Chronic Kidney DiseasePhase 2NCT04020757
H+ Mobilization With Dialysate Bicarbonate Variation
A Phase 2 study testing variation in dialysis bicarbonate and Zone Perfect bar in people with Chronic Kidney Disease, run by Tufts Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- variation in dialysis bicarbonate and Zone Perfect bar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 30 Nov 2019
- Phase
- Phase 2
- 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
- Patients must be 18 years or older,
- Have been on dialysis for at least 1 year,
- Be stable on treatment (i.e., without frequent changes in their dialysis prescription, or recent hospitalizations),
- Be reasonably nourished (serum albumin > 3.5 g/dl and not currently receiving oral nutritional supplement through DCI).
- Self-reported urine output of <200 cc/day
- Functioning arteriovenous fistulas or grafts for dialysis access
- Currently dialyzing at a dialysate [HCO3-] of 33-37 mEq/L.
Who cannot join
- Pregnancy,
- Acute illnesses of any kind,
- Hospitalization in the prior 3 months (except for vascular access related),
- Significant congestive heart failure, liver or lung failure.
- Pre-dialysis blood [HCO3-] <19 mEq/L) (to reduce the risk of metabolic acidosis )
Trial locations and contacts
1 site in 1 country.
About this study
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-].
- Conditions
- Chronic Kidney Disease
- Being tested
- variation in dialysis bicarbonate, Zone Perfect bar
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
variation in dialysis bicarbonateDevice
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
Zone Perfect barDietary supplement
16g protein supplement given during first 30 mins of dialysis on last testing day
| Study group | Role | What they receive |
|---|---|---|
| Bicarb Variation | Other | Variation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3 Receives: Device: variation in dialysis bicarbonate; Dietary Supplement: Zone Perfect bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate levels
7 tests conducted through the dialysis treatment after the long interdialytic interval
Measured: through study completion, a period of 3 weeks
H+ mobilization
7 tests conducted through the dialysis treatment after the long interdialytic interval
Measured: through study completion, a period of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start12 Jun 2019
- Primary completion30 Oct 2019
- Study completion30 Nov 2019
Why it stopped: Biochemical measurement techniques were deemed insufficient to continue research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020757
- Sponsor's protocol ID
- 13296
- Status last verified
- Mar 2020
- First submitted
- 4 Jun 2019
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H+ Mobilization With Dialysate Bicarbonate Variation
- ClinicalTrials.gov ID
- NCT04020757
- Acronym / sponsor ID
- 13296
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Biochemical measurement techniques were deemed insufficient to continue research
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Dialysis Clinic, Inc.
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 16 Jul 2019 (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.
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-].
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bicarb Variation | Other | Device: variation in dialysis bicarbonate, Dietary Supplement: Zone Perfect barVariation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be 18 years or older,
- Have been on dialysis for at least 1 year,
- Be stable on treatment (i.e., without frequent changes in their dialysis prescription, or recent hospitalizations),
- Be reasonably nourished (serum albumin > 3.5 g/dl and not currently receiving oral nutritional supplement through DCI).
- Self-reported urine output of <200 cc/day
Key exclusion criteria (5 listed)
- Pregnancy,
- Acute illnesses of any kind,
- Hospitalization in the prior 3 months (except for vascular access related),
- Significant congestive heart failure, liver or lung failure.
- Pre-dialysis blood [HCO3-] <19 mEq/L) (to reduce the risk of metabolic acidosis )
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 |
|---|---|---|
| variation in dialysis bicarbonate35 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 | Device | Bicarb Variation |
| Zone Perfect bar16g protein supplement given during first 30 mins of dialysis on last testing day | Dietary supplement | Bicarb Variation |
Primary outcome
Lactate levels
Time frame: through study completion, a period of 3 weeks
7 tests conducted through the dialysis treatment after the long interdialytic interval
H+ mobilization
Time frame: through study completion, a period of 3 weeks
7 tests conducted through the dialysis treatment after the long interdialytic interval
Results and safety
The study was stopped early (reason given: Biochemical measurement techniques were deemed insufficient to continue research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing variation in dialysis bicarbonate and Zone Perfect bar in people with Chronic Kidney Disease, run by Tufts Medical Center 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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 12 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Biochemical measurement techniques were deemed insufficient to continue research). Results are not available in the source record.
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?
Lactate levels (time frame: through study completion, a period of 3 weeks). The study lists 2 primary outcomes in all. 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 12 Mar 2020.