[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07734636":3,"trial-entities:NCT07734636":106,"trial-summary:NCT07734636":110},{"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":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":41,"secondary_outcomes":46,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":81,"locations":84,"central_contacts":99,"overall_officials":101,"references":104,"see_also_links":105},"NCT07734636","25-45052","A Prompt REstart Study of Renin-Angiotensin System Inhibitors After Acute Kidney Injury","NOT_YET_RECRUITING","2029-03","2026-07","2026-07-29","2026-08","University of California, San Francisco","OTHER",true,"The goal of this pilot clinical trial is to learn if early restart of renin-angiotensin system inhibitor (RASi) medications is feasible and well-tolerated in hospitalized patients with acute kidney injury (AKI). Researchers will compare early RASi restart to usual care.\n\nStudy participants will restart RASi per study protocol, obtain a lab test in 1-2 weeks if RASi restarted in the hospital and not collected as part of routine care, and answer questions at the 90-day follow-up.","Among at-risk patients with heart failure and chronic kidney disease, use of RASi medications decreases the subsequent risk of adverse events such as cardiovascular death and kidney disease progression. However, RASi treatment is often stopped when AKI is detected in the hospital based on the notion that restoring an intact renin-angiotensin system in the context of hypovolemia or hypotension may be helpful to maintain perfusion to the glomeruli and thus support the glomerular filtration rate.\n\nIn observational studies, restart of RASi medications among at-risk patients after AKI has been associated with decreased subsequent rates of mortality, cardiovascular events, and kidney disease progression. However, there is no rigorous evidence from randomized trials to guide optimal strategy of RASi restart after AKI.\n\nThis is a pilot trial among hospitalized patients with AKI whose RASi were held to investigate the feasibility and tolerability of a strategy of early RASi restart (n=30) compared to usual care (n=30). This pilot trial will provide valuable data critical to inform the design of a larger definitive trial.\n\nThe study hypothesis is that the strategy of early RASi restart after AKI is feasible and well-tolerated. This pilot trial will inform the design of a larger definitive trial to determine whether early RASi restart can increase rates of RASi use at 90 days compared to usual care.",[18],"Acute Kidney Injury",[20],"Acute kidney injury","INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},60,"ESTIMATED",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Early RASi restart strategy","The early restart strategy is to resume RASi as soon as the serum creatinine (SCr) downtrends by ≥0.3mg\u002FdL from peak. In addition, the following criteria must be met: most recent potassium ≤5mEq\u002FL, CKD-EPI SCr-based eGFR reported as ≥15 mL\u002Fmin\u002F1.73m2, and average SBP ≥120mmHg 12 hours prior to restart. If the study participant is discharged from the hospital before the RASi restart criteria are met, management of RASi restart would be deferred to the discretion of longitudinal outpatient healthcare team.",[31],[35],"renin-angiotensin system inhibitors",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Usual Care","RASi restart will be deferred to the study participant's providers.",[40],"Usual care",[42],{"measure":43,"description":44,"timeFrame":45},"Feasibility- RASi use separation","Proportion of patients in the early RASi restart arm and the usual care arm who restart RASi within 72 hours of SCr downtrending by ≥0.3mg\u002FdL from peak SCr and at hospital discharge","From date of enrollment until date of hospital discharge or up to 90 days if remains in the hospital",[47,51,55,58],{"measure":48,"description":49,"timeFrame":50},"Tolerability- 90 day follow up completion","Proportion of participants who complete 90 day follow up","Up to 90 days",{"measure":52,"description":53,"timeFrame":54},"Tolerability- Lab evaluation post RASi","Proportion with potassium and SCr evaluations within 1-2 weeks of RASi restart","Up to 2 weeks post hospital discharge or 90 days if patient remains in the hospital",{"measure":56,"description":57,"timeFrame":50},"Tolerability- SCr evaluation after hospital discharge","Proportion with SCr evaluation after hospital discharge",{"measure":59,"description":60,"timeFrame":50},"Tolerability- Proteinuria evaluation","Proportion with proteinuria evaluation after hospital discharge","ALL","18 Years",null,false,{"inclusion":66,"exclusion":71,"raw_text":80},[67,68,69,70],"Age ≥ 18 years","Pre-admission RASi use for Class I indication (e.g., heart failure, kidney disease)","RASi stopped in the setting of AKI (defined by ≥1.5x baseline SCr)","AKI in recovery (defined by a decrease in SCr by ≥0.3mg\u002FdL from peak)",[72,73,74,75,76,77,78,79],"RASi allergy or contraindication (i.e., angioedema, bilateral renal artery stenosis)","Ongoing dialysis requirement","Pregnant or breastfeeding","Prisoner","Palliative or hospice care involvement","Unable to consent","No enteral route of medication administration","Clinician judgment","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Pre-admission RASi use for Class I indication (e.g., heart failure, kidney disease)\n* RASi stopped in the setting of AKI (defined by ≥1.5x baseline SCr)\n* AKI in recovery (defined by a decrease in SCr by ≥0.3mg\u002FdL from peak)\n\nExclusion Criteria:\n\n* RASi allergy or contraindication (i.e., angioedema, bilateral renal artery stenosis)\n* Ongoing dialysis requirement\n* Pregnant or breastfeeding\n* Prisoner\n* Palliative or hospice care involvement\n* Unable to consent\n* No enteral route of medication administration\n* Clinician judgment",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":12,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":96},"San Francisco","California","94143","United States",[91],{"name":92,"role":93,"phone":94,"email":95},"Yuenting D Kwong, MD MAS","CONTACT","415-514-7371","diana.kwong@ucsf.edu",{"lat":97,"lon":98},37.77493,-122.41942,[100],{"name":92,"role":93,"phone":94,"email":95},[102],{"name":92,"affiliation":12,"role":103},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":107,"biomarkers":109},[108],"Acute Renal Failure",[],{"nct_id":4,"found":14,"summary":111,"prompt_version":121},{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This is a pilot interventional study with 60 participants. It compares two groups: one receiving an early RASi restart and another receiving usual care.","completed","Early Restart of RAS Inhibitors After Acute Kidney Injury","This study is looking at whether it's safe and practical to restart certain blood pressure medications, called Renin-Angiotensin System Inhibitors (RASi), sooner after a patient has acute kidney injury (AKI). Researchers will compare an \"early RASi restart strategy\" to \"usual care\" where doctors decide when to restart the medication. You may be able to join if you are 18 or older, were taking RASi before your hospital stay for conditions like heart failure or kidney disease, and your RASi was stopped due to AKI. The main goal is to see if restarting RASi early is feasible. The study is currently unclear on its recruitment status.","Participants will be followed up to 90 days after enrollment or hospital discharge.",105,"If you join, you will restart RASi according to the study plan, have a lab test 1-2 weeks after restarting if not part of routine care, and answer questions at a 90-day follow-up.","Not stated in the trial record.",[31,37],"v2"]