Alkali Therapy in Chronic Kidney Disease

Albert Einstein College of Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Kidney Disease; Metabolic Acidosis

Treatments: Drug: Placebo; Drug: Sodium bicarbonate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01452412

R01DK087783 (U.S. NIH Grant/Contract)

2009-408

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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149 participants in 2 patient groups, including a placebo group

Sodium bicarbonate

Experimental group

Description:

0.4 mEq/kg/day ideal body weight to be taken once a day

Treatment:

Drug: Sodium bicarbonate

Placebo

Placebo Comparator group

Description:

placebo dosage/frequency equivalent to sodium bicarbonate

Treatment:

Drug: Placebo