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Data from the Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) (BASE) [(Version 1) https://doi.org/10.58020/agds-b607] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
The BASE study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the BASE (https://doi.org/10.58020/agds-b607) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the BASE study and does not necessarily reflect the opinions or views of the BASE study, NIDDK-CR, or NIDDK.
Data Package Version
Version 1 (Updated on: Oct 06, 2020)
Resource Availability
- Data Available for Request
- Specimens Available for Request
General Description
Sodium bicarbonate 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.
Objectives
To 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 in individuals with chronic kidney disease.
Outcome Measure
Primary Outcome Measures:
- Percentage of participants in each dose arm who are prescribed (i) full randomized sodium bicarbonate dose per protocol at end of 28 weeks and (ii) at least 25% of randomized sodium bicarbonate dose per protocol at end of 28 weeks.
Secondary Outcome Measures:
- Change in Urinary ammonium excretion from baseline to 28 weeks
Eligibility Criteria
Inclusion Criteria:
- Patients must be 18 years or older with moderate to severe chronic kidney disease at the time of screening to participate in this study.
Exclusion Criteria:
- Patients less than 18 years or older and/or do not have severe chronic kidney disease at the time of screening may not participate in this study.
Outcome
This study is ongoing.
Research Area
Kidney Disease
Study Type
Interventional
Study Sites
7
Study Start Date
2015-10
Study End Date
2018-06
Condition
Chronic Kidney Disease
Clinical Trials URL
Keywords
Cronic Kidney Disease (CKD), Sodium Bicarconate, Kidney Disease, Estimated Glomerular Filtration Rate (EGFR)
NIDDK Division
Division of Kidney, Urologic, and Hematologic Diseases
272
Participants
Target Population
Adults
Document Name | Description | Document Type | File Format | Compliance | Download |
|---|---|---|---|---|---|
Non-Public Documents (0)
There are currently no non-public documents available
Datasets (41)
Dataset Name | Description | # of Records | # of Variables | File Format(s) |
|---|---|---|---|---|
Event Review Committee Hospitalizations Review Dataset | Captures event review committee hospitalizations review data | 38 | sas7bdat (384 KB); csv (4.21 KB) | |
Local Lab Serum Pregnancy Test Results Dataset | Captures local lab serum pregnancy test results data | 14 | sas7bdat (128 KB); csv (1.07 KB) | |
Event Review Committee Death Review Dataset | Captures event review committee death review data | 1 | sas7bdat (256 KB); csv (309 B) | |
Baseline (Pre-Randomization) Drop-Out Dataset | Captures baseline pre-randomization drop-out data | 65 | sas7bdat (128 KB); csv (4.25 KB) | |
Initiation of Chronic Dialysis or Transplant Dataset | Captures initiation of chronic dialysis or transplant data | 1 | sas7bdat (128 KB); csv (188 B) | |
Hospitalization Notification Dataset | Captures hospitalization notification data | 38 | sas7bdat (128 KB); csv (2.8 KB) | |
Between Visit Phone Medication Change Dataset | Captures between visit phone medication change data | 60 | sas7bdat (128 KB); csv (4.87 KB) | |
Death Details Dataset | Captures death details data | 1 | sas7bdat (256 KB); csv (1.54 KB) | |
Follow-Up Pill Dispensing and Counting Dataset | Captures follow-up pill dispensing and counting data | 947 | sas7bdat (320 KB); csv (130.34 KB) | |
Baseline Pill Dispensing Dataset | Captures baseline pill dispensing data | 207 | sas7bdat (128 KB); csv (17.92 KB) | |
Screening Dataset | Captures screening data | 272 | sas7bdat (1 MB); csv (102.77 KB) | |
GI Symptoms and Other AEs Dataset | Captures gastrointestinal symptoms and other adverse events data | 1559 | sas7bdat (640 KB); csv (246.56 KB) | |
Event Review Committee SAEs that are not Hospitalizations or Death Review Dataset | Captures event review committee serious adverse events that are not hospitalizations or deaths review data | 1 | sas7bdat (256 KB); csv (330 B) | |
Litholink 24-hour Urine Mailing Dataset | Captures Litholink 24-hour urine mailing data | 580 | sas7bdat (192 KB); csv (83.98 KB) | |
Randomization Dataset | Captures randomization data | 194 | sas7bdat (128 KB); csv (10.01 KB) | |
NIDDK Biorepository Serum and Plasma Mailing Dataset | Captures NIDDK Biorepository serum and plasma mailing data | 509 | sas7bdat (128 KB); csv (53.86 KB) | |
Death Codes Dataset | Captures death codes data | 249 | sas7bdat (128 KB); csv (10.5 KB) | |
Local Lab Spot Urine Results | Captures local lab spot urine results data | 799 | sas7bdat (192 KB); csv (77.01 KB) | |
Initial Pill Dispensing Dataset | Captures initial pill dispensing data | 194 | sas7bdat (128 KB); csv (16.86 KB) | |
Study Closeout Dataset | Captures study closeout data | 192 | sas7bdat (128 KB); csv (13.81 KB) | |
Co-Morbidity and Medical History Dataset | Captures co-morbidity and medical history data | 213 | sas7bdat (192 KB); csv (28.34 KB) | |
Hospitalization Detail Dataset | Captures hospitalization detail data | 38 | sas7bdat (384 KB); csv (25.39 KB) | |
Visit/Phone Visit Dataset | Captures visit/phone visit data | 2260 | sas7bdat (960 KB); csv (440.62 KB) | |
Local Lab Serum Results Dataset | Captures local lab serum results data | 1808 | sas7bdat (384 KB); csv (212.44 KB) | |
NIDDK Biorepository Random (Spot) Urine Mailing | Captures NIDDK Biorepository random (spot) urine mailing data | 494 | sas7bdat (128 KB); csv (54.2 KB) | |
Baseline Demographics, Employment, and Income Dataset | Captures baseline demographics, employment, and income data | 215 | sas7bdat (128 KB); csv (24.33 KB) | |
Details of SAEs that are Not Hospitalizations or Deaths Dataset | Captures details of serious adverse events other than hospitalizations or deaths | 1 | sas7bdat (256 KB); csv (1.1 KB) | |
Participant End of Study Questionnaire Dataset | Captures participant end of study questionnaire data | 183 | sas7bdat (128 KB); csv (15.19 KB) | |
Event Information Sent to the DCC Dataset | Captures event information sent to the data coordinating center | 41 | sas7bdat (256 KB); csv (4.79 KB) | |
Baseline Pill Count Dataset | Captures baseline pill count data | 228 | sas7bdat (128 KB); csv (24.33 KB) | |
Local Blood Gas Sub Study Dataset | Captures local blood gas sub-study data | 66 | sas7bdat (128 KB); csv (9.05 KB) | |
GI Symptoms and Other AEs DTL Dataset | Captures gastrointestinal symptoms and other adverse events data | 478 | sas7bdat (256 KB); csv (31.51 KB) | |
Concomitant Medications Dataset | Captures concomitant medications data | 2163 | sas7bdat (384 KB); csv (176.57 KB) | |
Re-Enrollment of a Previously Enrolled Participant Dataset | Captures re-enrollment of a previously enrolled participant data | 3 | sas7bdat (128 KB); csv (272 B) | |
Hospital Codes Dataset | Captures hospital codes data | 919 | sas7bdat (192 KB); csv (50.83 KB) | |
Death Notification Dataset | Captures death notification data | 1 | sas7bdat (128 KB); csv (214 B) | |
Extra Lab Measurements Dataset | Captures extra lab measurements data | 4 | sas7bdat (128 KB); csv (634 B) | |
Concomitant Medications DTL Dataset | Captures concomitant medications data | 22818 | sas7bdat (3.75 MB); csv (2.27 MB) | |
Litholink Lab 24-hour Urine Results Dataset | Captures Litholink 24-hour urine results data | 574 | sas7bdat (192 KB); csv (82.97 KB) | |
Hospitalization Detail DTL Dataset | Captures hospitalization detail data | 15 | sas7bdat (128 KB); csv (1.34 KB) | |
Details of SAEs that are Not Hospitalizations or Deaths DTL Dataset | Captures details of serious adverse events other than hospitalizations or deaths | sas7bdat (128 KB); csv (73 B) |
Specimens (10,017)
Specimen | Count |
|---|---|
| Plasma | 3546 |
| Serum | 2047 |
| Urine | 4424 |