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RECRUITING
NCT05005793
PHASE4

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

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-12-01

Completion Date

2026-08-31

Last Updated

2025-05-29

Healthy Volunteers

No

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

Locations (1)

University of Colorado

Aurora, Colorado, United States