NCT05546099 Patient-driven Management of BP in CKD
| NCT ID | NCT05546099 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | VA Office of Research and Development |
| Condition | Chronic Kidney Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-12-15 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2022-12-15 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The proposed research will evaluate if patients managing their blood pressure medications under the guidance of a clinical pharmacist works better to lower blood pressure than patients monitoring their blood pressure at home and the standard care. 60 Veterans with chronic kidney disease (CKD) will be included in the study. The study will further evaluate factors that may influence the Veteran to accept the self-management approach and what factors in the VHA healthcare system affect the implementation of the self-management approach.
Eligibility Criteria
Inclusion Criteria: * Age \>= 18 years, * CKD stage 3 or 4 (estimated GFR: 15-59 mL/min/1.73m2) or * Stage 2 CKD (estimated GFR 60-89 mL/min/1.73m2) with urinary albumin/creatinine ratio (ACR 300 mg/g if no DM and 30 mg/g if with DM), and * Uncontrolled hypertension defined as the avg of 2 readings \> 140 systolic. Exclusion Criteria: * Severely uncontrolled hypertension defined as systolic BP \>180, * Patients with resistant hypertension and taking 4 BP medications, * Orthostatic hypotension defined as reduced systolic BP by 20 mmHg or diastolic BP by 10 mmHg after 3 minutes of standing, * Severe CKD defined as estimated GFR \< 20 mL/min/1.73m2, * Life expectancy \<1 year, * Severe liver disease, * Severe congestive heart failure, * Severe cognitive decline due to dementia, * Pregnant, breastfeeding, or unwilling to use adequate birth control
Contact & Investigator
Diana Jalal, MD
PRINCIPAL INVESTIGATOR
Iowa City VA Health Care System, Iowa City, IA
Frequently Asked Questions
Who can join the NCT05546099 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05546099 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT05546099 currently recruiting?
Yes, NCT05546099 is actively recruiting participants. Contact the research team at diana.jalal@va.gov for enrollment information.
Where is the NCT05546099 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT05546099 clinical trial?
NCT05546099 is sponsored by VA Office of Research and Development. The principal investigator is Diana Jalal, MD at Iowa City VA Health Care System, Iowa City, IA. The trial plans to enroll 160 participants.
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