Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients

  • STATUS
    Recruiting
  • End date
    Aug 31, 2026
  • participants needed
    120
  • sponsor
    University of Colorado, Denver
Updated on 20 December 2021

Summary

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. The investigators will perform a randomized, double-blinded, placebo-controlled, 12 month study in 120 KTRs to examine the effect of sodium bicarbonate therapy on surrogate markers of CVD and graft function. The overall hypothesis is that treatment with bicarbonate will improve indicators of vascular and graft function in KTRs by decreasing complement activation.

Details
Condition Metabolic Acidosis, Kidney Transplant; Complications, Vascular Diseases
Treatment Placebo, Sodium bicarbonate
Clinical Study IdentifierNCT05005793
SponsorUniversity of Colorado, Denver
Last Modified on20 December 2021

Eligibility

Yes No Not Sure

Inclusion 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)

Exclusion Criteria

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
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