Alkali Therapy in Chronic Kidney Disease

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)

Criteria

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