Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) (BASE)

Number of Subjects in Study Archive: 192
Study Design: Interventional
Conditions: Kidney Diseases
Division: KUH
Duration: September 2015 – Present
# Recruitment Centers: 7
Treatment: Sodium bicarbonate
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL: https://clinicaltrials.gov/ct2/show/NCT02521181
Data Package Version Number: 1 (October 6, 2020)
DOI: 10.58020/agds-b607

How to cite this dataset: Gassman, Jennifer (2023). Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) (V1) [Dataset]. NIDDK Central Repository. https://doi.org/10.58020/agds-b607

Data availability statement: Data from the Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) [(V1)/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/.

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

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.

Resources Available

Specimens and Study Datasets

Materials Available

Urine	4424
Plasma	3546
Serum	2047

Publications (0)

Study Documents


		Data_Dictionary (PDF) - 603.6 KB
		DSIC (PDF) - 214.6 KB
		Forms (PDF) - 7.0 MB
		Manual_of_Procedures (PDF) - 5.3 MB
		Protocol (PDF) - 1.0 MB
		Roadmap (PDF) - 148.5 KB

If you need accessible versions of documents, please email your request to NIDDK-CRsupport@niddk.nih.gov.

Home chevron_right Studies chevron_right Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR)