Status:
COMPLETED
Treating Metabolic Acidosis in Chronic Kidney Disease to Prevent Adverse Kidney and Cardiovascular Outcomes
Lead Sponsor:
University of Texas at Austin
Conditions:
Chronic Kidney Diseases
Cardiovascular Diseases
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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...
Detailed Description
The long-term objective of this study is to determine if treatment of metabolic acidosis in study participants with chronic kidney disease (CKD), reduced estimated glomerular filtration rate (eGFR), a...
Eligibility Criteria
Inclusion
- Non-malignant high blood pressure or hypertension
- 18-70 yrs old
- urine albumin-to-creatine ratio \> 200 mg/g creatinine
- estimated glomerular filtration rate (eGFR) 30 to 59 ml/min/1.73 m2
- Plasma total CO2 (PTCO2) \> 22 but \< 24 mmol/l
- able to tolerate angiotensin converting enzyme \[ACE\] inhibition drug therapy because guidelines recommend it for patients with albuminuric CKD
- non-smoking
- greater than or equal to 2 primary care visits in the preceding year, indicating compliance
- Able to provide informed consent.
Exclusion
- Malignant hypertension or history thereof
- primary kidney disease or findings consistent thereof such as \> 3 red blood cells per high powered field of urine or urine cellular casts
- history of diabetes or fasting glucose greater than or equal to 110/mg/dl
- history of hematologic disorders, malignancies, chronic infections, current pregnancy, history or clinical evidence of CVD
- peripheral edema or diagnosis associated with edema such as heart/liver failure or nephrotic syndrome because of the sodium load that accompanies NaHCO3 therapy
- 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
- taking, or unable to stop taking, drugs other than ACE inhibitors that limit urine potassium excretion
- Unable to provide informed consent.
Key Trial Info
Start Date :
June 22 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2016
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06545461
Start Date
June 22 1998
End Date
October 30 2016
Last Update
August 9 2024
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