Bicarbonate Administration in Kidney Transplant Recipients

NCT ID: NCT03428464

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2020-03-25

Brief Summary

Metabolic acidosis is associated with vascular endothelial dysfunction and is a common complication in patients who have received a kidney transplant. Kidney transplant recipients (KTR) with lower serum bicarbonate levels, even within the normal range, have an increased risk of graft loss and mortality. The investigators propose a prospective, double-blind, randomized, placebo-controlled, 18-week crossover pilot study to examine the effects of sodium bicarbonate on vascular endothelial function, graft function, and cognitive function in 20 KTR patients.

Conditions

Kidney Transplant; Complications; Metabolic Acidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sodium bicarbonate

During the treatment period, participants will receive 0.5 mEq/kg-lean body weight (LBW)/day of oral sodium bicarbonate for 8 weeks.

Group Type: EXPERIMENTAL

Sodium Bicarbonate

Intervention Type: DRUG

Participants will take ½ the daily dose of sodium bicarbonate in the morning and the other ½ in the evening.

Placebo

During the control period, participants will take the same number of placebo capsules as if they were assigned 0.5 mEq/kg-LBW/day of sodium bicarbonate.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will take ½ the daily dose of a placebo in the morning and the other ½ in the evening.

Interventions

Sodium Bicarbonate

Participants will take ½ the daily dose of sodium bicarbonate in the morning and the other ½ in the evening.

Intervention Type: DRUG

Placebo

Participants will take ½ the daily dose of a placebo in the morning and the other ½ in the evening.

Intervention Type: OTHER

Other Intervention Names

Baking soda

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Kidney transplant received at least 1 year ago
• Serum bicarbonate 20-26 mEq/L on 2 separate measurements (at least 1 day apart)
• eGFR >45 ml/min/1.73m2
• Blood pressure <140/90 mm Hg prior to randomization
• BMI < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
• Able to provide consent
• Stable kidney transplant medication regimen for at least 1 month 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 · 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Kendrick, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Other Identifiers

17-2317

Identifier Type: -

Identifier Source: org_study_id