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Recruiting NCT05005793

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

Phase IV Interventional Metabolic Acidosis Kidney Transplant; Complications Vascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sodium bicarbonate, Placebo.
Who it may be relevant to
Registry conditions: Metabolic Acidosis, Kidney Transplant; Complications, Vascular Diseases. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Sodium bicarbonate
    Oral sodium bicarbonate at 0.5 mEq/kg-lean body weight/day
  • Drug Placebo
    Placebo at 0.5 mEq/kg-lean body weight/day

Primary outcome measures

  • Change in Brachial artery flow mediated dilation at 12 months [Time frame: Baseline and 12 months]
Secondary outcome measures (4)
  • Change in Large elastic artery stiffness and compliance at 12 months [Time frame: Baseline and 12 months]
  • Change in Tubular atrophy at 12 months [Time frame: Baseline and 12 months]
  • Change in participant plasma and urine complement activation fragment levels at 12 months [Time frame: Baseline and 12 months]
  • Change in interstitial fibrosis at 12 months [Time frame: Baseline and 12 months.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Colorado — Aurora

Identifiers

NCT: NCT05005793 · 21-3447 · R01DK130255

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗