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

NCT05005793 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-29

No results posted yet for this study

Summary

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

  • Metabolic Acidosis
  • Kidney Transplant; Complications
  • Vascular Diseases

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

Sponsors & Collaborators

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

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05005793 on ClinicalTrials.gov