Back to resultsInvestigations of the Optimum Serum Bicarbonate Level in Renal Disease.
Primary Purpose
Chronic Renal Insufficiency, Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sodium bicarbonate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Veteran
- Age older than 18 years
- Diabetes mellitus
- Serum bicarbonate 22 - 28 mmol/L on the most recent measurement within the past six months
- Stage 2, 3, or 4 CKD (defined as estimated glomerular filtration rate (eGFR) 15 - 89 ml/min/1.73m2 using the CKD-Epidemiology equation)
- Urinary albumin:creatinine ratio > 30 mg/gm on the most recent sample within the past 12 months.
Exclusion Criteria:
- Lean body weight > 100 kg
- Use of oral medications typically prescribed to raise low serum bicarbonate levels (i.e. sodium bicarbonate, sodium citrate, potassium citrate).
- Serum potassium < 3.5 meq/L at enrollment visit
- Use of 5 or more antihypertensive agents, regardless of the indications of each agent
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at the enrollment or baseline visit
- Diagnosis of congestive heart failure with current, active Class III or IV New York Heart Association symptoms.
- Significant fluid overload such that it is unsafe in the opinion of the PI for the patient to participate in the trial
- chronic gastrointestinal disorder or any other factors judged to be likely to limit adherence to interventions (i.e. alcoholism, a history of missing clinic visits)
- Chronic immunosuppressive therapy for transplanted organs or other indications
Individuals who are currently a member of a vulnerable population (I.e. incarcerated, pregnant).
11.Currently participating in another interventional research study
Sites / Locations
- VA Salt Lake City Health Care System, Salt Lake City, UT
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sodium Bicarbonate
Placebo
Arm Description
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
Outcomes
Primary Outcome Measures
Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)
Urinary TGF-b1 is considered a marker of renal fibrosis
Secondary Outcome Measures
Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)
KIM-1 is a marker of of kidney injury.
Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)
NGAL is a marker of kidney injury
Change in Urinary Levels of Fibronectin
Fibronectin is a marker of kidney injury.
Change in Urinary Albumin Levels
Urinary albumin is a marker of kidney damage
Change in Estimated Glomerular Filtration (eGFR)
eGFR is a measure of kidney function
Full Information
NCT ID
NCT01574157
First Posted
March 27, 2012
Last Updated
August 12, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01574157
Brief Title
Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
Official Title
Investigations of the Optimum Serum Bicarbonate Level in Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 5, 2012 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Insufficiency, Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Bicarbonate
Arm Type
Active Comparator
Arm Description
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
Primary Outcome Measure Information:
Title
Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)
Description
Urinary TGF-b1 is considered a marker of renal fibrosis
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.
Secondary Outcome Measure Information:
Title
Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)
Description
KIM-1 is a marker of of kidney injury.
Time Frame
The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Title
Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)
Description
NGAL is a marker of kidney injury
Time Frame
The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Title
Change in Urinary Levels of Fibronectin
Description
Fibronectin is a marker of kidney injury.
Time Frame
The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Title
Change in Urinary Albumin Levels
Description
Urinary albumin is a marker of kidney damage
Time Frame
The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Title
Change in Estimated Glomerular Filtration (eGFR)
Description
eGFR is a measure of kidney function
Time Frame
The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Veteran
Age older than 18 years
Diabetes mellitus
Serum bicarbonate 22 - 28 mmol/L on the most recent measurement within the past six months
Stage 2, 3, or 4 CKD (defined as estimated glomerular filtration rate (eGFR) 15 - 89 ml/min/1.73m2 using the CKD-Epidemiology equation)
Urinary albumin:creatinine ratio > 30 mg/gm on the most recent sample within the past 12 months.
Exclusion Criteria:
Lean body weight > 100 kg
Use of oral medications typically prescribed to raise low serum bicarbonate levels (i.e. sodium bicarbonate, sodium citrate, potassium citrate).
Serum potassium < 3.5 meq/L at enrollment visit
Use of 5 or more antihypertensive agents, regardless of the indications of each agent
Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at the enrollment or baseline visit
Diagnosis of congestive heart failure with current, active Class III or IV New York Heart Association symptoms.
Significant fluid overload such that it is unsafe in the opinion of the PI for the patient to participate in the trial
chronic gastrointestinal disorder or any other factors judged to be likely to limit adherence to interventions (i.e. alcoholism, a history of missing clinic visits)
Chronic immunosuppressive therapy for transplanted organs or other indications
Individuals who are currently a member of a vulnerable population (I.e. incarcerated, pregnant).
11.Currently participating in another interventional research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalani L Raphael, MD
Organizational Affiliation
VA Salt Lake City Health Care System, Salt Lake City, UT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35369374
Citation
Gardner J, Tuttle K, Raphael KL. Influence of Medications Containing Acid Salts on Serum Bicarbonate in CKD. Kidney360. 2020 Mar 31;1(5):330-336. doi: 10.34067/KID.0000532019. eCollection 2020 May 28.
Results Reference
derived
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Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
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