Clinical trial NCT01574157: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Insufficiency
Diabetes Mellitus
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-04-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)
timeFrame: The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups.
Secondary outcomes:
measure: Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)
timeFrame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
measure: Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)
timeFrame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
measure: Change in Urinary Levels of Fibronectin
timeFrame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
measure: Change in Urinary Albumin Levels
timeFrame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
measure: Change in Estimated Glomerular Filtration (eGFR)
timeFrame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
Study officials:
affiliation: VA Salt Lake City Health Care System, Salt Lake City, UT
name: Kalani L Raphael, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.