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Alkali Therapy for Kidney Transplant Recipients

This study is looking at whether taking sodium bicarbonate (an alkali therapy) can improve the health of your blood vessels and how well your transplanted kidney works. We know that even slightly lower levels of bicarbonate in your blood after a kidney transplant can increase risks to your kidney and heart. This study will give either oral sodium bicarbonate or a placebo (an inactive substance) to 120 kidney transplant recipients for 12 months. We'll measure changes in your blood vessel function to see if the treatment helps. You might be able to join if you are 18-80 years old, received a kidney transplant at least a year ago, have specific blood bicarbonate levels, and meet other health criteria.

Study design
This is a randomized, double-blinded, placebo-controlled study involving 120 participants. This means participants are randomly assigned to receive either the active treatment or a placebo, and neither you nor the study team will know which you are receiving.
What's involved
Participants will take either oral sodium bicarbonate or a placebo daily for 12 months. Your brachial artery flow-mediated dilation will be measured at the beginning and end of the 12-month study period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months, with the primary measurement taken at the end of this period.

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NCT05005793

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

Recruiting
PHASE4Ages 18–80InterventionalTreatment
University of Colorado, Denver
~120 participants
Updated 2025-05-29 on ClinicalTrials.gov
What's tested:Sodium bicarbonatePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Brachial artery flow mediated dilation at 12 months
Measured over Baseline and 12 months

Conditions

Metabolic Acidosis
Kidney Transplant; Complications
Vascular Diseases

Explore related trials

Kidney TransplantationMetabolic AcidosisVascular Disorder

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Jessica Kendrick, MD MPH · PRINCIPAL_INVESTIGATOR · University of Colorado Denver | Anschutz

Who to contact

Jessica Kendrick, MD MPH
[email protected]
3037244837
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Brachial artery flow mediated dilation at 12 monthsBaseline and 12 months

    Brachial artery FMD will be determined using high-resolution ultrasonographyECG-gated end-diastolic ultrasound images and Doppler flow of the brachial artery will be acquired during baseline and FMD conditions. For FMD, reactive hyperemia will be produced by inflating a pediatric BP cuff around the forearm to 250 mmHg for 5 minutes followed by rapid deflation.