What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD), such as diuretics, can have several side effects. These include electrolyte imbalances (e.g., low potassium or sodium levels), dehydration, increased uric acid levels which may lead to gout, and potential deterioration of kidney function. Loop diuretics, specifically, can cause ototoxicity at high doses. When used with other medications like ACE inhibitors or angiotensin receptor blockers, there is an increased risk of hyperkalemia.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Kidney Disease (CKD) that focus on managing volume overload, a common complication in CKD patients. Diuretics, such as loop diuretics, are commonly used to increase urine production and remove excess fluid, thereby reducing volume overload. These medications help alleviate symptoms like edema and hypertension, which are prevalent in CKD. Additionally, other antihypertensive agents, including ACE inhibitors and angiotensin receptor blockers, are often used in conjunction with diuretics to manage blood pressure and reduce the progression of kidney disease.

What other types of research exist?

Promising novel alternatives to diuretics for treating volume overload in Chronic Kidney Disease patients include adenosine receptor antagonists, endothelin receptor antagonists, vasopressin receptor antagonists, and extracorporeal ultrafiltration. These therapies are being explored for their potential to improve renal function and manage fluid balance effectively.

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Diuretic

Diuretics for Early Chronic Kidney Disease (DOCK Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Chronic Kidney Disease (CKD) include diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs), and calcium channel blockers. Diuretics increase urine production to remove excess fluid, reducing volume overload and the risk of cardiovascular complications. ACE inhibitors and ARBs relax blood vessels and lower blood pressure, decreasing the workload on the kidneys and slowing disease progression. Calcium channel blockers also lower blood pressure by relaxing blood vessels. These treatments are essential for managing symptoms, preventing complications, and slowing the progression of CKD.

Phase 4

Recruiting

Led By Lucile P Gregg, 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

Be older than 18 years old

Must not have

Unable to understand or provide informed consent.

CKD stages 4-5, defined as eGFR <30 mL/min/1.73 m2.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether medications that help remove extra fluid from the body can improve heart health in Veterans with early-stage kidney disease and high blood pressure. By reducing fluid volume, these medications may lower blood pressure and decrease heart strain. These medications have been used to manage extra fluid buildup and control blood pressure in various conditions, including heart failure and high blood pressure, for many years.

Who is the study for?

This trial is for Veterans with early-stage chronic kidney disease (CKD stages 1-3) who have high blood pressure. Participants must be at least 18 years old, able to give informed consent, and not on dialysis or a recipient of a kidney transplant. Those with severe heart issues, liver cirrhosis, major limb amputation, pregnancy, or certain devices like pacemakers are excluded.

What is being tested?

The study tests whether diuretics (like hydrochlorothiazide or furosemide) can reduce fluid overload in the body and improve cardiovascular health in people with early CKD. It compares two methods of measuring fluid overload and observes changes in symptoms and short-term heart function after treatment.

What are the potential side effects?

Diuretics may cause dehydration, electrolyte imbalances (like low potassium), dizziness upon standing up due to lowered blood pressure, increased urination frequency, fatigue, muscle cramps or weakness.

Eligibility Criteria

Exclusion Criteria

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

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I am able to understand and give informed consent.

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My kidney function is very low (stage 4-5 CKD).

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I have been diagnosed with liver cirrhosis.

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I am willing and able to follow the study's requirements.

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I have received a kidney transplant.

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I am on long-term dialysis treatment.

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I have had a major limb amputation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks 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 NT-pro-BNP

Secondary study objectives

Change in BNP

Change in FACIT-F score

Change in KDQOL

+8 more

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.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diuretic augmentationExperimental Treatment1 Intervention

The participant's blood pressure medication regimen will be altered to initiate a thiazide-type or loop diuretic in those not already prescribed a diuretic, or to increase the dose if one is already prescribed.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Kidney Disease (CKD) include diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs), and calcium channel blockers. Diuretics increase urine production to remove excess fluid, reducing volume overload and the risk of cardiovascular complications. ACE inhibitors and ARBs relax blood vessels and lower blood pressure, decreasing the workload on the kidneys and slowing disease progression. Calcium channel blockers also lower blood pressure by relaxing blood vessels. These treatments are essential for managing symptoms, preventing complications, and slowing the progression of CKD.

Kidney and aetiology, pathology and management of essential hypertension.Effectiveness, nephrotoxicity, and therapeutic drug monitoring of polymyxin B in nosocomial pneumonia among critically ill patients.Caloric restriction, physical exercise, and CB1 receptor blockade as an efficient combined strategy for bodyweight control and cardiometabolic status improvement in male rats.