Chronic Kidney Disease, Metabolic Acidosis
Conditions
Keywords
Alkali, Sodium bicarbonate, Kidney disease, Acidosis
Brief 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.
Interventions
DRUGSodium bicarbonate
0.4 mEq/kg/day ideal body weight to be taken once a day
DRUGPlacebo
To be taken on the same schedule as the active arm
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times | 2 year | Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups. |
| DEXA of Wrist | 2 year | The investigators will evaluate changes in bone mineral density at the wrist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand-grip Strength | 2 year | Hand-grip strength will be measured in all participants |
| Estimated GFR | 2 year | Estimated GFR |
| Quality of Life - Physical Function Domain | 2 year | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sodium Bicarbonate 0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day | 74 |
| Placebo placebo dosage/frequency equivalent to sodium bicarbonate
Placebo: To be taken on the same schedule as the active arm | 75 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Initiated dialysis | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 3 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Withdrawal by Subject | 15 | 11 |
Baseline characteristics
| Characteristic | Sodium Bicarbonate | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 14.1 | 61.6 years STANDARD_DEVIATION 10.9 | 61 years STANDARD_DEVIATION 12.6 |
| estimated glomerular filtration rate (eGFR) | 36.2 ml/min/1.73m2 STANDARD_DEVIATION 11.1 | 36.4 ml/min/1.73m2 STANDARD_DEVIATION 11.4 | 36.3 ml/min/1.73m2 STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 10 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 63 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 47 Participants | 86 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 12 Participants | 23 Participants |
| Race (NIH/OMB) White | 24 Participants | 16 Participants | 40 Participants |
| Serum bicarbonate | 24 mEq/L STANDARD_DEVIATION 2.2 | 24.1 mEq/L STANDARD_DEVIATION 2.6 | 24 mEq/L STANDARD_DEVIATION 2.2 |
| Sex: Female, Male Female | 38 Participants | 42 Participants | 80 Participants |
| Sex: Female, Male Male | 36 Participants | 33 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 74 | 0 / 75 |
| other Total, other adverse events | 29 / 74 | 41 / 75 |
| serious Total, serious adverse events | 20 / 74 | 15 / 75 |
Outcome results
Primary
DEXA of Wrist
The investigators will evaluate changes in bone mineral density at the wrist.
Time frame: 2 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Bicarbonate | DEXA of Wrist | 0.75 g/cm2 | Standard Deviation 0.23 |
| Placebo | DEXA of Wrist | 0.73 g/cm2 | Standard Deviation 0.17 |
Primary
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.
Time frame: 2 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Bicarbonate | Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times | 23.8 seconds | Standard Deviation 5.8 |
| Placebo | Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times | 22.9 seconds | Standard Deviation 6.5 |
Secondary
Estimated GFR
Estimated GFR
Time frame: 2 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Bicarbonate | Estimated GFR | 38.5 ml/min/1.73m2 | Standard Deviation 17.7 |
| Placebo | Estimated GFR | 36.3 ml/min/1.73m2 | Standard Deviation 14.5 |
Secondary
Hand-grip Strength
Hand-grip strength will be measured in all participants
Time frame: 2 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Bicarbonate | Hand-grip Strength | 27.3 kg | Standard Deviation 9.8 |
| Placebo | Hand-grip Strength | 24.9 kg | Standard Deviation 10.2 |
Secondary
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.
Time frame: 2 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Bicarbonate | Quality of Life - Physical Function Domain | 40 score on a scale | Standard Deviation 12 |
| Placebo | Quality of Life - Physical Function Domain | 43 score on a scale | Standard Deviation 11 |