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New treatment option for Chronic Kidney Diseases
Official title Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
ClinicalTrials.gov ID: NCT04984226
What this study is testing
What is Sodium bicarbonate?
Sodium bicarbonate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic kidney diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 85
You may be able to join if
- Moderate-severe CKD determined by eGFR \<50ml/min per 1.73m2 by CKD EPI equation on at least 2 consecutive occasions.
- Metabolic acidosis defined as bicarbonate level\<24 on two consecutive occasions. Bicarbonate level of 24 or less allowed if eGFR\<=45ml/min per...
- Age 21 to 85 years old
You likely can't join if
- Type 1 diabetes
- Poorly controlled diabetes (HgbA1c\>10%)
- History of persistent hyperkalemia (K\>5.4)
- History of persistent hypokalemia (K\<3.3)
- Uncontrolled blood pressure (\>170/100)
- Chronic treatment with renal replacement therapy
See the full eligibility criteria
- Moderate-severe CKD determined by eGFR \<50ml/min per 1.73m2 by CKD EPI equation on at least 2 consecutive occasions.
- Metabolic acidosis defined as bicarbonate level\<24 on two consecutive occasions. Bicarbonate level of 24 or less allowed if eGFR\<=45ml/min per 1.73m2
- Age 21 to 85 years old
- Type 1 diabetes
- Poorly controlled diabetes (HgbA1c\>10%)
- History of persistent hyperkalemia (K\>5.4)
- History of persistent hypokalemia (K\<3.3)
- Uncontrolled blood pressure (\>170/100)
- Chronic treatment with renal replacement therapy
- History of aortic dissection or severe valvular heart disease
- Exercise induced angina
- Uncontrolled cardiac dysrhythmia
- Oxygen dependent chronic obstructive pulmonary disease (COPD)
- Symptomatic claudication
- End stage liver disease
- Mobility disability defined as inability to walk without human assistance
- Dementia or psychosis
- Patients who cannot consent
- Active use of intraveneous drugs
- Non-english speaking
- History of transplant
- Implants that prohibit MRI measurements or trauma involving metal fragments
- Pacemaker
- Expectation to start dialysis during the course of study.
- Women who are breastfeeding, pregnant, or are wanting to become pregnant
- Any condition which in the judgement of the clinical investigator places the participant at risk from participation in the study. Exclusion criteria for optional muscle biopsy
- Drugs- anticoagulants or antiplatelets:
- Anticoagulants, any 1 (coumadin, rivaroxaban, apixaban, dabigatran, edoxaban)
- Antiplatelets, any 2 (aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticragrelor, ticlopidine, vorapaxar)
- Platelet count \<100,000
- International normalized ratio (INR)\>1.4
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.