Alkali Therapy in Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Official Title
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Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With Chronic Kidney Disease

Conditions
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Chronic Kidney Disease, Metabolic Acidosis

Intervention / Treatment
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* Drug: Sodium bicarbonate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium bicarbonate<br>0.4 mEq/kg/day ideal body weight to be taken once a day | Drug: Sodium bicarbonate<br>* 0.4 mEq/kg/day ideal body weight to be taken once a day<br>|
| Placebo Comparator: Placebo<br>placebo dosage/frequency equivalent to sodium bicarbonate | Drug: Placebo<br>* To be taken on the same schedule as the active arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times | Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups. | 2 year | 
| DEXA of Wrist | The investigators will evaluate changes in bone mineral density at the wrist. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand-grip Strength | Hand-grip strength will be measured in all participants | 2 year | 
| Estimated GFR | Estimated GFR | 2 year | 
| Quality of Life - Physical Function Domain | Short Form- 36 (SF-36) will be performed in all participants. We will evaluate effects on the Physical Function Domain. The Physical Function Domain is scored from 0 to 100 with higher scores meaning better physical functioning. | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alkali, Sodium bicarbonate, Kidney disease, Acidosis