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Self-Managed Blood Pressure Control for Chronic Kidney Disease

Phase 3

Recruiting

Led By Diana Jalal, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Patients with resistant hypertension and taking 4 BP medications

Severe congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test if patients can better manage their blood pressure with the help of a clinical pharmacist and if this lowers their blood pressure more than the standard care.

Who is the study for?

This trial is for Veterans aged 18 or older with moderate chronic kidney disease (CKD) and uncontrolled high blood pressure. They must not be pregnant, have severe hypertension, liver disease, heart failure, cognitive decline due to dementia, or a life expectancy less than one year.

What is being tested?

The study compares two methods: patients managing their own blood pressure medication under a pharmacist's guidance versus standard care with home monitoring of blood pressure. It aims to see which method better lowers blood pressure in CKD patients.

What are the potential side effects?

Potential side effects may include issues related to incorrect self-management like abnormal blood pressure levels. However, since the intervention involves non-drug measures (self-monitoring and management), significant side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My kidney function is reduced, and I may have protein in my urine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have high blood pressure not controlled by 4 different medications.

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I have severe heart failure.

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I have severe memory loss due to dementia.

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My kidney function is severely reduced.

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I have severe liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in standardized office BP

Secondary study objectives

Change in conventional office BP

Change in standardized office diastolic BP

Home BP readings

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Self-managementExperimental Treatment1 Intervention

Patients monitor their home BP and self manage their BP medications based on a predesigned titration protocol and under the guidance of the clinical pharmacist.

Group II: Self-monitoringActive Control1 Intervention

Patients monitor their home BP and contact their provider if the BP is above the goal.

0 / 7Eligibility criteria met