Alkali Therapy in Chronic Kidney Disease

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

  • Chronic Kidney Disease
  • Metabolic Acidosis

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