Actively Recruiting
Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
Led by University of Colorado, Denver · Updated on 2025-05-29
120
Participants Needed
1
Research Sites
247 weeks
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
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.
CONDITIONS
Official 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 18-80 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 6 ml/min/1.73m2 by CKD-EPI equation
- Blood pressure <130/80 mm Hg prior to randomization
- BMI < 40 kg/m2
- Able to provide consent
- Immunosuppression regimen with tacrolimus, mycophenolate mofetil, and prednisone
- Stable immunosuppression regimen for at least 3 months prior to randomization
- Stable anti-hypertensive regimen for at least 1 month prior to randomization
- Not taking medications that interact with study agents such as sildenafil
You will not qualify if you...
- Life expectancy less than 1 year due to significant comorbid conditions
- Use of chronic daily oral alkali in the last 3 months
- Uncontrolled hypertension
- Serum potassium less than 3.3 or greater than or equal to 5.5 mEq/L at screening
- New York Heart Association Class 3 or 4 heart failure symptoms, ejection fraction 40%, or recent hospital admission for heart failure
- Nephrotic range proteinuria
- Factors limiting adherence to interventions
- Current participation in another research study
- Pregnancy, planning pregnancy, or breastfeeding
- Chronic use of supplemental oxygen
- Use of anticoagulants
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Jessica Kendrick, MD MPH
CONTACT
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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