Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT01574157
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01574157
Study Brief:
Protocol Section:
NCT01574157