Alkali therapy for improving kidney transplant outcomes
Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant
This study is testing if sodium bicarbonate therapy can help improve kidney function and heart health in kidney transplant recipients who have low bicarbonate levels.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05005793 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of sodium bicarbonate therapy on vascular and graft function in kidney transplant recipients (KTRs) who have low serum bicarbonate levels. Conducted as a randomized, double-blinded, placebo-controlled trial, it will enroll 120 KTRs and assess the impact of bicarbonate treatment over 12 months. The hypothesis is that alkali therapy may enhance graft function and reduce cardiovascular risks by decreasing complement activation. Participants will be closely monitored for changes in surrogate markers of cardiovascular disease and graft health.
Who should consider this trial
Good fit: Ideal candidates are kidney transplant recipients aged 18-80 with specific serum bicarbonate levels and stable immunosuppression regimens.
Not a fit: Patients with significant comorbid conditions that limit life expectancy or those not meeting the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the health and longevity of kidney grafts and reduce cardiovascular complications in transplant recipients.
How similar studies have performed: While the approach of using alkali therapy in this context is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Jessica Kendrick, MD MPH — University of Colorado Denver | Anschutz
- Study coordinator: Jessica Kendrick, MD MPH
- Email: jessica.kendrick@ucdenver.edu
- Phone: 3037244837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.