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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK099877 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| The Cleveland Clinic | OTHER |
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The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight (LBW) per day. Sodium bicarbonate, also known as baking soda, may help prevent kidney failure in people with chronic kidney disease. However, the dose to prescribe in order to test this possibility in a clinical trial is uncertain. The BASE pilot clinical trial will help determine the best dose of sodium bicarbonate to prescribe in a future study that will test the long-term safety and efficacy of sodium bicarbonate as a treatment to preserve kidney function in individuals with chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower Dose Sodium Bicarbonate | Experimental | Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) |
|
| Higher Dose Sodium Bicarbonate | Experimental | Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) |
|
| Placebo | Placebo Comparator | Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower Dose Sodium Bicarbonate | Drug | Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Each Dose Arm Prescribed (i) Full Randomized Sodium Bicarbonate Dose at End of 28 Weeks & (ii) at Least 25% of Randomized Sodium Bicarbonate Dose at End of 28 Weeks as a Proportion of the Number Randomized to That Group | The prescribed dose for each participant at the end of 28 weeks will be determined by the safety and tolerability of each dose during the intervention period. The primary assessments will examine the percentage of participants in each dose arm who are prescribed (i) the full randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks and (ii) at least 25% of the randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks. The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight per day. | Baseline, 28 weeks |
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Inclusion Criteria:
Serum bicarbonate 20-28 mEq/L at screening (the average of the two most recent values in Baseline must be 20-28 mEq/L prior to randomization)
Moderate to severe chronic kidney disease (CKD) at the time of screening, defined as one of the following:
Blood pressure <160/100 mm Hg at screening (must be <150/100 mm Hg prior to randomization)
Lean body weight 38.0-96.0 kg at the time of screening
Age allowing legal consent without parental involvement (18-21 years, depending on individual state regulations)
Able to provide consent
Able to travel to study visits
Able to read English
In the opinion of the site investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations
In the opinion of the site investigator, medically stable
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael F. Flessner, MD, PhD | DKUHD, NIDDK, NIH | Study Director |
| John W. Kusek, PhD | DKUHD, NIDDK, NIH | Study Director |
| Linda Fried, MD, MPH | VA Pittsburgh Healthcare System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Nephrology Research | Denver | Colorado | 80230 | United States | ||
| George Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38170601 | Derived | Raphael KL, Katz R, Larive B, Kendrick C, Isakova T, Sprague S, Wolf M, Raj DS, Fried LF, Gassman J, Hoofnagle A, Cheung AK, Ix JH. Oral Sodium Bicarbonate and Bone Turnover in CKD: A Secondary Analysis of the BASE Pilot Trial. J Am Soc Nephrol. 2024 Jan 1;35(1):57-65. doi: 10.1681/ASN.0000000000000264. Epub 2023 Dec 4. |
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Patients were recruited from the CKD medical clinic patients of the recruiting centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lower Dose Sodium Bicarbonate | Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2016 |
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| Higher Dose Sodium Bicarbonate | Drug | Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day) |
|
| Placebo | Drug | Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate |
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| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Data Coordinating Center; Cleveland Clinic Foundation; Quantitative Health Sciences; 9500 Euclid Avenue | Cleveland | Ohio | 44195-5196 | United States |
| Baylor/Scott & White | Temple | Texas | 76502 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Utah VA | Salt Lake City | Utah | 84112 | United States |
| FG001 | Higher Dose Sodium Bicarbonate | Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day) |
| FG002 | Placebo | Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lower Dose Sodium Bicarbonate | Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day) |
| BG001 | Higher Dose Sodium Bicarbonate | Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day) |
| BG002 | Placebo | Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| CKD Stage | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes Mellitus | Count of Participants | Participants |
| ||||||||||||||||
| History of Heart Disease | Count of Participants | Participants |
| ||||||||||||||||
| Congestive Heart Failure | Count of Participants | Participants |
| ||||||||||||||||
| COPD | Count of Participants | Participants |
| ||||||||||||||||
| Smoking Status | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Lean Body Mass | Mean | Standard Deviation | kg |
| |||||||||||||||
| Systolic BP | Mean | Standard Deviation | mm Hg |
| |||||||||||||||
| Ace/ARB Use | Count of Participants | Participants |
| ||||||||||||||||
| eGFR | Mean | Standard Deviation | ml/min/1.73m^2 |
| |||||||||||||||
| Urine Albumin / Creatinine Ratio | Median | Inter-Quartile Range | g/mg |
| |||||||||||||||
| Serum Bicarbonate | Mean | Standard Deviation | meq/L |
| |||||||||||||||
| Serum Potassium | Mean | Standard Deviation | meq/L |
| |||||||||||||||
| Urinary Ammonium | Mean | Standard Deviation | mmol/day |
| |||||||||||||||
| Urinary PH | Mean | Standard Deviation | units on a scale |
| |||||||||||||||
| Estimated DIetary Protein Intake | Mean | Standard Deviation | g/day |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants in Each Dose Arm Prescribed (i) Full Randomized Sodium Bicarbonate Dose at End of 28 Weeks & (ii) at Least 25% of Randomized Sodium Bicarbonate Dose at End of 28 Weeks as a Proportion of the Number Randomized to That Group | The prescribed dose for each participant at the end of 28 weeks will be determined by the safety and tolerability of each dose during the intervention period. The primary assessments will examine the percentage of participants in each dose arm who are prescribed (i) the full randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks and (ii) at least 25% of the randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks. The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight per day. | Posted | Number | participants | Baseline, 28 weeks |
|
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|
32 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lower Dose Sodium Bicarbonate | Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day) | 0 | 52 | 5 | 52 | 40 | 52 |
| EG001 | Higher Dose Sodium Bicarbonate | Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day) | 0 | 90 | 16 | 90 | 74 | 90 |
| EG002 | Placebo | Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.) Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate | 1 | 52 | 7 | 52 | 42 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reached ESRD (Dialysis or Transplant) | Renal and urinary disorders | Systematic Assessment |
| ||
| Cardiovascular Hospitalizations | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal Hospitalizations | Gastrointestinal disorders | Systematic Assessment |
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| Infection Hospitalizations | Injury, poisoning and procedural complications | Systematic Assessment |
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| Renal Hospitalizations | Renal and urinary disorders | Systematic Assessment |
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| Malignancy Hospitalizations | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Injury Hospitalizations | Injury, poisoning and procedural complications | Systematic Assessment |
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| Respiratory Hospitalizations | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Musculoskeletal Hospitalizations | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Endocrine Disorder Hospitalizations | Endocrine disorders | Systematic Assessment |
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| Vascular Hospitalizations | Vascular disorders | Systematic Assessment |
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| Psychiatric Hospitalizations | Psychiatric disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe gastrointestinal symptoms | Gastrointestinal disorders | Systematic Assessment | Highest level of symptoms was severe |
| |
| Moderate gastrointestinal symptoms | Gastrointestinal disorders | Systematic Assessment | Highest level of symptoms is moderate |
| |
| Mild gastrointestinal symptoms | Gastrointestinal disorders | Systematic Assessment | Highest level of symptoms is mild |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer J. Gassman, PhD | Cleveland Clinic Foundation | (216) 444-9938 | gassmaj@ccf.org |
| Aug 14, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Stage 3B (eGFR 30-45) |
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| Stage 4 (eGFR 15-30) |
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| Former Smoker |
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| Current Smoker |
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