[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475140":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":64,"collaborators":43,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":43,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":43,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Medical University of Bialystok","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","0,3ug\u002Fkg in 100ml 0,9% NaCl managed as intravenous infusion;",[13,14],"Drug: Desmopressin","Drug: intravenous infusion NaCl",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo comparator","PLACEBO_COMPARATOR","0,9% NaCl managed as intravenous infusion;",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Desmopressin","desmopressin 0,3ug\u002Fkg in 100ml 0,9% NaCl managed as intravenous infusion;",[9],[27],"Minirin",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"intravenous infusion NaCl","0,9% NaCl managed as intravenous infusion",[9,16],[33],"0,9% NaCl",[35],{"name":36,"affiliation":37,"role":38},"Alicja Rydzewska-Rosołowska, Assoc.Prof.","Second Department of Nephrology and Hypertension with Dialysis Unit","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","+48 604 330 187",null,"alicja.rydzewska-rosolowska@umb.edu.pl",[46],{"facility":47,"status":48,"city":49,"state":43,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"II Department of Nephrology and Hypertension","RECRUITING","Bialystok","15-276","Poland","PL",{"type":54,"coordinates":55},"Point",[56,57],23.16433,53.13333,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":62,"phoneExt":43,"email":63},"Alicja Rydzewska-Rosolowska, MD","+48858317885","alicja.rosolowska@umb.edu.pl",{"type":65,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100475140","phase-3-safety-outcomes-post-kidney-biopsy---randomized-clinical-evaluation-of-efficacy-of-desmopressin-100475140",false,"NCT05467033","Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin","STOP-BLEED","Inclusion Criteria:\n\n1. ≥ 18 years old\n2. Ability to provide Informed Consent\n3. Qualification by nephrologist to kidney biopsy in accordance to current standards\n4. Initial haemoglobin concentration \\> 8g\u002Fdl and PLT count \\>100 x103\u002FμL\n5. Normal range of APTT and INR\n6. Blood pressure control defined as SBP\\\u003C160 mmHg\n7. Permitted antiplatelet\u002Fantithrombotic drugs: acetylsalicylic acid and heparin\n8. No inflammation at the point of biopsy needle insertion\n\nExclusion Criteria:\n\n1. Initial sodium concentration \\\u003C130mmol\u002Fl\n2. Pregnancy and breastfeeding\n3. Anaphylactic shock after desmopressin administration (medical history)\n4. Necessity of administration other anti-platelet \u002F anti thrombotic drugs other than acetylsalicylic acid, non-fractionated heparin or low molecular weight heparin\n5. Decompensated Heart failure\n6. Von Willebrand disease (VWD) type II B\n7. As per Investigator opinion a medical situation which may lead to increased intracranial pressure (ICP)\n8. Hydronephrosis of the biopsied kidney\n9. Usage of any prohibited drug before screening :\n\n   * ASA in dosage \\> 75mg per day\n   * Vitamin K antagonist (VKA)\n   * Direct oral anticoagulants (DOAC)\n   * Low-molecular-weight heparin (LMWH)\n   * Unfractionated heparin (UFH)\n   * Except situation when dosage of listed above drugs will be adjusted in accordance to protocol","ALL","18 Years","99 Years",{"count":77,"type":78},424,"ESTIMATED","INTERVENTIONAL",[81],"PHASE3","It is a randomized, multicenter, double-blind, placebo controlled, interventional clinical trial that will be conducted in Poland, in about 6 Hospital Nephrology Departments to evaluate the safety and effectiveness of desmopressin on the prevention of bleeding after percutaneous needle kidney biopsy in patients with rare and ultrarare glomerulonephritis.",[84],"Kidney Biopsy","2025-05-05",{"date":87,"type":88},"2025-05-08","ACTUAL",{"date":90,"type":88},"2022-09-01",{"date":92,"type":78},"2026-08-31",{"name":5,"class":6},1]