologisk behandling af CNDI – Et ”proof-of-concept” studie. - NDI-POC-STUDY | Kongenit nefrogen diabetes insipidus MedDRA version: 14.1;Level: PT;Classification code 10068304;Term: Congenital nephrogenic diabetes insipidus;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: Confortid INN or Proposed INN: INDOMETACIN Trade Name: Losec INN or Proposed INN: OMEPRAZOLE MAGNESIUM Trade Name: Viagra Other descriptive name: SILDENAFIL CITRATE Trade Name: Miacalcic Other descriptive name: CALCITONIN (SALMON) Trade Name: Spirix Other descriptive name: SPIRONOLACTONE Trade Name: Esidrix Product Name: Esidrix INN or Proposed INN: HYDROCHLOROTHIAZIDE | Dept. of Pediatrics, The Childrens Hospital, Denver | NULL | Not Recruiting | Female: no Male: yes | 40 | Denmark | |||
| 13 | NCT00478335 (ClinicalTrials.gov) | May 2007 | 23/5/2007 | Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus | Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus | Nephrogenic Diabetes Insipidus | Drug: sildenafil;Drug: calcitonin;Drug: hydrochlorothiazide/amiloride;Drug: indomethacin;Drug: Placebo for sildenafil;Drug: placebo for calcitonin | University of Colorado, Denver | University of Aarhus | Completed | 5 Years | 25 Years | Male | 4 | N/A | United States;Denmark |
| 14 | EUCTR2006-001202-84-NL (EUCTR) | 01/02/2007 | 31/01/2007 | Comparison of the action of amiloride and thiazide in the reduction of lithium-NDI in patients with affective disorders - Treatment lithium-NDI | Comparison of the action of amiloride and thiazide in the reduction of lithium-NDI in patients with affective disorders - Treatment lithium-NDI | Lithium-induced Nephrogenic Diabetes Insipidus MedDRA version: 9.1;Level: LLT;Classification code 10012600;Term: Diabetes insipidus nephrogenic | Trade Name: Midamor Product Name: Amiloride Trade Name: Hydrochloorthiazide Product Name: hydrochloorthiazide | Radboud University Nijmegen Medical Centre | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 4 | Netherlands | ||
| 15 | NCT00004360 (ClinicalTrials.gov) | September 1995 | 18/10/1999 | Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus | Diabetes Insipidus, Nephrogenic | Drug: chlorothiazide | National Center for Research Resources (NCRR) | Northwestern University | Completed | 6 Months | 70 Years | Both | N/A | NULL |