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Purpose

Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones, glucose metabolism and kidney.

Conditions

Eligibility

Eligible Ages
Over 19 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Estimate GFR <= 45 and >15 ml/min/1.73m2 - Age >18

Exclusion Criteria

  • Previous chronic treatment with alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda) - 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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sodium bicarbonate 		0.4 mEq/kg/day ideal body weight to be taken once a day
  • Drug: Sodium bicarbonate
    0.4 mEq/kg/day ideal body weight to be taken once a day
Placebo Comparator
Placebo 		placebo dosage/frequency equivalent to sodium bicarbonate
  • Drug: Placebo
    To be taken on the same schedule as the active arm

More Details

Status
Completed
Sponsor
Albert Einstein College of Medicine

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.