ACEi ARB Withdrawal in CKD Patients

Not Applicable

Withdrawn

• Conditions: Angiotensin Receptor Blockers; Blood Pressure; Angiotensin-converting Enzyme Inhibitor; Chronic Kidney Disease
• Interventions: Other: Continuation of ACEi and/or ARBs

• Registration Number: NCT03957161
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-21
• Status Verified: 2023-11
• Study Start: 2023-11
• Primary Completion: 2023-11
• Study Completion: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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
• receiving at least one antihypertensive medication at the time of the screening visit.

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Exclusion Criteria

The investigators will exclude those who:

• are or are planning to become pregnant, due to inability to take multiple classes of anti-hypertensive agents
• are marginally housed, due to concerns regarding routine follow-up
• are actively participating in a different interventional trial that may affect blood pressure
• are unwilling to consent to participate
• institutionalized individuals or prisoners
• are actively abusing illicit drugs or alcohol
• have a history of poor or doubtful compliance (e.g., frequently missed appointments)
• have cognitive impairment prohibiting participation in the study
• on dialysis at time of recruitment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACEi/ARB continuation	Continuation of ACEi and/or ARBs	Intervention group will continue or start to take ACEi and/or ARBs

Primary Outcome Measures

Name	Time	Method
Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L)	Months 1-12	safety measure
Number of all cause emergency room visits	Months 1-12	safety measure
Number of falls and syncope reported by patients and/or discharge summaries	Months 1-12	safety measure
Number of patients who receive chronic dialysis or kidney transplant	Months 1-12	Marks the onset of end-stage renal disease
Number of all-cause hospitalizations	Months 1-12	safety measure
Rate of enrollment and dropout in trial	Months 1-12	measure of acceptability of continuing ACEi/ARBs among providers and patients

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States