Actively Recruiting
Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant
Led by University of Colorado, Denver · Updated on 2025-05-29
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of alkali therapy on kidney transplant recipients (KTRs) who often have lower serum bicarbonate levels within the normal range. This condition is linked to higher risks of graft loss, cardiovascular events, and mortality. The study aims to determine whether sodium bicarbonate treatment can improve vascular and graft function by reducing complement activation in these patients. The trial is a randomized, double-blinded, placebo-controlled study lasting 12 months, involving 120 KTRs. Participants will receive either oral sodium bicarbonate or a placebo at a dose of 0.5 mEq per kg of lean body weight per day. The study compares these two groups to assess changes in vascular and kidney graft function over time. Participants will be closely monitored at baseline and after 12 months with tests including brachial artery flow-mediated dilation, artery stiffness and compliance, tubular atrophy, plasma and urine complement activation fragments, and interstitial fibrosis. The study will track these markers to evaluate treatment effects, with safety and adherence monitored throughout. The total duration for each participant is one year.
CONDITIONS
Brief Title
Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Serum bicarbonate 16-24 mEq/L on two separate measurements at least 1 day apart
- Kidney transplant received at least 1 year prior to randomization
- Estimated glomerular filtration rate (eGFR) of 45 ml/min/1.73m2 or higher by CKD-EPI equation
- Blood pressure less than 130/80 mm Hg prior to randomization
- Body mass index (BMI) less than 40 kg/m2
- Able to provide consent
- Immunosuppression regimen including tacrolimus, mycophenolate mofetil, and prednisone
- Stable immunosuppression regimen for at least 3 months before randomization
- Stable anti-hypertensive regimen for at least 1 month before randomization
- Not taking medications that interact with study agents (e.g., sildenafil)
You will not qualify if you...
- Life expectancy less than 1 year due to significant comorbid conditions
- Use of chronic daily oral alkali (including sodium bicarbonate, calcium carbonate, or baking soda) within the last 3 months
- Uncontrolled hypertension
- Serum potassium less than 3.3 or 5.5 mEq/L or higher at screening
- New York Heart Association Class 3 or 4 heart failure symptoms, ejection fraction 40% or less, or recent hospital admission for heart failure within 3 months
- Nephrotic range proteinuria
- Factors limiting adherence to the study treatments
- Current participation in another research study
- Pregnancy, planning to become pregnant, or breastfeeding
- Chronic use of supplemental oxygen
- Use of anticoagulants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive oral sodium bicarbonate or placebo daily to evaluate effects on vascular and graft function.
Baseline visit and follow-up visits during treatment
Trial Site Locations
Total: 1 location
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Jessica Kendrick, MD MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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