NCT05005793

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-12-01
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2021-08-16
• Last updated: 2025-05-29

Locations

1 site across 1 country: United States