ACEi ARB Withdrawal in CKD Patients

Chronic Kidney Disease Clinical Trial

Official title:

Angiotensin-converting Enzyme Inhibitors (ACEi) or Angiotensin Receptor Blockers (ARB) Withdrawal in Patients With Advanced Chronic Kidney Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03957161
• Other study ID #: 18-25554
• Status: Withdrawn
• Phase: N/A
• Start date: November 2023
• Est. completion date: November 2023

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angiotensin Receptor Blockers
• Angiotensin-converting Enzyme Inhibitor
• Blood Pressure
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Continuation of ACEi and/or ARBs
Patients will continue or start taking ACEi and/or ARBs

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

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