[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05671991":3,"trial-entities:NCT05671991":90,"trial-summary:NCT05671991":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":13,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":44,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":14,"eligibility_criteria":67,"std_ages":71,"locations":74,"central_contacts":83,"overall_officials":84,"references":88,"see_also_links":89},"NCT05671991","2000031605","Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease","ACTIVE_NOT_RECRUITING","2026-12-31","2026-09","2026-09-14","2023-03-01","Yale University","OTHER",false,"The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis.\n\nThis is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week \"pre post\" open label extension in all 30 patients where they will receive empagliflozin daily.","Participants will undergo three study visits, and up to 4 safety visits, over 9 weeks.\n\nAt 7 AM in the first study visit, the participants will have taken 25mg empagliflozin once or matching placebo, thus producing peak plasma levels by 10 AM. One week later the participant will return for the crossed over to the alternate study drug.\n\nAt the conclusion of the 2nd study visit, all participants will be provided with empagliflozin 10mg tabs to be taken daily for 56 days (8 weeks). At each study visit and safety visit, participants will undergo a PET test.",[18],"End Stage Renal Disease on Dialysis",[20],"Peritoneal dialysis","INTERVENTIONAL",[23],"PHASE4",{"count":25,"type":26},22,"ACTUAL",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","Empagliflozin 25 mg vs Placebo","Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7",[33],"Empagliflozin or Placebo in Acute",{"type":29,"name":35,"description":36,"armGroupLabels":37},"Empagliflozin 10 MG","Chronic Study- Empagliflozin 10 mg for 8 weeks",[38],"Empagliflozin in Chronic",[40],{"measure":41,"description":42,"timeFrame":43},"Glucose absorption with empagliflozin vs. placebo","Total glucose absorption in grams with empagliflozin vs. placebo","Day 0 to Day 63",[45,49,52,55,58,61],{"measure":46,"description":47,"timeFrame":48},"Ultrafiltration volume with empagliflozin vs. placebo- acute study","Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo.","at 4 hours",{"measure":50,"description":51,"timeFrame":43},"Change in plasma glucose levels with empagliflozin vs. placebo- acute study","Change in plasma glucose levels during PD dwell with empagliflozin vs. placebo- acute study",{"measure":53,"description":54,"timeFrame":43},"Increase in natriuresis with empagliflozin vs. placebo-acute study","Natriuresis determined by FENa",{"measure":56,"description":57,"timeFrame":43},"Change in peritoneal fluid inflammatory markers","Change in levels of IL-6 and CA-125 (in pg)",{"measure":59,"description":60,"timeFrame":43},"Change in PET test parameters","Change in peritoneal equilibration test parameters, measurement of solute transport across the peritoneal membrane (standard test carried out in PD patients to assess solute trasnport across membrane)",{"measure":62,"description":63,"timeFrame":43},"Change in total body water and extracellular water","Change in total body water and extracellular water, using heaving water (D20)","ALL","18 Years",null,{"inclusion":68,"exclusion":69,"raw_text":70},[],[],"Inclusion Criteria\n\n1. Patients actively undergoing PD with a reliably functioning PD catheter\n2. Stable peritoneal dialysis prescription\n3. PD vintage \\> 3 months\n4. Age \\>18 years of age\n\nExclusion Criteria:\n\n1. History of type 1 diabetes, diabetic ketoacidosis, \"brittle\" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months\n2. Use of an SGLT2 inhibitor within the prior 30 days\n3. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter\n4. Anemia with hemoglobin \\\u003C8g\u002FdL\n5. Inability to give written informed consent or follow study protocol\n6. Contraindication to receiving loop diuretics",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":12,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"New Haven","Connecticut","06510","United States",{"lat":81,"lon":82},41.30815,-72.92816,[],[85],{"name":86,"affiliation":12,"role":87},"Jeffrey Testani, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":91,"biomarkers":94},[92,93],"Chronic Kidney Disease, Stage 5","Peritoneal Dialysis",[],{"nct_id":4,"found":96,"summary":97,"prompt_version":107},true,{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is a randomized, placebo-controlled study with an initial crossover phase, followed by an open-label extension. About 30 participants will be involved.","completed","Empagliflozin for Peritoneal and Kidney Function in End Stage Renal Disease","This study is looking at how a medication called empagliflozin (25 mg or 10 mg) affects people with End Stage Renal Disease (ESRD) who are on peritoneal dialysis (PD). The main goal is to see if empagliflozin can reduce how much sugar (glucose) is absorbed in your belly (peritoneum). You might be able to join if you are over 18, have been on PD for more than 3 months, and have a working PD catheter. People with certain types of diabetes or frequent low blood sugar are not able to join. This study is currently unclear about its recruitment status and plans to enroll about 30 participants.","The primary endpoint, glucose absorption, is measured from Day 0 to Day 63.",107,"You will have three main study visits and up to four safety visits over nine weeks. You will take empagliflozin or a placebo, and undergo a PET test at each visit.","Not stated in the trial record.",[],"v2"]