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Alkalinizing Agent

Sodium Bicarbonate for Chronic Kidney Disease (Senergy-CKD Trial)

Phase 2

Recruiting

Led By Baback Roshanravan, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

Moderate-severe CKD determined by eGFR <50ml/min per 1.73m2 by CKD EPI equation on at least 2 consecutive occasions

Age 21 to 85 years old

Must not have

Mobility disability defined as inability to walk without human assistance

Expectation to start dialysis during the course of study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Summary

This trial will study how well treating metabolic acidosis helps improve physical endurance in people with chronic kidney disease.

Who is the study for?

This trial is for adults aged 21-85 with moderate to severe chronic kidney disease (CKD) and metabolic acidosis. Participants must have a confirmed eGFR <50ml/min per 1.73m2 and bicarbonate levels below 24 on two occasions. It's not open to those with end-stage liver disease, uncontrolled diabetes or heart issues, mobility disabilities, dementia, non-English speakers, or certain medical implants.

What is being tested?

The study tests whether sodium bicarbonate can improve muscle mitochondrial metabolism and physical endurance in CKD patients by treating metabolic acidosis. Participants will receive either sodium bicarbonate or a placebo to compare effects on their skeletal muscle health.

What are the potential side effects?

Sodium bicarbonate may cause side effects like stomach pain, nausea, swelling due to fluid retention, high blood pressure from increased sodium intake; however specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function is low, confirmed by tests.

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I am between 21 and 85 years old.

Exclusion Criteria

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

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I cannot walk without someone helping me.

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I expect to start dialysis soon.

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My liver is in its final stage of disease.

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My diabetes is not well-managed (HgbA1c over 10%).

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I am unable to give consent for medical procedures.

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I have had a severe heart valve problem or a tear in my aorta.

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I am on long-term dialysis treatment.

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I experience leg pain when walking.

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I manage my type 2 diabetes with insulin.

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I experience chest pain when I exercise.

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I have an irregular heartbeat that is not under control.

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I do not speak English.

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I need oxygen therapy for my COPD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 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

Fluorine

Insulin sensitivity (SI) by insulin clamp

Walking endurance by 6-minute walk

+3 more

Secondary study objectives

30 second sit to stand test

Intermuscular fat by MRI

PROMIS Fatigue (PRO)

Other study objectives

Inflammatory cytokines. TNF-alpha and IL-6

Muscle mitochondrial respiration from in situ high resolution respirometry of muscle biopsy tissue

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Sodium bicarbonate 16 weeksExperimental Treatment1 Intervention

Sodium bicarbonate will be dosed at 0.8meq per kilogram of ideal body weight daily (1meq is approximately 84mg). We will use the Devine formula to determine ideal body weight. Investigational Drug Services at both UC Davis and Vanderbilt will compound the sodium bicarbonate. Sodium bicarbonate 650 mg tablets will be over-encapsulated and matching placebo capsules will be prepared. Participants will be limited to a maximum of 9 capsules daily (maximum dose = 5850mg of sodium bicarbonate). Capsules will be dispensed to patients in two separate 8-week allotments. The dose will be rounded to the nearest whole capsule and depending on participant preference may be divided into portions taken twice or thrice daily. Given the high probability of interruption in sodium bicarbonate supply and availability, we may need to change brands of sodium bicarbonate intermittently.

Group II: placebo 16 weeksPlacebo Group1 Intervention

Microcrystalline cellulose

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sodium bicarbonate

2012

Completed Phase 4

~3680

0 / 15Eligibility criteria met