[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06790498":3,"trial-entities:NCT06790498":90,"trial-summary:NCT06790498":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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":70,"locations":73,"central_contacts":83,"overall_officials":84,"references":88,"see_also_links":89},"NCT06790498","REGEN-008S2","Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product","A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies REGEN-006, REGEN-007, and REGEN-015 (REGEN-008S2)","ENROLLING_BY_INVITATION","2030-08-31","2025-01","2025-01-24","2023-11-23","Prokidney","INDUSTRY",true,"The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or bilateral kidneys in previous studies.","This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 50 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (REGEN-007, REGEN-006, REGEN-015) will be monitored for up to five years with alternating in clinic and phone visits.",[19,20],"Diabetic Kidney Disease","Chronic Kidney Disease",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},50,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BIOLOGICAL","Renal Autologous Cell Therapy (REACT)","No interventions in this trial",[34],"CKD patients previously treated with REACT",[36],{"measure":37,"description":38,"timeFrame":39},"Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies.","Evaluation of the long-term safety of REACT will be assessed via:\n\n* Incidence of delayed serious adverse events (SAEs) obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.\n* Incidence of delayed biopsy-related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.\n* Incidence of delayed injection procedure related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.\n* Incidence of delayed investigational product related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.","60 months from completion of parent protocol EOS Visit",[41,44,47,49,51,53,56],{"measure":42,"description":43,"timeFrame":39},"Time from first injection to eGFR \u003C15 mL\u002Fmin\u002F1.73m² using the 2009 CKD-EPI serum creatinine equation.","Time from first injection to eGFR \\\u003C15 mL\u002Fmin\u002F1.73m² using the 2009 CKD-EPI serum creatinine equation.",{"measure":45,"description":46,"timeFrame":39},"Time from first injection to chronic dialysis.","Time from first injection to chronic dialysis",{"measure":48,"description":48,"timeFrame":39},"Time from first injection to renal transplant",{"measure":50,"description":50,"timeFrame":39},"Time from first injection to a cardiovascular death.",{"measure":52,"description":52,"timeFrame":39},"Time from first injection to a renal death.",{"measure":54,"description":55,"timeFrame":39},"Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD) at Months 12, 24, 36, 48, and 60.","Percent of participants who have the same or reduced 5-year risk of end stage renal",{"measure":57,"description":58,"timeFrame":39},"Percent of participants who have the same or reduced 2-year risk of end stage renal disease at Months 12, 24, 36, 48, and 60.","Percent of participants who have the same or reduced 2-year risk of end stage renal","ALL","30 Years","80 Years",false,{"inclusion":64,"exclusion":68,"raw_text":69},[65,66,67],"The participant must have received REACT in a previous trial (REGEN-006, REGEN- 007, and REGEN-015) for the treatment of chronic kidney disease and completed an end of study visit in their previous trial per protocol.","The participant is willing and able to cooperate with all aspects of the protocol.","The participant is willing and able to provide signed informed consent.",[],"Inclusion Criteria:\n\n* The participant must have received REACT in a previous trial (REGEN-006, REGEN- 007, and REGEN-015) for the treatment of chronic kidney disease and completed an end of study visit in their previous trial per protocol.\n* The participant is willing and able to cooperate with all aspects of the protocol.\n* The participant is willing and able to provide signed informed consent.\n\nExclusion Criteria:\n\n• Participant did not receive REACT in a previous trial for the treatment of chronic kidney disease",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Boise Kidney & Hypertension Institute","Meridian","Idaho","83642","United States",{"lat":81,"lon":82},43.61211,-116.39151,[],[85],{"name":86,"affiliation":13,"role":87},"Study Director","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":91,"biomarkers":93},[20,92],"Diabetic Nephropathy",[],{"nct_id":4,"found":62,"summary":23,"prompt_version":23}]