NCT03428464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

December 5, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1.3 years

First QC Date

January 29, 2018

Last Update Submit

October 19, 2020

Conditions

Kidney Transplant; ComplicationsMetabolic Acidosis

Outcome Measures

Primary Outcomes (1)

  • Change in Brachial Artery Flow-Mediated Dilation

    Brachial artery Flow-Mediated Dilation (FMD) will be determined using high-resolution ultrasonography (Toshiba Xario 200) as described originally by Celermajer et al., and more recently by our group. FMD will be measured at the beginning and end of each study period for a total of 4 measurements. ECG-gated end-diastolic ultrasound images and Doppler flow of the brachial artery will be acquired during baseline and FMD conditions.

    Baseline, 8, 10, and 18 weeks

Secondary Outcomes (2)

  • Change in Transforming Growth Factor Beta 1 (TGF-B1)

    Baseline, 8, 10, and 18 weeks

  • Change in Cognitive Function

    Baseline, 8, 10, and 18 weeks

Study Arms (2)

Sodium bicarbonate

EXPERIMENTAL

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

Drug: Sodium Bicarbonate

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Sodium BicarbonateDRUG

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

Also known as: Baking soda
Sodium bicarbonate
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Acidosis

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Jessica Kendrick, MD MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 9, 2018

Study Start

December 5, 2018

Primary Completion

March 25, 2020

Study Completion

March 25, 2020

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

US(1)