| Trial ID: | L0061 |
| Source ID: | NCT01574157
|
| Associated Drug: |
Sodium Bicarbonate
|
| Title: |
Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01574157/results
|
| Conditions: |
Chronic Renal Insufficiency|Diabetes Mellitus
|
| Interventions: |
DRUG: Sodium bicarbonate|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1), Urinary TGF-b1 is considered a marker of renal fibrosis, The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups. | Secondary: Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1), KIM-1 is a marker of of kidney injury., The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.|Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL), NGAL is a marker of kidney injury, The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.|Change in Urinary Levels of Fibronectin, Fibronectin is a marker of kidney injury., The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.|Change in Urinary Albumin Levels, Urinary albumin is a marker of kidney damage, The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.|Change in Estimated Glomerular Filtration (eGFR), eGFR is a measure of kidney function, The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
|
| Sponsor/Collaborators: |
Sponsor: VA Office of Research and Development
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
74
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-11-05
|
| Completion Date: |
2018-05-01
|
| Results First Posted: |
2019-08-28
|
| Last Update Posted: |
2019-08-28
|
| Locations: |
VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City, Utah, 84148, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01574157
|
