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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Senergy-CKD Trial 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.Check my eligibility
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.See study design
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.

Senergy-CKD 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.

Senergy-CKD Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fluorine
Insulin sensitivity (SI) by insulin clamp
Walking endurance by 6-minute walk
+3 more
Secondary outcome measures
30 second sit to stand test
Intermuscular fat by MRI
PROMIS Fatigue (PRO)
Other outcome measures
Inflammatory cytokines. TNF-alpha and IL-6
Muscle mitochondrial respiration from in situ high resolution respirometry of muscle biopsy tissue

Senergy-CKD 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

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,503 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
856 Previous Clinical Trials
672,112 Total Patients Enrolled
1 Trials studying Metabolic Acidosis
2,093 Patients Enrolled for Metabolic Acidosis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,161 Total Patients Enrolled
2 Trials studying Metabolic Acidosis
269 Patients Enrolled for Metabolic Acidosis

Media Library

Sodium Bicarbonate (Alkalinizing Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04984226 — Phase 2
Metabolic Acidosis Research Study Groups: placebo 16 weeks, Sodium bicarbonate 16 weeks
Metabolic Acidosis Clinical Trial 2023: Sodium Bicarbonate Highlights & Side Effects. Trial Name: NCT04984226 — Phase 2
Sodium Bicarbonate (Alkalinizing Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04984226 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions is Veverimer commonly used to treat?

"Veverimer has shown to be effective in the treatment of barbiturates, helicobacter infections, and severe diarrhea."

Answered by AI

If a person is under 55 years old, can they participate in this trial?

"Patients that meet the age requirements of 30 to 85 years old are eligible for this clinical trial. There are 105 other trials available for patients under 18 and 916 trials accessible for senior citizens."

Answered by AI

Are there any open slots in this research project for participants?

"This study is not looking for participants at the moment. The earliest posting was on July 15th, 2022 and the most recent edit was on May 10th, 2022. For those who are still interested in clinical trials, there are 1091 active studies involving patients with insulin resistance and 21 more testing Veverimer."

Answered by AI

How many people are enrolled in this experiment?

"Although this trial is no longer recruiting patients, Veverimer clinical trials are still ongoing with 21 studies presently seeking participants. If you require more information, 1091 other clinical trials for insulin resistance are actively admitting patients."

Answered by AI

Has Veverimer received government sanctioning for use?

"Veverimer safety is currently unproven but there is some evidence to support its use. Our team at Power estimates that, on a scale from 1-3, Veverimer rates a 2."

Answered by AI

Are there any other instances where Veverimer has been used in research?

"Currently, there are 21 ongoing research studies utilising Veverimer. 1 of these studies is in Phase 3 clinical trials. Although the majority of research for Veverimer takes place in Decatur, Georgia; 30 different locations across the country are running tests with this medication."

Answered by AI

Does this trial have any specific inclusion criteria for participants?

"Currently, this study is looking for 102 individuals that suffer from insulin resistance and meet the following conditions: They must be between 30 and 85 years old, have moderate-severe CKD as determined by eGFR <60ml/min per 1.73m2 on at least 2 occasions, and have metabolic acidosis defined as a bicarbonate level<23 on two separate occassions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
Baback Roshanravan 2023. "Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04984226.
~53 spots leftby Dec 2025
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