[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458439":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":35,"responsibleParty":53,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":30,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":30,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":38,"whyStopped":30,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"St. Louis University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"treatment","EXPERIMENTAL","JATENZO daily for 6 months",[13],"Drug: Jatenzo Pill",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Jatenzo Pill","oral tablet daily",[9],[21],"oral testosterone",[23],{"name":24,"affiliation":5,"role":25},"Sandeep Dhindsa, MD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","314-977-9320",null,"sandeep.dhindsa@health.slu.edu",{"name":33,"role":28,"phone":30,"phoneExt":30,"email":34},"Jennifer Newman, RN","jennifer.newman@heath.slu.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Saint Louis Univeristy","RECRUITING","St Louis","Missouri","63104","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-90.19789,38.62727,{"lat":48,"lon":47},[51],{"name":52,"role":28,"phone":30,"phoneExt":30,"email":30},"Jennifer Newman",{"type":25,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Sandeep Singh Dhindsa, M.D.","Professor of Medicine",[57],{"name":58,"class":59},"Clarus Therapeutics, Inc.","INDUSTRY","100458439","phase-2-testosterone-treatment-in-men-with-chronic-kidney-disease-100458439",false,"NCT05249634","Testosterone Treatment in Men With Chronic Kidney Disease","Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease","Inclusion Criteria:\n\n* Men between ages of 18-85 years of age\n* eGFR 15-45 ml\u002Fmin\u002F1.73m2 by MDRD (Modification of Diet in Renal Disease) equation\n* Subnormal total serum T concentrations (\\\u003C300 ng\u002Fdl) on two separate occasions in morning\n* Symptoms of hypogonadism (as per Endocrine Society guidelines): low libido, erectile dysfunction, fatigue, irritability, depressed mood, poor concentration, increased body fat, decreased muscle bulk, reduced physical performance, sleep disturbance, loss of body hair (15)\n* Normal iron stores as defined by serum ferritin ≥100 ng\u002FmL and transferrin saturation (TSAT) ≥20%.\n\nExclusion Criteria:\n\n* Use of TRT currently or in the past 6 months, including use of over-the-counter androgen containing health supplements (e.g., DHEA)\n* Hematocrit \\>48% (as per Endocrine Society guidelines)(15)\n* Treatment with erythropoiesis stimulating agents (ESA)\n* Uncontrolled blood pressure (\\>180\u002F100 mm Hg)\n* Heart Failure, class III or IV\n* Myocardial infarction, stroke, or heart surgery in the past 3 months\n* Breast cancer\n* History of prostate cancer\n* Prostate specific antigen (PSA) \\>4 ng\u002Fml, unless prostate cancer has been ruled out by a urologist (documented in physician notes)\n* HIV or untreated hepatitis C\n* Untreated, severe obstructive sleep apnea\n* Initiated iron replacement in the last 3 months\n* deep venous thrombosis or pulmonary embolism in the last 3 months\n* recurrent (more than once) deep venous thrombosis or pulmonary embolism\n* use of warfarin\n* Planning to have children in the next one year","MALE","18 Years","85 Years",{"count":71,"type":72},20,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This study in being conducted in men who have low testosterone and chronic kidney disease. The investigators will evaluate the effects of an oral testosterone preparation, JATENZO, on testosterone levels and hemoglobin (red blood cells).",[78,79],"Hypogonadism, Male","Kidney Disease, Chronic",[81,82],"testosterone","CKD","2026-04-24",{"date":85,"type":86},"2026-04-30","ACTUAL",{"date":88,"type":86},"2022-03-15",{"date":90,"type":72},"2028-12",{"name":5,"class":6},1]