An interventional study of Sodium Bicarbonate and Placebo in Kidney Transplant; Complications and Metabolic Acidosis, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
Among 17 studies testing Sodium Bicarbonate in Acidosis — 4 open to participants now, 5 under way, 1 of them phase 3. Sodium Bicarbonate · Acidosis.
Among the 17 studies testing Sodium Bicarbonate in Acidosis, this one is the 14th largest by enrollment, is one of 2 that started in 2018, is one of 6 with no phase, and was the 9th registered.
111 studies on the registry are indexed under Acidosis; 19 are open to participants now.
Browse Acidosis studies →4 of the 17 studies testing Sodium Bicarbonate in Acidosis are open now, in 3 countries. Recruiting first, the newest first:
Universität Münster · Sites in Germany
Ages 18+
University of California, Davis · Sites in United States
Ages 21–85
University of Colorado, Denver · Sites in United States
Ages 18–80
University of Sfax · Sites in Tunisia
Ages 18+
By country, each count listing its studies:
Sodium Bicarbonate: first FDA approval 1981 (BSS PLUS). What it is approved for, and how studies give it, is on its page →
Of the 17 Acidosis studies recruiting now, 13 (76%) set no upper age limit and 2 (12%) stop at 75 or younger; 5 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 4 · Phase 3 4 · Phase 4 2
First in 2009; this study’s year is marked. 2 started in 2018.
This study's enrollment of 20 is below the median of 52 across 79 interventional studies indexed under Acidosis.
Median enrollment 50 across the 17 interventional studies. Of the 11 that completed or were terminated, 6 (55%) have results posted.
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None of the 17 has an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 5 studies filed under Acidosis — fewer than ten, so there is no comparison to draw.
1 of the studies testing Sodium Bicarbonate in Acidosis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04984226University of California, DavisSodium Bicarbonate and Mitochondrial Energetics in Persons With CKD | 2026-12-31 |
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Among the 17 studies testing Sodium Bicarbonate in Acidosis, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Participants will take ½ the daily dose of a placebo in the morning and the other ½ in the evening.
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.
Time frame: Baseline, 8, 10, and 18 weeks
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.
Time frame: 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.
Time frame: Baseline, 8, 10, and 18 weeks
Ran from Dec 2018 to primary completion in Mar 2020, 15 months.
Of 20 interventional studies with no phase under Acidosis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 50. This study's 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Bicarbonate
University of Colorado, Denver →