A Phase 2 interventional study of variation in dialysis bicarbonate and Zone Perfect bar in Chronic Kidney Disease, sponsored by Tufts Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-12.
Sponsored by Tufts Medical Center · Phase 2, Interventional, and Treatment
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-].
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 13 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Variation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3
Device: variation in dialysis bicarbonate · Dietary Supplement: Zone Perfect bar
35 mEq/L dialysate bicarbonate for one week, followed by 30 mEq/L for one week, followed by 35mEq/L for one week with nutritional supplement during dialysis
16g protein supplement given during first 30 mins of dialysis on last testing day
Lactate levels
7 tests conducted through the dialysis treatment after the long interdialytic interval
Time frame: through study completion, a period of 3 weeks
H+ mobilization
7 tests conducted through the dialysis treatment after the long interdialytic interval
Time frame: through study completion, a period of 3 weeks
This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tufts Medical Center