Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
149 participants
INTERVENTIONAL
2011-10-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sodium bicarbonate
0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate
0.4 mEq/kg/day ideal body weight to be taken once a day
Placebo
placebo dosage/frequency equivalent to sodium bicarbonate
Placebo
To be taken on the same schedule as the active arm
Interventions
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Sodium bicarbonate
0.4 mEq/kg/day ideal body weight to be taken once a day
Placebo
To be taken on the same schedule as the active arm
Eligibility Criteria
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Inclusion Criteria
* Age \>18
Exclusion Criteria
* bicarbonate level \<20 or \>25 mEq/L
* New York Heart Association Class III or IV heart failure
* Systolic blood pressure \>180 mmHg
* Initiation of ESRD treatment planned within 6 months
* Kidney transplantation
* Treatment with immunosuppressives within the last 3 months
19 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
National Institutes of Health (NIH)
NIH
Albert Einstein College of Medicine
OTHER
Responsible Party
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Michal L. Melamed
Associate Professor
Principal Investigators
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Thomas Hostetter, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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Albert Einstein College of Medicine
The Bronx, New York, United States
Case Western Reserve University
Cleveland, Ohio, United States
Countries
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References
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Brightwell CR, Kulkarni AS, Paredes W, Zhang K, Perkins JB, Gatlin KJ, Custodio M, Farooq H, Zaidi B, Pai R, Buttar RS, Tang Y, Melamed ML, Hostetter TH, Pessin JE, Hawkins M, Fry CS, Abramowitz MK. Muscle fibrosis and maladaptation occur progressively in CKD and are rescued by dialysis. JCI Insight. 2021 Dec 22;6(24):e150112. doi: 10.1172/jci.insight.150112.
Melamed ML, Horwitz EJ, Dobre MA, Abramowitz MK, Zhang L, Lo Y, Mitch WE, Hostetter TH. Effects of Sodium Bicarbonate in CKD Stages 3 and 4: A Randomized, Placebo-Controlled, Multicenter Clinical Trial. Am J Kidney Dis. 2020 Feb;75(2):225-234. doi: 10.1053/j.ajkd.2019.07.016. Epub 2019 Nov 5.
Other Identifiers
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2009-408
Identifier Type: -
Identifier Source: org_study_id
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