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

Launched by UNIVERSITY OF COLORADO, DENVER · Aug 10, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of sodium bicarbonate therapy, a type of alkali treatment, on kidney transplant recipients (KTRs) who may have low levels of bicarbonate in their blood. Low bicarbonate levels can increase the risk of serious health issues like graft loss (the failure of the transplanted kidney), heart problems, and even death. The researchers want to see if giving sodium bicarbonate can improve blood vessel function and kidney transplant performance over a 12-month period. The study will involve 120 participants who will be randomly assigned to receive either the sodium bicarbonate treatment or a placebo (a treatment that looks the same but has no active ingredient).

To be eligible for the trial, participants must be between 18 and 80 years old, have had a kidney transplant at least one year ago, and have specific bicarbonate levels and kidney function measurements. They should also be on a stable medication routine for their transplant and blood pressure. Participants can expect to attend regular visits over the year for assessments and monitoring. It’s important to note that individuals with certain serious health conditions or those taking specific medications may not qualify for this study. This trial aims to find a potential new way to help improve the health of kidney transplant recipients.

Gender

ALL

Eligibility criteria

• 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