NCT05005793 Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
| NCT ID | NCT05005793 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Colorado, Denver |
| Condition | Metabolic Acidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2021-12-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 (FMD measurements can be inaccurate in severely obese patients). * Able to provide consent * Immunosuppression regimen consisting of tacrolimus, mycophenolate mofetil and prednisone (95% of patients at University of Colorado are on this regimen) * Stable immunosuppression regimen for at least three months prior to randomization * Stable anti-hypertensive regimen for at least one month prior to randomization * Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin). Exclusion Criteria: * Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year * Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda) * Uncontrolled hypertension * Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening * New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months * Nephrotic range proteinuria (urine complement activation fragment measurements may not be accurate with severe proteinuria) * Factors judged to limit adherence to interventions * Current participation in another research study * Pregnancy or planning to become pregnant or currently breastfeeding * Chronic use of supplemental oxygen * Use of anticoagulants
Contact & Investigator
Jessica Kendrick, MD MPH
PRINCIPAL INVESTIGATOR
University of Colorado Denver | Anschutz
Frequently Asked Questions
Who can join the NCT05005793 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Metabolic Acidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05005793 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05005793 currently recruiting?
Yes, NCT05005793 is actively recruiting participants. Contact the research team at jessica.kendrick@ucdenver.edu for enrollment information.
Where is the NCT05005793 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05005793 clinical trial?
NCT05005793 is sponsored by University of Colorado, Denver. The principal investigator is Jessica Kendrick, MD MPH at University of Colorado Denver | Anschutz. The trial plans to enroll 120 participants.