Sodium Bicarbonate for Chronic Kidney Disease
(Senergy-CKD Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byJorge Gamboa, MD PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of California, Davis
Must not be taking: Insulin
Disqualifiers: Diabetes, Hyperkalemia, Heart disease, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Skeletal muscle metabolic health is critical for mobility and an underrecognized target of metabolic acidosis in chronic kidney disease. Impaired muscle mitochondrial metabolism underlies poor physical endurance increasing the risk of mobility disability. The proposed project will use precise in vivo tools to study the pathophysiology of poor physical endurance in a clinical trial treating metabolic acidosis among persons living with chronic kidney disease.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have type 2 diabetes managed with insulin, you cannot participate in the trial.
What data supports the effectiveness of the drug Sodium Bicarbonate for Chronic Kidney Disease?
Sodium bicarbonate is commonly used to treat metabolic acidosis (a condition where the body produces too much acid or the kidneys are not removing enough acid) in chronic kidney disease. It is considered a mainstay treatment for this condition, although concerns exist about administering sodium to patients with high blood pressure or sodium retention issues.
12345Is sodium bicarbonate safe for use in humans?
The research articles provided do not contain specific safety data on sodium bicarbonate for chronic kidney disease or other conditions.
678910How is the drug sodium bicarbonate unique in treating chronic kidney disease?
Sodium bicarbonate is unique in treating chronic kidney disease because it helps correct metabolic acidosis (a condition where the body produces too much acid or the kidneys do not remove enough acid) by increasing bicarbonate levels in the blood. It is often administered orally in a form that resists stomach acid, which helps prevent early release and potential side effects.
15111213Eligibility Criteria
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.Inclusion Criteria
My kidney function is low, confirmed by tests.
Your blood has low levels of bicarbonate on two separate tests.
I am between 21 and 85 years old.
Exclusion Criteria
You have had an organ transplant in the past.
You have a history of high potassium levels (K>5.4).
I cannot walk without someone helping me.
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive sodium bicarbonate or placebo for 16 weeks to assess muscle metabolic health and physical endurance
16 weeks
Visits every 8 weeks for capsule dispensing
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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.
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
Sodium Bicarbonate is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Sodium Bicarbonate for:
- Metabolic acidosis
- Heartburn
- Acid indigestion
- Upset stomach
- Severe renal disease
- Circulatory insufficiency due to shock
🇪🇺 Approved in European Union as Sodium Bicarbonate for:
- Metabolic acidosis
- Heartburn
- Acid indigestion
- Upset stomach
- Severe renal disease
- Circulatory insufficiency due to shock
🇨🇦 Approved in Canada as Sodium Bicarbonate for:
- Metabolic acidosis
- Heartburn
- Acid indigestion
- Upset stomach
- Severe renal disease
- Circulatory insufficiency due to shock
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
University of California Davis HealthSacramento, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
Vanderbilt University Medical CenterCollaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Enteric-coated solid dosage forms containing sodium bicarbonate as a drug substance: an exception from the rule? [2014]Sodium bicarbonate (sodium hydrogen carbonate) is used as an oral medication in disorders such as mild metabolic acidosis and chronic kidney disease. The two commercial products on the German market, bicaNorm and Nephrotrans, and also newly developed multiple-unit pellet formulations, have been characterized in these investigations by in-vitro methods like disintegration and dissolution testing. Both marketed products containing sodium bicarbonate are of sufficient pharmaceutical quality according to the European Pharmacopoeia. However, they and the novel pellet preparations showed different drug release at moderately elevated pH values. Early drug release may cause dose dumping in the stomach and adverse drug effects from the developed carbon dioxide. The soft capsule preparation (Nephrotrans) released the smallest amount of sodium bicarbonate at pH 1 and 4.5 of all formulations tested. It appeared that oral dosage formulations of sodium bicarbonate were an exception to the rule: the monolithic soft capsule seemed to be superior to an enteric-coated tablet as well as to multiple-unit pellet formulations from the biopharmaceutical point of view. Our results correspond with individual reports on adverse effects from patients treated with the sodium bicarbonate products.
Sevelamer worsens metabolic acidosis in hemodialysis patients. [2015]Sevelamer hydrochloride, a major phosphate binder for patients on maintenance hemodialysis (MHD) is associated with reduced serum bicarbonate concentration due to hydrochloric acid release in the gut and to the binding of short chain fatty acids in the large intestine. Since metabolic acidosis can be deleterious, a study was devised to compare the time course of serum bicarbonate concentration during treatment with sevelamer hydrochloride or calcium carbonate.
Sevelamer hydrochloride dose-dependent increase in prevalence of severe acidosis in hemodialysis patients: analysis of nationwide statistical survey in Japan. [2015]Metabolic acidosis has a negative impact on prognosis of dialysis patients. The aim of this study was to determine the prevalence of severe metabolic acidosis in dialysis patients treated with sevelamer hydrochloride. In 2004, a nationwide survey (101,516 dialysis patients) was conducted by the Japanese Society for Dialysis Therapy. We analyzed 32,686 dialysis patients whose bicarbonate levels were measured in the survey. Sevelamer hydrochloride was prescribed to 9231 dialysis patients while 23,455 dialysis patients were not prescribed sevelamer hydrochloride. In the present study, we defined severe acidosis as bicarbonate
Veverimer: An Emerging Potential Treatment Option for Managing the Metabolic Acidosis of CKD. [2020]Sodium bicarbonate is the mainstay treatment of the metabolic acidosis of chronic kidney disease but associated concerns center on administering sodium to patients with hypertension and sodium-retentive states. Veverimer (formerly referred to as TRC101), a drug candidate for which Tricida, Inc is seeking approval from the US Food and Drug Administration, is a novel nonabsorbable polymer that binds hydrogen cations and chloride anions in the gastrointestinal tract and then is excreted fecally, thereby increasing serum bicarbonate concentration without administering sodium. We examine the published evidence on the investigational use of veverimer in patients with chronic kidney disease and metabolic acidosis. We highlight the achieved increase in serum bicarbonate concentration without coadministering sodium, effects on physical functioning, and the safety record of the drug. We also scrutinize certain unanticipated findings: a lack of dose dependency in the increase in serum bicarbonate concentration observed and that despite the presumed large hydrogen chloride losses in feces, veverimer induces an isochloremic increase in serum bicarbonate concentration that is accompanied by a decrease in serum anion gap. We propose likely explanations for these puzzling findings and raise questions about veverimer's mode of action and its potential interaction with colonic bacterial flora. Additional work is required to fill these knowledge gaps that could have important clinical implications.
A prospective, multicenter, randomized, controlled study: the correction of metabolic acidosis with use of bicarbonate in Chronic Renal Insufficiency (UBI) Study. [2013]A Cochrane Collaboration review (Roderick, Cochrane Data base of systemic reviews 2007, DOI 10.1002/14651858.CD0018.90.pub3) reported that there was no evidence for correction of acidosis by sodium bicarbonate in pre-end-stage renal disease (ESRD) patients, and concluded that randomized controlled trials (RCTs) are necessary to evaluate the benefits and harms of correcting metabolic acidosis in pre-ESRD patients. We wanted to evaluate if the administration of alcaly (mainly sodium bicarbonate) is able to significantly modify renal death and to reduce mortality due to cardiovascular events.
Bowel preparation in CT colonography: electrolyte and renal function disturbances in the frail and elderly patient. [2021]Elderly patients are at increased risk of biochemical disturbances secondary to cathartic medications. This study investigates the renal function, electrolyte and clinical disturbances associated with CT colonography (CTC) with sodium picosulphate-magnesium citrate (SPS-MC) in a subgroup of frail, elderly patients.
Colonoscopy preparation: polyethylene glycol with Gatorade is as safe and efficacious as four liters of polyethylene glycol with balanced electrolytes. [2021]Four liters of polyethylene glycol 3350 (PEG) with balanced electrolytes for colonoscopy preparation has had poor acceptance. Another approach is the use of electrolyte-free PEG combined with 1.9 L of Gatorade. Despite its widespread use, there are no data on metabolic safety and minimal data on efficacy. Our aim was to assess the efficacy and electrolyte safety of these two PEG-based preparations.
Split-dose 1 L polyethylene glycol (PEG) with ascorbate is non-inferior to split-dose PEG with sodium picosulfate and magnesium citrate with similar tolerability: a randomized study. [2022]Post-marketing studies comparing low-volume polyethylene glycol (PEG)-based regimens are limited. This randomized study aimed to compare the efficacy and tolerability of a novel 1-L low-volume PEG-based preparation: 1 L PEG+Asc (PEG3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride) with PEG+SPMC (PEG3350, sodium chloride, potassium chloride and sodium sulfate, sodium picosulfate, magnesium oxide, citric acid, and aspartame), prior to routine colonoscopy at an Australian tertiary referral center.
[Phosphate nephropathy: how to avoid it?]. [2013]Colonoscopy is a commonly used procedure for colon cancer screening. The ideal bowel preparation for a good visualization of the colonic mucosa would be effective and well tolerated. Sodium phosphate (NaP) and polyethylen glycol (PEG) are the two most frequently used solutions in this indication. However, although NaP has been described as more effective and better tolerated, it can cause severe acute electrolytes disturbances and, in rare cases, lead to irreversible renal failure, called phosphate nephropathy. NaP should therefore be prescribed with caution and be formally banned for patients with risk factors.
Palatability of colonic lavage solution is improved by the addition of artificially sweetened flavored drink mixes. [2019]A frequent complaint of patients asked to drink polyethylene glycol (PEG) colonic lavage solution is the salty flavor. This often results in failure to ingest the entire 4 liters of the solution and compromises bowel cleansing. The purpose of this study was to determine systematically whether the addition of a flavored drink mix sweetened with aspartame to the PEG lavage solution would improve palatability without significantly altering the osmolality of the solution. Eighty-seven (87) staff volunteers participated in a taste test of PEG lavage solutions containing varying amounts of commercially available drink mixes. The solution containing two packages of lemon-flavored KoolAid drink mix sweetened with aspartame was significantly more palatable than the others (p less than 0.005), while osmolality remained within the range specified by the manufacturer of Colyte.
The Prevalence and Management of Metabolic Acidosis of Chronic Kidney Disease [2020]Aim Emerging evidence supports initiating oral sodium bicarbonate (OSB) at a serum bicarbonate (HCO3) level of less than 22mmol/L. We look to identify the prevalence of metabolic acidosis of chronic kidney disease (MA-CKD) and its management with OSB at a regional university hospital. Methods Retrospective data was collected using the national electronic renal database (eMED) to identify chronic kidney disease (CKD) patients with MA-CKD over a one-year period. Results One-hundred and forty-four patients were identified with CKD, of which 131 (89%) were tested for HCO3. MA-CKD was present in 44 patients (34%), all had eGFR
[Effects of improved levels of plasma bicarbonates in terminal renal failure]. [2013]Correction of chronic renal acidosis was attempted for 6 weeks in 20 end stage renal failure patients on chronic acetate hemodialysis by means of 6-9 g of sodium bicarbonate given orally by means of gastric juice resistant capsule of 1 g. Normalisation of the inter-dialysis acid base status was obtained without major side effects.
Sodium bicarbonate to improve physical function in patients over 60 years with advanced chronic kidney disease: the BiCARB RCT. [2021]Advanced chronic kidney disease is common in older people and is frequently accompanied by metabolic acidosis. Oral sodium bicarbonate is used to treat this acidosis, but evidence is lacking on whether or not this provides a net gain in health or quality of life for older people.