Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK087783 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium bicarbonate | Experimental | 0.4 mEq/kg/day ideal body weight to be taken once a day |
|
| Placebo | Placebo Comparator | placebo dosage/frequency equivalent to sodium bicarbonate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Drug | 0.4 mEq/kg/day ideal body weight to be taken once a day |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hand-grip Strength | Hand-grip strength will be measured in all participants | 2 year |
| Estimated GFR | Estimated GFR | 2 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Hostetter, MD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States | ||
| Case Western Reserve University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34784301 | Derived | Brightwell CR, Kulkarni AS, Paredes W, Zhang K, Perkins JB, Gatlin KJ, Custodio M, Farooq H, Zaidi B, Pai R, Buttar RS, Tang Y, Melamed ML, Hostetter TH, Pessin JE, Hawkins M, Fry CS, Abramowitz MK. Muscle fibrosis and maladaptation occur progressively in CKD and are rescued by dialysis. JCI Insight. 2021 Dec 22;6(24):e150112. doi: 10.1172/jci.insight.150112. | |
| 31699517 | Derived | Melamed ML, Horwitz EJ, Dobre MA, Abramowitz MK, Zhang L, Lo Y, Mitch WE, Hostetter TH. Effects of Sodium Bicarbonate in CKD Stages 3 and 4: A Randomized, Placebo-Controlled, Multicenter Clinical Trial. Am J Kidney Dis. 2020 Feb;75(2):225-234. doi: 10.1053/j.ajkd.2019.07.016. Epub 2019 Nov 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo | placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Posted | Mean | Standard Deviation | seconds | 2 year |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All-cause hospitalization | General disorders | Systematic Assessment | Hospitalizations were collected, not cause of hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serum bicarbonate >=30 | Renal and urinary disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michal Melamed, MD | Albert Einstein College of Medicine | 718-430-2496 | michal.melamed@einstein.yu.edu |
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000138 | Acidosis |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
To be taken on the same schedule as the active arm |
|
| 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 |
| Cleveland |
| Ohio |
| 44106 |
| United States |
| Lost to Follow-up |
|
| Death |
|
| Initiated dialysis |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Serum bicarbonate | Mean | Standard Deviation | mEq/L |
|
| estimated glomerular filtration rate (eGFR) | Mean | Standard Deviation | ml/min/1.73m2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | DEXA of Wrist | The investigators will evaluate changes in bone mineral density at the wrist. | Posted | Mean | Standard Deviation | g/cm2 | 2 year |
|
|
|
| Secondary | Hand-grip Strength | Hand-grip strength will be measured in all participants | Posted | Mean | Standard Deviation | kg | 2 year |
|
|
|
| Secondary | Estimated GFR | Estimated GFR | Posted | Mean | Standard Deviation | ml/min/1.73m2 | 2 year |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 2 year |
|
|
|
| 1 |
| 74 |
| 20 |
| 74 |
| 29 |
| 74 |
| EG001 | Placebo | placebo dosage/frequency equivalent to sodium bicarbonate Placebo: To be taken on the same schedule as the active arm | 0 | 75 | 15 | 75 | 41 | 75 |
|
| Serum bicarbonate <=18 | Renal and urinary disorders | Systematic Assessment |
|
| Serum potassium <=3.5 | Renal and urinary disorders | Systematic Assessment |
|
| Serum potassium >= 5.0 mEq/L | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |