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NCT04020757
H+ Mobilization With Dialysate Bicarbonate Variation
Phase 2 trial testing variation in dialysis bicarbonate in Chronic Kidney Disease in 13 participants. Terminated before completion.
30 October 2019
Quick facts
| Lead sponsor | Tufts Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 12 June 2019 |
| Primary completion | 30 October 2019 |
| Estimated completion | 30 November 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- variation in dialysis bicarbonate
- Zone Perfect bar
Conditions studied
- Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
Sponsor
Tufts Medical Center
Who can join
18 and older, any sex, with Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 \[HCO3-\].
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04020757
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04020757 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tufts Medical Center
- Last refreshed: 12 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04020757.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing