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NCT04955678
A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia
Phase 3 trial testing Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes in Hyperkalemia in 85 participants. Completed in 13 March 2023.
26 December 2022
Quick facts
| Lead sponsor | Zeria Pharmaceutical |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 85 |
| Start date | 3 August 2021 |
| Primary completion | 26 December 2022 |
| Estimated completion | 13 March 2023 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes
- Placebo
Conditions studied
- Hyperkalemia — all drugs for Hyperkalemia →
Sponsor
Zeria Pharmaceutical — full company profile →
Who can join
Adults 20 to 80, any sex, with Hyperkalemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the superiority of ZG-801 to placebo in Japanese hyperkalemia patients whose serum potassium value becomes normal in the Run-in period by comparing the change in the value at the Double-blind period week 4, and to further evaluate the efficacy and safety of ZG-801 in Japanese hyperkalemia patients administrated ZG-801 for maximum 9 weeks.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy and safety of patiromer for hyperkalemia: a randomized, placebo-controlled phase 3 study.
Kashihara N, Okada H, Suzuki Y, Iwamoto T, et al · · 2025 · cited 2× · PMID 39976633 · DOI 10.1007/s10157-025-02637-4
Verify or expand the search:
- PubMed search for NCT04955678
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hyperkalemia
Currently open trials in the same condition.
- NCT06366230 — Adding Urea to the Final Dialysis Fluid · Phase 1, PHASE2 · recruiting
- NCT06884267 — Hyperkalemia Quality Improvement Program (HK-QIP) Study · NA · recruiting
- NCT06940414 — Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community · recruiting
- NCT05766839 — Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age · Phase 2 · recruiting
- NCT06365684 — Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4 · Phase 4 · recruiting
Other Zeria Pharmaceutical trials
Trials by the same sponsor.
- NCT03799926 — Exploratory Study of ZG-801 for the Treatment of Hyperkalemia · Phase 2 · completed
- NCT03476018 — Trial to Optimally Show the Pharmacological Action of Z-100 · Phase 3 · completed
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 NCT04955678 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zeria Pharmaceutical
- Last refreshed: 20 April 2023
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/NCT04955678.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing