CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 149 enrolled
Drug / intervention
Sodium bicarbonate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01452412
NCT01452412Phase 3Completed
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Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With Chronic Kidney Disease

Albert Einstein College of Medicine·interventional·Posted Oct 14, 2011·Updated Jan 7, 2020

In Brief

A Phase 3 clinical trial evaluating Sodium bicarbonate and Placebo for Chronic Kidney Disease and Metabolic Acidosis. Completed, enrolled 149 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Metabolic Acidosis
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 14, 2011
Enrollment StartOct 1, 2011
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.7 years ago

Interventions

Sodium bicarbonatedrug

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

Placebodrug

To be taken on the same schedule as the active arm