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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 29, 2025 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. 3 versions Re-verified since Apr 18, 2023, no change to tracked fieldsv3-v5
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 1, 2021 to Dec 1, 2021 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date changed from estimate of Sep 1, 2021 to Dec 1, 2021
    • Study sites: 0 to 1
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05005793
Lead Sponsor University of Colorado, Denver
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Metabolic Acidosis, Kidney Transplant; Complications, Vascular Diseases
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov