Alkali Therapy in Chronic Kidney Disease

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease, Metabolic Acidosis

In brief

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.

Key facts

Study ID

NCT01452412

Run by

Albert Einstein College of Medicine

People needed

149

Starts

2011-10-01

Expected to finish

2016-08-01

Last updated by the study team

2020-01-07

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Albert Einstein College of Medicine — The Bronx, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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