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

Who is this study for? Patients with Vascular Diseases, Kidney Transplant Complications, Metabolic Acidosis
What treatments are being studied? Sodium Bicarbonate
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
United States
Colorado
University of Colorado
RECRUITING
Aurora
Contact Information
Primary
Jessica Kendrick, MD MPH
jessica.kendrick@ucdenver.edu
3037244837
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 120
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov