ACEi ARB Withdrawal in CKD Patients

NCT ID: NCT03957161

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2023-11-30

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.

Conditions

Chronic Kidney Disease; Blood Pressure; Angiotensin-converting Enzyme Inhibitor; Angiotensin Receptor Blockers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ACEi/ARB continuation

Intervention group will continue or start to take ACEi and/or ARBs

Group Type: EXPERIMENTAL

Continuation of ACEi and/or ARBs

Intervention Type: OTHER

Patients will continue or start taking ACEi and/or ARBs

ACEi/ARB withdrawal

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuation of ACEi and/or ARBs

Patients will continue or start taking ACEi and/or ARBs

Intervention Type: OTHER

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elaine Ku, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

18-25554

Identifier Type: -

Identifier Source: org_study_id