Phase 3
Completed N=149
Alkali Therapy in Chronic Kidney Disease
Chronic Kidney Disease · Metabolic Acidosis
Source: ClinicalTrials.gov NCT01452412 ↗
Enrolled (actual)
149
Serious AEs
23.5%
Results posted
Jan 2020
Primary outcomePrimary: Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times — 23.8; 22.9 seconds
◆ Published Evidence
Established
95citations · ~16 / year
Effects of Sodium Bicarbonate in CKD Stages 3 and 4: A Randomized, Placebo-Controlled, Multicenter Clinical Trial.
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.
Linked Publications (2)
-
Effects of Sodium Bicarbonate in CKD Stages 3 and 4: A Randomized, Placebo-Controlled, Multicenter Clinical Trial.
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Muscle fibrosis and maladaptation occur progressively in CKD and are rescued by dialysis.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT01452412) and the linked publication. 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. Informational only — not medical advice.