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New treatment option for Metabolic Acidosis
Official title Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT05005793
What this study is testing
What is Sodium bicarbonate?
Sodium bicarbonate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metabolic acidosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Lower serum bicarbonate levels, even within the normal laboratory range, in kidney transplant recipients (KTRs) are associated with an increased risk of graft loss, cardiovascular events and mortality. Because acid retention is common in KTRs, it is plausible that alkali therapy in KTRs may also result in improved vascular and graft function.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18-80 years
- Serum bicarbonate 16-24 mEq/L on 2 separate measurements (at least 1 day apart)
- Kidney transplant received 1 year prior to randomization
- eGFR ≥ 45 ml/min/1.73m2 by CKD-EPI equation
- Blood pressure \<130/80 mm Hg prior to randomization
You likely can't join if
- Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
- Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
- Uncontrolled hypertension
- Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening
- New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
- Nephrotic range proteinuria (urine complement activation fragment measurements may not be accurate with severe proteinuria)
See the full eligibility criteria
- Age 18-80 years
- Serum bicarbonate 16-24 mEq/L on 2 separate measurements (at least 1 day apart)
- Kidney transplant received 1 year prior to randomization
- eGFR ≥ 45 ml/min/1.73m2 by CKD-EPI equation
- Blood pressure \<130/80 mm Hg prior to randomization
- BMI \< 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
- Able to provide consent
- Immunosuppression regimen consisting of tacrolimus, mycophenolate mofetil and prednisone (95% of patients at University of Colorado are on this regimen)
- Stable immunosuppression regimen for at least three months prior to randomization
- Stable anti-hypertensive regimen for at least one month prior to randomization
- Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).
- Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
- Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
- Uncontrolled hypertension
- Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening
- New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
- Nephrotic range proteinuria (urine complement activation fragment measurements may not be accurate with severe proteinuria)
- Factors judged to limit adherence to interventions
- Current participation in another research study
- Pregnancy or planning to become pregnant or currently breastfeeding
- Chronic use of supplemental oxygen
- Use of anticoagulants
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.