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NCT04020757 · ClinicalTrials.gov registry record · Phase 2
H+ Mobilization With Dialysate Bicarbonate Variation
A Phase 2 study, sponsored by Tufts Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT04020757: Clinical Trial Phase 2 study, sponsored by Tufts Medical Center.
NCT04020757 is a Phase 2 study that was terminated before completion, run by Tufts Medical Center. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04020757, a Phase 2 study, was terminated before completion, sponsored by Tufts Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The aims of the proposed studies are first to delineate the physiological response of End Stage Kidney Disease (ESKD) patients to exposure to a bath \[HCO3-\] of 35 mEq/L and an \[acetate\] of 4 mEq/L, and second, to determine whether reducing bath \[HCO3-\] will have the expected effect of decreasing or abolishing stimulation of organic acid production. A secondary endpoint will be whether the patients tolerate such a reduction and its impact on pre-dialysis blood \[HCO3-\]. If the outcome is positive in both regards, future studies will measure well-being and outcomes with reduced bath \[HCO3-\].
Primary Outcome
7 tests conducted through the dialysis treatment after the long interdialytic interval
Interventions
- DEVICE variation in dialysis bicarbonate
- DIETARY_SUPPLEMENT Zone Perfect bar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2019-11-30 |
| Phase | Phase 2 |
Why NCT04020757 stopped before completion
NCT04020757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which variation in dialysis bicarbonate is the first listed.
NCT04020757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04020757 about?
NCT04020757 is a clinical study titled "H+ Mobilization With Dialysate Bicarbonate Variation". The aims of the proposed studies are first to delineate the physiological response of End Stage Kidney Disease (ESKD) patients to exposure to a bath \[HCO3-\] of 35 mEq/L and an \[acetate\] of 4 mEq/L, and second, to determine whether reducing bath \[HCO3-\] will have the expected effect of decreasi...
What is the current status of trial NCT04020757?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2019-06-12. Estimated completion is 2019-11-30.
What interventions are being tested in trial NCT04020757?
The interventions under investigation include: variation in dialysis bicarbonate (DEVICE), Zone Perfect bar (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04020757?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04020757's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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