Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-06 @ 5:11 AM
Study NCT ID:
NCT03957161
Status:
WITHDRAWN
Last Update Posted:
2023-11-18
First Post:
2019-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACEi ARB Withdrawal in CKD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Currently we are not pursuing this trial due t o limited bandwidth and have not enrolled any participants.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2019-05-15', 'studyFirstSubmitQcDate': '2019-05-20', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of enrollment and dropout in trial', 'timeFrame': 'Months 1-12', 'description': 'measure of acceptability of continuing ACEi/ARBs among providers and patients'}, {'measure': 'Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L)', 'timeFrame': 'Months 1-12', 'description': 'safety measure'}, {'measure': 'Number of all cause emergency room visits', 'timeFrame': 'Months 1-12', 'description': 'safety measure'}, {'measure': 'Number of all-cause hospitalizations', 'timeFrame': 'Months 1-12', 'description': 'safety measure'}, {'measure': 'Number of falls and syncope reported by patients and/or discharge summaries', 'timeFrame': 'Months 1-12', 'description': 'safety measure'}, {'measure': 'Number of patients who receive chronic dialysis or kidney transplant', 'timeFrame': 'Months 1-12', 'description': 'Marks the onset of end-stage renal disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease', 'Blood Pressure', 'Angiotensin-converting Enzyme Inhibitor', 'Angiotensin Receptor Blockers']}, 'descriptionModule': {'briefSummary': 'The American Heart Association guidelines for high blood pressure (BP) currently recommend using angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) as first-line therapy for patients with chronic kidney disease (CKD) stage 3 or above. However, the prevalence of ACEi and ARB use in patients with CKD stage 4 or 5 is low, and current BP guidelines acknowledge the lack of solid evidence to support the benefit of using these agents in advanced CKD.This study seeks to conduct a pilot trial to determine the safety and feasibility of ACEi and/or ARB continuation (intervention) versus withdrawal (control) in patients with advanced CKD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults ≥18 years of age who meet the eGFR eligibility criteria, which will be determined based on whether participants have at least two eGFR in the last three months that are \\< 25 mL/min/1.73m2 or prior diagnosis of CKD (per electronic chart review) and at least one eGFR \\< 25 mL/min/1.73m2 in the past six months\n* receiving at least one antihypertensive medication at the time of the screening visit.\n\nExclusion Criteria:\n\nThe investigators will exclude those who:\n\n* are or are planning to become pregnant, due to inability to take multiple classes of anti-hypertensive agents\n* are marginally housed, due to concerns regarding routine follow-up\n* are actively participating in a different interventional trial that may affect blood pressure\n* are unwilling to consent to participate\n* institutionalized individuals or prisoners\n* are actively abusing illicit drugs or alcohol\n* have a history of poor or doubtful compliance (e.g., frequently missed appointments)\n* have cognitive impairment prohibiting participation in the study\n* on dialysis at time of recruitment'}, 'identificationModule': {'nctId': 'NCT03957161', 'briefTitle': 'ACEi ARB Withdrawal in CKD Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Angiotensin-converting Enzyme Inhibitors (ACEi) or Angiotensin Receptor Blockers (ARB) Withdrawal in Patients With Advanced Chronic Kidney Disease', 'orgStudyIdInfo': {'id': '18-25554'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACEi/ARB continuation', 'description': 'Intervention group will continue or start to take ACEi and/or ARBs', 'interventionNames': ['Other: Continuation of ACEi and/or ARBs']}, {'type': 'NO_INTERVENTION', 'label': 'ACEi/ARB withdrawal', 'description': 'The control group will discontinue ACEi and/or ARBs which may be substituted with other anti-hypertensive agents (if already taking ACEi/ARB) or continue to not take ACEi/ARBs'}], 'interventions': [{'name': 'Continuation of ACEi and/or ARBs', 'type': 'OTHER', 'description': 'Patients will continue or start taking ACEi and/or ARBs', 'armGroupLabels': ['ACEi/ARB continuation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Elaine Ku, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}