Chronic Kidney Disease
Conditions
Keywords
metabolic acidosis, chronic kidney disease, Estimated GFR 15-45
Brief summary
This study will enroll 25 patients with kidney disease to evaluate the effects of different doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney function and muscle strength. The investigators will also evaluate safety and tolerability of different doses.
Detailed description
This study enrolled 20 patient to evaluate the effects of different doses of sodium bicarbonate. We will test serum bicarbonate levels, potassium levels and muscle function.
Interventions
DRUGSodium bicarbonate
Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight
DRUGPlacebos
Placebo at 3 different doses to match Sodium bicarbonate dosing
Sponsors
Albert Einstein College of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Estimated GFR \< 45 ml/min/1.73m2 and \>15 ml/min/1.73 m2 determined by abbreviated 4 variable modification MDRD equation * Age \>21
Exclusion criteria
* Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda) * Bicarbonate level \<20 or \>25 mEq/L * Decompensated heart failure * Systolic blood pressure \>160 mm/Hg * Moderate or greater lower extremity edema * Initiation of ESRD treatment planned within 6 months * Kidney transplantation * Treatment with immunosuppressives within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Bicarbonate Levels | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength as Measured by sit-to Stand Test | 8 weeks | 10 repetition sit-to-stand test |
| Systolic Blood Pressure | 8 weeks | — |
Countries
United States
Participant flow
Recruitment details
Patients will receive both active treatment and placebo. Therefore the 20 patients who started placebo also started active treatment. There are only 20 participants total in the study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants went through sequential dosing of placebo, then sodium bicarbonate escalating doses. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 10.8 |
| Diastolic Blood Pressure | 70 mm Hg STANDARD_DEVIATION 7 |
| Race/Ethnicity, Customized Race/ethnicity Black | 11 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic | 9 Participants |
| Serum Bicarbonate Levels | 23.0 mEq/L STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
| Systolic Blood Pressure | 134 mm Hg STANDARD_DEVIATION 13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 2 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Serum Bicarbonate Levels
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Bicarbonate | Serum Bicarbonate Levels | 25.5 mEq/L | Standard Deviation 2.3 |
| Placebos | Serum Bicarbonate Levels | 22.2 mEq/L | Standard Deviation 2.8 |
Secondary
Muscle Strength as Measured by sit-to Stand Test
10 repetition sit-to-stand test
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Bicarbonate | Muscle Strength as Measured by sit-to Stand Test | 22.2 Seconds | Standard Deviation 1.6 |
| Placebos | Muscle Strength as Measured by sit-to Stand Test | 23.8 Seconds | Standard Deviation 1.4 |
Secondary
Systolic Blood Pressure
Time frame: 8 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sodium Bicarbonate | Systolic Blood Pressure | 127 mmHg |
| Placebos | Systolic Blood Pressure | 129 mmHg |