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NCT04997161 · ClinicalTrials.gov registry record · Phase 4
Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia
A Phase 4 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT04997161: Clinical Trial Phase 4 study, sponsored by AstraZeneca.
NCT04997161 is a Phase 4 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04997161, a Phase 4 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
Prescribing Sodium zirconium cyclosilicate (SZC) with enhanced nutritional advice to participants with hyperkalaemia on haemodialysis will reduce serum K+ (S-K+ ) and enable the consumption of more fruit and vegetables and more satisfying diet. The study aims to show that participants using SZC achieve S-K+ reduction as well as participants on SoC (other than K+ binders), without the need for restricting K+ in the diet.
Primary Outcome
Change in serum potassium taken at long interdialytic-dialysis interval visits Month 3, Month 4, and Month 5 compared to baseline
Interventions
- DRUG Sodium Zirconium Cyclosilicate (SZC)
- OTHER Enhanced dietary advice
- OTHER Standard dietary advice including K+ restriction.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-08-17 |
| Est. Completion | 2021-11-17 |
| Phase | Phase 4 |
Why NCT04997161 stopped before completion
NCT04997161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Sodium Zirconium Cyclosilicate (SZC) is the first listed.
NCT04997161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04997161 about?
NCT04997161 is a clinical study titled "Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia". Prescribing Sodium zirconium cyclosilicate (SZC) with enhanced nutritional advice to participants with hyperkalaemia on haemodialysis will reduce serum K+ (S-K+ ) and enable the consumption of more fruit and vegetables and more satisfying diet. The study aims to show that participants using SZC achi...
What is the current status of trial NCT04997161?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2021-08-17. Estimated completion is 2021-11-17.
What interventions are being tested in trial NCT04997161?
The interventions under investigation include: Sodium Zirconium Cyclosilicate (SZC) (DRUG), Enhanced dietary advice (OTHER), Standard dietary advice including K+ restriction. (OTHER).
Who is sponsoring clinical trial NCT04997161?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04997161's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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