Last reviewed · How we verify
NCT03315624: eMPORA
Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane
NA trial testing Dialyzer in Renal Failure in 49 participants. Completed in 14 March 2018.
9 December 2017
Quick facts
| Lead sponsor | Fresenius Medical Care Deutschland GmbH |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 6 October 2017 |
| Primary completion | 9 December 2017 |
| Estimated completion | 14 March 2018 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Dialyzer
Conditions studied
- Renal Failure — all drugs for Renal Failure →
- End Stage Renal Disease — all drugs for End Stage Renal Disease →
Sponsor
Fresenius Medical Care Deutschland GmbH — full company profile →
Who can join
18 and older, any sex, with Renal Failure or End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone membrane to obtain CE-certification according to the European Medical Device Directive for the FX Coral 600 (TD 16-1) dialyzer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03315624
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dialyzer
Trials testing the same drug.
- NCT03611218 — Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration · NA · completed
Other recruiting trials for Renal Failure
Currently open trials in the same condition.
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- NCT06142396 — Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure · EARLY_PHASE1 · recruiting
- NCT06620523 — Prevent Cardiac Surgery Associated AKI Trial · Phase 2 · recruiting
Other Fresenius Medical Care Deutschland GmbH trials
Trials by the same sponsor.
- NCT06236984 — Retrospective Data Analysis of CKRT (Continuous Kidney Replacement Therapy) Treatments in Adult Mode With multiFiltrateP · completed
- NCT05441020 — Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis · completed
- NCT05315817 — Safety and Performance Evaluation of multiPlus Dialysate During CRRT · NA · terminated
- NCT05142501 — Observation of the Immune Response After COVID-19 Additional Vaccine Doses in Chronic Patients in Hemodialysis Therapy · terminated
- NCT04871893 — Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration · NA · 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 NCT03315624 (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 Fresenius Medical Care Deutschland GmbH
- Last refreshed: 29 March 2018
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/NCT03315624.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing