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Currently we are not pursuing this trial due t o limited bandwidth and have not enrolled any participants.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACEi/ARB continuation | Experimental | Intervention group will continue or start to take 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuation of ACEi and/or ARBs | Other | Patients will continue or start taking ACEi and/or ARBs |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The investigators will exclude those who:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine Ku, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |