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Completed
NCT06545461
Treating Metabolic Acidosis in Chronic Kidney Disease to Prevent Adverse Kidney and Cardiovascular Outcomes
Conditions: Chronic Kidney Diseases, Cardiovascular Diseases, Hypertension
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 108
Sponsor: Donald Wesson
Summary
Upon completion, this project will determine if treatment of metabolic acidosis in non-diabetic study participants with reduced kidney function (chronic kidney disease \[CKD\] stage 3) associated with high blood pressure (hypertension) and macroalbuminuria, the latter indicating pronounced kidney injury, using either base-producing fruits and vegetables (F+V) or standard therapy for treatment of metabolic acidosis with the medication sodium bicarbonate (NaHCO3) 1) slows progression of CKD toward end-stage renal disease \[ESRD\]; 2) improves indices of cardiovascular disease (CVD) risk; and 3) better preserves plasma acid-base parameters. These studies are designed to compare the differential effects of treating the metabolic acidosis of CKD with F+Vs or NaHCO3 on kidney outcomes, including progression to ESRD, on indices of CVD risk and on plasma acid-base parameters.
Eligibility Criteria
Inclusion Criteria:
1. Non-malignant high blood pressure or hypertension
2. 18-70 yrs old
3. urine albumin-to-creatine ratio \> 200 mg/g creatinine
4. estimated glomerular filtration rate (eGFR) 30 to 59 ml/min/1.73 m2
5. Plasma total CO2 (PTCO2) \> 22 but \< 24 mmol/l
6. able to tolerate angiotensin converting enzyme \[ACE\] inhibition drug therapy because guidelines recommend it for patients with albuminuric CKD
7. non-smoking
8. greater than or equal to 2 primary care visits in the preceding year, indicating compliance
9. Able to provide informed consent.
Exclusion Criteria:
1. Malignant hypertension or history thereof
2. primary kidney disease or findings consistent thereof such as \> 3 red blood cells per high powered field of urine or urine cellular casts
3. history of diabetes or fasting glucose greater than or equal to 110/mg/dl
4. history of hematologic disorders, malignancies, chronic infections, current pregnancy, history or clinical evidence of CVD
5. peripheral edema or diagnosis associated with edema such as heart/liver failure or nephrotic syndrome because of the sodium load that accompanies NaHCO3 therapy
6. baseline plasma potassium concentration \> 4.6 mmol/l to reduce the risk for hyperkalemia in those participants randomized to F+Vs which increases dietary potassium intake
7. taking, or unable to stop taking, drugs other than ACE inhibitors that limit urine potassium excretion
8. Unable to provide informed consent.
Source: ClinicalTrials.gov (NCT06545461). StuddyBuddy aggregates publicly available trial information.