What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) include progressive resistance training (PRT) and glucocorticoids. PRT has been shown to induce skeletal muscle hypertrophy, increase muscular strength, and improve health-related quality of life, but it may also lead to muscle soreness and fatigue. Glucocorticoids, used to reduce inflammation and slow disease progression, can cause serious adverse events such as severe infections, hyperkalemia, and increased risk of cardiovascular events. Additionally, patients may experience weight gain, osteoporosis, and mood changes. It is important to monitor these side effects closely and adjust treatment as necessary.

What prior FDA approvals exist?

FDA-approved treatments for Chronic Kidney Disease (CKD) primarily focus on managing symptoms and slowing disease progression. These include medications like angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) to control blood pressure and reduce proteinuria. Sodium-glucose co-transporter 2 (SGLT2) inhibitors, such as dapagliflozin, have also been approved for CKD treatment due to their cardiovascular and renal protective effects. While specific FDA approvals for exercise therapy in CKD are not mentioned, the benefits of exercise in improving cardiovascular and muscular function are well-documented and often recommended as part of a comprehensive CKD management plan.

What other types of research exist?

Promising novel alternatives to exercise therapy for CKD patients include: 1) Myostatin inhibitors, which aim to increase muscle bulk and strength, though clinical benefits are yet to be confirmed. 2) Cell therapy using allogeneic cardiosphere-derived cells (CDCs), which have shown potential in reducing disease progression through anti-inflammatory effects. 3) Investigational pharmacologic agents targeting mitochondrial function and muscle fatigue, though further research is needed to confirm efficacy.

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Behavioral Intervention

Exercise for Chronic Kidney Disease

Phase 2

Recruiting

Led By Jeanie Park, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Patients with CKD or persons without kidney disease as matched study controls

CKD patients must have stable renal function (no greater than a decline of estimated glomerular filtration (eGFR) of 1 cc/min/1.73 m2 per month over the prior 6 months) and baseline serum bicarbonate 22-24 mmol/L

Must not have

Class 3 obesity (BMI>40)

Current use of immunosuppressive medications (including but not limited to steroids, cyclophosphamide, calcineurin inhibitors, mycophenolate, biologics, methotrexate, etc)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 12

Summary

This trial aims to help people with chronic kidney disease improve their ability to exercise. It uses regular physical activity and a substance similar to baking soda to make it easier for their muscles to get enough blood during exercise.

Who is the study for?

This trial is for sedentary adults with stable chronic kidney disease (CKD) or healthy individuals as controls. CKD participants should have a steady kidney function, normal serum bicarbonate levels, and may have hypertension. Excluded are those with severe obesity, uncontrolled high blood pressure, recent surgery, pregnancy plans, certain heart conditions or metal implants that affect MRI scanning.

What is being tested?

The study explores how exercise affects people with CKD compared to healthy controls. It tests whether exercise training or sodium bicarbonate supplementation can improve the body's response to physical activity in CKD patients versus a placebo group.

What are the potential side effects?

Potential side effects from the interventions could include muscle soreness or fatigue from exercise training and digestive discomfort from sodium bicarbonate supplementation.

Eligibility Criteria

Inclusion Criteria

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

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I either have chronic kidney disease or I do not have any kidney disease.

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My kidney function is stable and my blood's bicarbonate level is within the normal range.

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I have high blood pressure.

Exclusion Criteria

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

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My BMI is over 40.

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I am currently taking medications that suppress my immune system.

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My heart pumps less blood than normal.

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I have nerve damage due to diabetes.

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I am currently taking bicarbonate.

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I have symptoms of heart failure.

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I cannot stop taking my α- and β-blocker medications.

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My blood pressure is not higher than 170/100 mm Hg.

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My kidney function is severely reduced.

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I have peripheral arterial disease.

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I have heart problems that show up on tests or in my medical history.

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I am currently taking medication like clonidine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 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 Exercise Capacity

Secondary study objectives

Change in Diastolic Blood Pressure

Change in Exercise Pressor Reflex

Change in Interleukin 6 (IL-6)

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Exercise Training plus Sodium BicarbonateExperimental Treatment2 Interventions

Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take 650-1300 mg of sodium bicarbonate twice daily.

Group II: Exercise Training plus PlaceboActive Control2 Interventions

Participants with CKD will undergo exercise training for 20-45 minutes, 3 times per week, for 12 weeks. Additionally, participants take placebo tablets to match 650-1300 mg of sodium bicarbonate twice daily.

Group III: Healthy controlActive Control1 Intervention

Baseline measurements in healthy participants without CKD will be measured and compared to participants with CKD. Healthy controls will not receive any interventions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Training

2011

Completed Phase 3

~1470

Sodium Bicarbonate

2015

Completed Phase 4

~2060

0 / 15Eligibility 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

Exercise therapy for Chronic Kidney Disease (CKD) patients works by enhancing cardiovascular and muscular function. It improves blood flow, reduces blood pressure, and increases muscle strength and endurance. These benefits are crucial for CKD patients, who often face reduced exercise capacity, cardiovascular issues, and muscle wasting. By addressing these problems, exercise therapy can help slow disease progression and improve the quality of life for CKD patients.

Uremic Sarcopenia: Clinical Evidence and Basic Experimental Approach.