ACEi ARB Withdrawal in CKD Patients

NCT03957161 | Withdrawn DMC

• 1 other identifier: 18-25554
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Rate of enrollment and dropout in trial

  measure of acceptability of continuing ACEi/ARBs among providers and patients

  Months 1-12

• Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L)

  safety measure

  Months 1-12

• Number of all cause emergency room visits

  safety measure

  Months 1-12

• Number of all-cause hospitalizations

  safety measure

  Months 1-12

• Number of falls and syncope reported by patients and/or discharge summaries

  safety measure

  Months 1-12

• Number of patients who receive chronic dialysis or kidney transplant

  Marks the onset of end-stage renal disease

  Months 1-12

Study Arms (2)

ACEi/ARB continuation

EXPERIMENTAL

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

Other: Continuation of ACEi and/or ARBs

ACEi/ARB withdrawal

NO INTERVENTION

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

Continuation of ACEi and/or ARBs OTHER

Patients will continue or start taking ACEi and/or ARBs

ACEi/ARB continuation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elaine Ku, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 21, 2019
• Study Start: November 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)