N/A
N=74
Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
Chronic Renal Insufficiency · Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01574157 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1) — 7.6; -4.4 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sodium bicarbonate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1) |
7.6; -4.4 | — |
| SECONDARY Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1) |
-11.4; -1.5 | — |
| SECONDARY Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL) |
-28.5; 5.9 | — |
| SECONDARY Change in Urinary Levels of Fibronectin |
8.8; 1.1 | — |
| SECONDARY Change in Urinary Albumin Levels |
21.1; 11.9 | — |
| SECONDARY Change in Estimated Glomerular Filtration (eGFR) |
1.96; -1.41 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT01574157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.