Phase 3 N=149 Randomized Quadruple-blind Treatment

Alkali Therapy in Chronic Kidney Disease

Chronic Kidney Disease · Metabolic Acidosis

Bottom Line

View on ClinicalTrials.gov: NCT01452412 ↗

Enrolled (actual)

149

Serious AEs

23.5%

Results posted

Jan 2020

Primary outcome: Primary: Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times — 23.8; 22.9 seconds

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Sodium bicarbonate (Drug); Placebo (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Albert Einstein College of Medicine
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times	23.8; 22.9	—
PRIMARY DEXA of Wrist	0.75; 0.73	—
SECONDARY Hand-grip Strength	27.3; 24.9	—
SECONDARY Estimated GFR	38.5; 36.3	—
SECONDARY Quality of Life - Physical Function Domain	40; 43	—

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.

Eligibility Criteria

Inclusion Criteria

Estimate GFR 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01452412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.