Alkali therapy for improving kidney transplant outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of sodium bicarbonate therapy on vascular and graft function in kidney transplant recipients (KTRs) who have low serum bicarbonate levels. Conducted as a randomized, double-blinded, placebo-controlled trial, it will enroll 120 KTRs and assess the impact of bicarbonate treatment over 12 months. The hypothesis is that alkali therapy may enhance graft function and reduce cardiovascular risks by decreasing complement activation. Participants will be closely monitored for changes in surrogate markers of cardiovascular disease and graft health.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Jessica Kendrick, MD MPH — University of Colorado Denver | Anschutz
• Study coordinator: Jessica Kendrick, MD MPH
• Email: jessica.kendrick@ucdenver.edu
• Phone: 3037244837

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.