Kidney Transplant; ComplicationsNCT03428464
Bicarbonate Administration in Kidney Transplant Recipients
A study testing Sodium Bicarbonate in people with Kidney Transplant; Complications and Metabolic Acidosis, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Metabolic Acidosis
- What is being tested?
- Sodium Bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 25 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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.
- Being tested
- Sodium Bicarbonate, Placebo
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium BicarbonateDrug
Also called Baking soda
Participants will take ½ the daily dose of sodium bicarbonate in the morning and the other ½ in the evening.
PlaceboOther
Participants will take ½ the daily dose of a placebo in the morning and the other ½ in the evening.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8, 10, and 18 weeks
Secondary outcomes (2)
Change in Transforming Growth Factor Beta 1 (TGF-B1)
Urinary TGF-B1 will be measured from 24-hour urine collections. It will be measured by a commercially available ELISA (R\&D Systems). The within day precision for this assay is 6.7% at 257 pg/ml. All measurements will be performed at the Children's Pediatric CTRC at Children's Hospital Colorado.
Measured: Baseline, 8, 10, and 18 weeks
Change in Cognitive Function
Cognitive function will be assessed using the National Institutes of Health (NIH) Toolbox computerized tests to evaluate 1) attention, 2) episodic memory, 3) working memory, 4) language, 5) executive function, and 6) processing speed.
Measured: Baseline, 8, 10, and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start5 Dec 2018
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Kendrick, MD MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428464
- Sponsor's protocol ID
- 17-2317
- Status last verified
- Oct 2020
- First submitted
- 29 Jan 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bicarbonate Administration in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT03428464
- Acronym / sponsor ID
- 17-2317
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Experimental | Drug: Sodium BicarbonateDuring the treatment period, participants will receive 0.5 mEq/kg-lean body weight (LBW)/day of oral sodium bicarbonate for 8 weeks. |
| Placebo | Placebo comparator | Other: PlaceboDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium BicarbonateAlso: Baking sodaParticipants will take ½ the daily dose of sodium bicarbonate in the morning and the other ½ in the evening. | Drug | Sodium bicarbonate |
| PlaceboParticipants will take ½ the daily dose of a placebo in the morning and the other ½ in the evening. | Other | Placebo |
Primary outcome
Change in Brachial Artery Flow-Mediated Dilation
Time frame: Baseline, 8, 10, and 18 weeks
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.
2 secondary outcomes
Change in Transforming Growth Factor Beta 1 (TGF-B1)
Time frame: Baseline, 8, 10, and 18 weeks
Change in Cognitive Function
Time frame: Baseline, 8, 10, and 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Kendrick, MD MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Bicarbonate in people with Kidney Transplant; Complications and Metabolic Acidosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brachial Artery Flow-Mediated Dilation (time frame: Baseline, 8, 10, and 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.