[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100233152":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":32,"centralContacts":28,"locations":36,"responsibleParty":58,"collaborators":28,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":28,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":28,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":86,"whyStopped":28,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively)",[13],"Drug: Molidustat(BAY85-3934)",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2","Single oral dose of 75 mg molidustat (fasted) in subjects on peritoneal dialysis (after start of peritoneal dialysis intervall and, optionally, after the start of a peritoneal dialysis-free intervall,respectively)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Arm 3","Single oral dose of 75 mg molidustat (fasted) in healthy subjects",[13],[23,29],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Molidustat(BAY85-3934)","Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis",[9,15],null,{"type":24,"name":25,"description":30,"armGroupLabels":31,"otherNames":28},"One single oral dose of 75 mg molidustat in healthy subjects",[19],[33],{"name":34,"affiliation":5,"role":35},"Bayer Study Director","STUDY_DIRECTOR",[37,49],{"facility":28,"status":28,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":28},"Velbert","North Rhine-Westphalia","42549","Germany","DE",{"type":44,"coordinates":45},"Point",[46,47],7.04348,51.33537,{"lat":47,"lon":46},{"facility":28,"status":28,"city":50,"state":51,"zip":52,"country":41,"countryCode":42,"cosmosGeoPoint":53,"geoPoint":57,"contacts":28},"Kiel","Schleswig-Holstein","24105",{"type":44,"coordinates":54},[55,56],10.13489,54.32133,{"lat":56,"lon":55},{"type":59,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100233152","phase-1-to-investigate-pharmacokinetics-absorption-distribution-elimination-safety-and-tolerability-of-a-single-oral-dose-of-75-mg-molidustat-tablet-in-male-and-female-subjects-requiring-hemo--or-peritoneal-dialysis-compared-to-healthy-subjects-100233152",false,"NCT02312973","To Investigate Pharmacokinetics (Absorption, Distribution, Elimination), Safety and Tolerability of a Single Oral Dose of 75 mg Molidustat Tablet in Male and Female Subjects Requiring Hemo- or Peritoneal Dialysis Compared to Healthy Subjects","Investigation of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Oral Doses of 75 mg Molidustat in Male and Female Subjects With Renal Impairment Requiring Hemo- or Peritoneal Dialysis Compared to Age- and Weight-matched Healthy Subjects in a Single-center, Non-controlled, Non-blinded Study With Group Stratification","Inclusion Criteria:\n\n* Male and female (without childbearing potential)\n* Age: ≥18 and ≤79 years of age\n* Body mass index (BMI): ≥18 and ≤34 kg\u002Fm2\n* Ethnicity: White\n* Subjects with severe renal impairment on hemodialysis or peritoneal dialysis, and\n* Healthy subjects\n\nExclusion Criteria:\n\n* Women of childbearing potential, pregnant or lactating women\n* Use of medication within the 2 weeks preceding the study which could interfere with the investigational product\n* Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab), human immune deficiency virus 1 and 2 antibodies (HIV 1\u002F2 Ab)\n* Exclusion periods from other studies or simultaneous participation in other clinical studies",true,"ALL","18 Years","79 Years",{"count":72,"type":73},40,"ACTUAL","INTERVENTIONAL",[76],"PHASE1","The study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as the safety and tolerability of molidustat.",[79],"Renal Insufficiency, Chronic",[81,82,83,84,85],"Chronic kidney disease","Pharmacokinetics","Hemodialysis","Peritoneal dialysis","Erythropoietin","COMPLETED","2021-01-22",{"date":89,"type":73},"2021-01-25",{"date":91,"type":73},"2015-01-14",{"date":93,"type":73},"2016-06-01",{"name":5,"class":6},2]