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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05005793
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Kidney Transplant; Complications
  • Metabolic Acidosis
  • Vascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 1, 2021
Status verified
May 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sodium bicarbonate
    Oral sodium bicarbonate at a dose of 0.5 mEq/kg-lean body weight/day
  • Placebo Comparator: Placebo
    Oral placebo at a dose of 0.5 mEq/kg-lean body weight/day

Primary Outcome Measure

Change in Brachial artery flow mediated dilation at 12 months [ Time Frame: Baseline and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045
Jessica Kendrick
[email protected]
303-724-4837

Find similar trials in Aurora, CO

By research site
University of Colorado· Aurora, CO

Related Studies