18 and older, any sex, with End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Subjects With Safety EventPrimary· 52 weeks
The Total Number of subjects having at least one Anticipated AE, Unanticipated AE, Device Related AE, Anticipated SAE, Unanticipated SAE and Device Related SAEs.
Anticipated Adverse Event
Group
Value
95% CI
The HemoCare™ Hemodialysis System
20
Unanticipated Adverse Event
Group
Value
95% CI
The HemoCare™ Hemodialysis System
20
Device-Related Adverse Event
Group
Value
95% CI
The HemoCare™ Hemodialysis System
5
Anticipated Serious Adverse Event
Group
Value
95% CI
The HemoCare™ Hemodialysis System
6
Unanticipated Serious Adverse Event
Group
Value
95% CI
The HemoCare™ Hemodialysis System
12
Device Related Serious Adverse Event
Group
Value
95% CI
The HemoCare™ Hemodialysis System
0
Adverse events — posted to ClinicalTrials.gov
Time frame: During study participation - from the time of consent until the end of participation (on average 1 year).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is designed to monitor and assess the safety of continued access to the HemoCare™ Hemodialysis System used during the review of the pre-market notifications for the devices in the HemoCare™ Hemodialysis System.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Deka Research and Development
Last refreshed: 8 September 2025
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/NCT04198012.