Updated Design and Status of CONTINUITY: A Phase 4 Study of Continued Postdischarge Sodium Zirconium Cyclosilicate in CKD
Bibliographic record
Abstract
Background: Patients (pts) hospitalized with hyperkalemia (HK) have increased risk of recurrent HK and re-hospitalization. The ongoing CONTINUITY study (NCT05347693) compares efficacy of continued post-discharge sodium zirconium cyclosilicate (SZC) treatment vs standard of care (SoC) in hospitalized pts with chronic kidney disease (CKD) and HK. We present protocol changes made to clarify eligibility criteria, better align inclusion/exclusion criteria with local practice, and ensure a more clinically relevant main secondary endpoint (Figure). Methods: CONTINUITY is a randomized, open-label study across 6 European countries. Pts with CKD admitted to hospital with HK will be treated in hospital with SZC. At discharge, pts with normokalemia (NK; serum potassium [sK+] 3.5–5.0 mmol/L) are randomized 1:1 to SZC:SoC, per local label/practice, for 180 days. The primary endpoint evaluates SZC efficacy as part of discharge medications, vs SoC, in maintaining NK. The main secondary endpoint evaluates the effect of SZC as part of discharge medications, vs SoC, in reducing incidence of the composite outcome of all-cause hospital admissions, or emergency department visits with HK as a contributing factor, or all-cause death, or use of rescue-therapy for HK. Results: As of May 2024, 179 pts were enrolled and 129 randomized (SZC n=65; SoC n=64) from Belgium (n=2), France (n=6), Italy (n=9), the Netherlands (n=1), Spain (n=109), and the UK (n=2); mean age 72 years, 29% female. Further baseline demographics/characteristics will be presented at Kidney Week 2024. Conclusion: The CONTINUITY study (estimated completion: Dec 2024) will provide important evidence supporting either SoC or more active sK+ management with a K+ binder post discharge for pts with CKD admitted with HK. Protocol changes allow inclusion of a wider pt population and the potential to improve the clinical relevance of the results. Funding: Commercial Support - AstraZeneca
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".