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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sodium bicarbonate
  • Placebo

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator