[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07064174":3,"trial-entities:NCT07064174":89,"trial-summary:NCT07064174":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":38,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":56,"locations":59,"central_contacts":84,"overall_officials":86,"references":87,"see_also_links":88},"NCT07064174","STU-2022-1024","Sickle Cell Kidney Biorepository","Sickle Cell Kidney (SCeK) Biorepository","RECRUITING","2049-12","2026-04","2026-04-13","2024-08-22","University of Texas Southwestern Medical Center","OTHER",false,"Kidney disease is a major cause of illness and death in people with sickle cell disease and sickle cell trait. Despite these concerning facts, we do not (1) have an in-depth understanding of how kidney disease starts in sickle cell disease and sickle cell trait, (2) have detailed insights into why kidney disease is worse in people with sickle cell disease and sickle cell trait, (3) have management options that are tailored to treating or preventing kidney disease in people with sickle cell disease or sickle cell trait.\n\nThe SCeK Biorepository is a specialized, secure repository designed for the collection of blood and urine samples from people with sickle cell disease and sickle cell trait. These samples are connected to detailed medical records, with the sole purpose of allowing researchers to better understand how kidney disease starts and progresses in people with the sickle cell gene. By studying these stored samples (using new tests) together with health information, researchers can find better early warning signs of kidney injury and develop better ways to protect kidney health in people with sickle cell disease and sickle cell trait.","Chronic kidney disease is one of the most common causes of morbidity and mortality in sickle cell disease, occurring at a much earlier age and with a far higher frequency as compared to the general population. Furthermore, sickle cell trait has emerged as an under-recognized major risk factor for chronic kidney disease.\n\nDespite the seriousness of these findings, there are significant gaps in our understanding of the pathophysiology of and risk factors for incident chronic kidney disease and chronic kidney disease progression in both sickle cell disease and sickle cell trait.\n\nThe UT Southwestern and Parkland Health Sickle Cell Kidney (SCeK) Biorepository aims to address these knowledge gaps by collecting well annotated, high quality dedicated bio-samples integrated with routine clinical data to facilitate improved prognostication, provide mechanistic insights, and form the basis for the investigation of novel therapeutic options.",[19,20,21],"Sickle Cell Trait","Sickle Cell Disease (SCD)","Chronic Kidney Disease",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},800,"ESTIMATED",[],[31,35],{"measure":32,"description":33,"timeFrame":34},"Kidney function decline","Mean change in the estimated glomerular filtration rate per year","10 years",{"measure":36,"description":37,"timeFrame":34},"Albuminuria","Mean change in the urine albumin-to-creatinine ratio per year",[39,42,45],{"measure":40,"description":41,"timeFrame":34},"Mortality","Time to death over follow up period",{"measure":43,"description":44,"timeFrame":34},"Hospitalization rates","Frequency of hospitalizations and emergency room visits over follow up",{"measure":46,"description":47,"timeFrame":34},"Cardiovascular outcomes","Incident left ventricular hypertrophy, diastolic dysfunction, heart failure, pulmonary hypertension, or stroke.","ALL","18 Years","65 Years",true,{"inclusion":53,"exclusion":54,"raw_text":55},[],[],"Inclusion Criteria:\n\n1. Age over 18 years,\n2. Estimated glomerular filtration rate greater than or equal to 15 mL\u002Fmin,\n3. Presence of any hemoglobinopathy (will need to be confirmed by hemoglobin electrophoresis or genetic testing),\n4. Controls (absence of hemoglobinopathy) will be subject to review and only selected if demographics are identical to a currently enrolled participant with a hemoglobinopathy.\n\nExclusion Criteria:\n\n1. Age 66 years or older,\n2. Estimated glomerular filtration rate less than 15 mL\u002Fmin or on dialysis,\n3. Active pregnancy (may be enrolled 4 weeks or more after delivery),\n4. Active sickle cell pain episode requiring hospitalization or emergency room visit or pain infusion clinic visit (may be enrolled 2 weeks or more after resolution of severe pain),\n5. Active malignancy on induction or consolidation treatment. Maintenance chemotherapy in remission will be considered,\n6. Prisoners.",[57,58],"ADULT","OLDER_ADULT",[60,77],{"facility":61,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":74},"Parkland Memorial Hospital","Dallas","Texas","75235","United States",[67,72],{"name":68,"role":69,"phone":70,"email":71},"Kabir O Olaniran, MD, MPH, FASN","CONTACT","214-645-8267","SCeK@UTSouthwestern.edu",{"name":68,"role":73},"PRINCIPAL_INVESTIGATOR",{"lat":75,"lon":76},32.78306,-96.80667,{"facility":13,"status":8,"city":62,"state":63,"zip":78,"country":65,"contacts":79,"geoPoint":83},"75390",[80,82],{"name":81,"role":69,"phone":70,"email":71},"Kidney Clinical Research Office",{"name":68,"role":73},{"lat":75,"lon":76},[85],{"name":68,"role":69,"phone":70,"email":71},[],[],[],{"nct_id":4,"conditions":90,"biomarkers":92},[21,91,19],"Sickle Cell Disease",[93],"Hemoglobinopathy",{"nct_id":4,"found":51,"summary":95,"prompt_version":105},{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an observational study aiming to enroll up to 800 participants. It is not testing a specific drug or intervention.","completed","Sickle Cell Kidney Biorepository for Sickle Cell Disease and Trait","This study is creating a collection of blood and urine samples, called a biorepository, to better understand kidney disease in people with sickle cell disease (SCD) and sickle cell trait. Researchers want to learn how kidney disease starts and why it can be more severe in these conditions. This study is observational, meaning it collects information without testing new treatments. They plan to enroll up to 800 participants aged 18 to 65 who have sickle cell disease or sickle cell trait, and some control participants without these conditions. The main goals are to track changes in kidney function and albuminuria (a sign of kidney damage) over 10 years.","Participants' kidney function and albuminuria will be measured over 10 years.",108,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]