Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
Recruiting
Phase 4
Interventional Study
Metabolic Acidosis
Kidney Transplant; Complications
Vascular Diseases
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- University of Colorado, Denver · Other
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About This Trial
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-bli…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 18-80 years
* Serum bicarbonate 16-24 mEq/L on 2 separate measurements (at least 1 day apart)
* Kidney transplant received 1 year prior to randomization
* eGFR ≥ 45 ml/min/1.73m2 by CKD-EPI equation
* Blood pressure \<130/80 mm Hg prior to randomization
* BMI \< 40 kg/m2 (…
Contacts