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NIH: National Institute of Diabetes and Digestive and Kidney Diseases
NIDDK Central Repository
Citation
Gassman, Jennifer (2020). Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) (BASE) (Version 1) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/agds-b607
Data Availability Statement
Data from 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/.
Acknowledgement Statement
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
Publications
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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.

Primary 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
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

https://clinicaltrials.gov/ct2/show/NCT02521181

Keywords

Sodium Bicarconate, Kidney Disease, Estimated Glomerular Filtration Rate (EGFR), Cronic Kidney Disease (CKD)

NIDDK Division

Division of Kidney, Urologic, and Hematologic Diseases

272
Participants
Target Population
Adults

Public Documents Table
Document Name
Description
Document Type
File Format
Compliance
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Permitted Use(s) of the Resources
  • Use is allowed for any research purpose
Non-Public Documents (0)
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Datasets (41)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Event Review Committee Hospitalizations Review Dataset
Captures event review committee hospitalizations review data38sas7bdat (384 KB); csv (4.21 KB)
Local Lab Serum Pregnancy Test Results Dataset
Captures local lab serum pregnancy test results data14sas7bdat (128 KB); csv (1.07 KB)
Event Review Committee Death Review Dataset
Captures event review committee death review data1sas7bdat (256 KB); csv (309 B)
Baseline (Pre-Randomization) Drop-Out Dataset
Captures baseline pre-randomization drop-out data65sas7bdat (128 KB); csv (4.25 KB)
Initiation of Chronic Dialysis or Transplant Dataset
Captures initiation of chronic dialysis or transplant data1sas7bdat (128 KB); csv (188 B)
Hospitalization Notification Dataset
Captures hospitalization notification data38sas7bdat (128 KB); csv (2.8 KB)
Between Visit Phone Medication Change Dataset
Captures between visit phone medication change data60sas7bdat (128 KB); csv (4.87 KB)
Death Details Dataset
Captures death details data1sas7bdat (256 KB); csv (1.54 KB)
Follow-Up Pill Dispensing and Counting Dataset
Captures follow-up pill dispensing and counting data947sas7bdat (320 KB); csv (130.34 KB)
Baseline Pill Dispensing Dataset
Captures baseline pill dispensing data207sas7bdat (128 KB); csv (17.92 KB)
Screening Dataset
Captures screening data272sas7bdat (1 MB); csv (102.77 KB)
GI Symptoms and Other AEs Dataset
Captures gastrointestinal symptoms and other adverse events data1559sas7bdat (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 data1sas7bdat (256 KB); csv (330 B)
Litholink 24-hour Urine Mailing Dataset
Captures Litholink 24-hour urine mailing data580sas7bdat (192 KB); csv (83.98 KB)
Randomization Dataset
Captures randomization data194sas7bdat (128 KB); csv (10.01 KB)
NIDDK Biorepository Serum and Plasma Mailing Dataset
Captures NIDDK Biorepository serum and plasma mailing data509sas7bdat (128 KB); csv (53.86 KB)
Death Codes Dataset
Captures death codes data249sas7bdat (128 KB); csv (10.5 KB)
Local Lab Spot Urine Results
Captures local lab spot urine results data799sas7bdat (192 KB); csv (77.01 KB)
Initial Pill Dispensing Dataset
Captures initial pill dispensing data194sas7bdat (128 KB); csv (16.86 KB)
Study Closeout Dataset
Captures study closeout data192sas7bdat (128 KB); csv (13.81 KB)
Co-Morbidity and Medical History Dataset
Captures co-morbidity and medical history data213sas7bdat (192 KB); csv (28.34 KB)
Hospitalization Detail Dataset
Captures hospitalization detail data38sas7bdat (384 KB); csv (25.39 KB)
Visit/Phone Visit Dataset
Captures visit/phone visit data2260sas7bdat (960 KB); csv (440.62 KB)
Local Lab Serum Results Dataset
Captures local lab serum results data1808sas7bdat (384 KB); csv (212.44 KB)
NIDDK Biorepository Random (Spot) Urine Mailing
Captures NIDDK Biorepository random (spot) urine mailing data494sas7bdat (128 KB); csv (54.2 KB)
Baseline Demographics, Employment, and Income Dataset
Captures baseline demographics, employment, and income data215sas7bdat (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 deaths1sas7bdat (256 KB); csv (1.1 KB)
Participant End of Study Questionnaire Dataset
Captures participant end of study questionnaire data183sas7bdat (128 KB); csv (15.19 KB)
Event Information Sent to the DCC Dataset
Captures event information sent to the data coordinating center41sas7bdat (256 KB); csv (4.79 KB)
Baseline Pill Count Dataset
Captures baseline pill count data228sas7bdat (128 KB); csv (24.33 KB)
Local Blood Gas Sub Study Dataset
Captures local blood gas sub-study data66sas7bdat (128 KB); csv (9.05 KB)
GI Symptoms and Other AEs DTL Dataset
Captures gastrointestinal symptoms and other adverse events data478sas7bdat (256 KB); csv (31.51 KB)
Concomitant Medications Dataset
Captures concomitant medications data2163sas7bdat (384 KB); csv (176.57 KB)
Re-Enrollment of a Previously Enrolled Participant Dataset
Captures re-enrollment of a previously enrolled participant data3sas7bdat (128 KB); csv (272 B)
Hospital Codes Dataset
Captures hospital codes data919sas7bdat (192 KB); csv (50.83 KB)
Death Notification Dataset
Captures death notification data1sas7bdat (128 KB); csv (214 B)
Extra Lab Measurements Dataset
Captures extra lab measurements data4sas7bdat (128 KB); csv (634 B)
Concomitant Medications DTL Dataset
Captures concomitant medications data22818sas7bdat (3.75 MB); csv (2.27 MB)
Litholink Lab 24-hour Urine Results Dataset
Captures Litholink 24-hour urine results data574sas7bdat (192 KB); csv (82.97 KB)
Hospitalization Detail DTL Dataset
Captures hospitalization detail data15sas7bdat (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 deathssas7bdat (128 KB); csv (73 B)
Specimens (10,017)
Specimens Table
Specimen
Count
Plasma3546
Serum2047
Urine4424