Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
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ClinicalTrials.gov Identifier: NCT01574157 |
Recruitment Status :
Completed
First Posted : April 10, 2012
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
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Sponsor:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development
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Tracking Information | |||||||
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First Submitted Date ICMJE | March 27, 2012 | ||||||
First Posted Date ICMJE | April 10, 2012 | ||||||
Results First Submitted Date ICMJE | June 26, 2019 | ||||||
Results First Posted Date ICMJE | August 28, 2019 | ||||||
Last Update Posted Date | August 28, 2019 | ||||||
Actual Study Start Date ICMJE | November 5, 2012 | ||||||
Actual Primary Completion Date | May 1, 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1) [ Time Frame: The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups. ] Urinary TGF-b1 is considered a marker of renal fibrosis
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Original Primary Outcome Measures ICMJE |
Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1) [ Time Frame: The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value. ] Urinary TGF-b1 is considered a marker of renal fibrosis
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Change in urinary Bb and membrane attack complex (MAC) [ Time Frame: The mean of the 3-month and 6-month urinary Bb and MAC measurements will be compared to the baseline values. ] These are biomarkers of renal complement system activation
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Investigations of the Optimum Serum Bicarbonate Level in Renal Disease. | ||||||
Official Title ICMJE | Investigations of the Optimum Serum Bicarbonate Level in Renal Disease | ||||||
Brief Summary | The purpose of this study is to see if treatment with sodium bicarbonate will lower urine levels of proteins that are indicators of kidney damage in people with diabetes who also have chronic kidney disease. | ||||||
Detailed Description | Diabetic chronic kidney disease (CKD) is a common problem in Veterans and progresses to end-stage renal disease in many people. It is important to identify treatment strategies that will help prevent the progression of CKD to overt kidney failure. The purpose of this study is to see if sodium bicarbonate reduces urinary markers of kidney damage in Veterans with diabetic CKD and normal serum bicarbonate levels. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
74 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | May 1, 2018 | ||||||
Actual Primary Completion Date | May 1, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01574157 | ||||||
Other Study ID Numbers ICMJE | CLIN-002-11F | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | VA Office of Research and Development | ||||||
Study Sponsor ICMJE | VA Office of Research and Development | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | VA Office of Research and Development | ||||||
Verification Date | August 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |