RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-12-01
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05005793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-80 years
  2. * Serum bicarbonate 16-24 mEq/L on 2 separate measurements (at least 1 day apart)
  3. * Kidney transplant received 1 year prior to randomization
  4. * eGFR ≥ 45 ml/min/1.73m2 by CKD-EPI equation
  5. * Blood pressure \<130/80 mm Hg prior to randomization
  6. * BMI \< 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
  7. * Able to provide consent
  8. * Immunosuppression regimen consisting of tacrolimus, mycophenolate mofetil and prednisone (95% of patients at University of Colorado are on this regimen)
  9. * Stable immunosuppression regimen for at least three months prior to randomization
  10. * Stable anti-hypertensive regimen for at least one month prior to randomization
  11. * Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).
  1. * Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
  2. * Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
  3. * Uncontrolled hypertension
  4. * Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening
  5. * 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
  6. * Nephrotic range proteinuria (urine complement activation fragment measurements may not be accurate with severe proteinuria)
  7. * Factors judged to limit adherence to interventions
  8. * Current participation in another research study
  9. * Pregnancy or planning to become pregnant or currently breastfeeding
  10. * Chronic use of supplemental oxygen
  11. * Use of anticoagulants

Contacts and Locations

Study Contact

Jessica Kendrick, MD MPH
CONTACT
3037244837
jessica.kendrick@ucdenver.edu

Principal Investigator

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

Study Locations (Sites)

University of Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-01
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2021-12-01
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Metabolic Acidosis
  • Kidney Transplant; Complications
  • Vascular Diseases