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NCT02863016: HEPHAESTUS
tHe Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers in TUscan Prevalent Hemodialysis patientS: HEPHAESTUS Study
trial testing SelectBag One in ESRD in 66 participants. Completed in 1 April 2017.
1 August 2016
Quick facts
| Lead sponsor | Ospedale Santa Maria Annunziata |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 66 |
| Start date | 1 July 2016 |
| Primary completion | 1 August 2016 |
| Estimated completion | 1 April 2017 |
| Sites | 3 locations across Italy |
Drugs / interventions tested
- SelectBag One
Conditions studied
- ESRD — all drugs for ESRD →
Sponsor
Ospedale Santa Maria Annunziata
Who can join
18 and older, any sex, with ESRD. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Inflammation
Time frame: 3 months
Value of IL-6
Sponsor's own description
The aim of this study was to evaluate the effect and timing of action on the inflammatory state of a acetate-free containing citrate concentrate (Cit-, 1 mM Citrate) in online postidultion HDF with high volumes compared to traditional concentrated (Ac-, 3 mM of acetate ) in the medium term. In addition, the study will evaluate other parameters of efficiency dialysis, cardiovascular stability, the safety of the concentrate with regard to bone metabolism and vessel calcification in the medium term.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Citrate high volume on-line hemodiafiltration modulates serum Interleukin-6 and Klotho levels: the multicenter randomized controlled study "Hephaestus".
Pizzarelli F, Cantaluppi V, Panichi V, Toccafondi A, et al · · 2021 · cited 14× · PMID 33559851 · DOI 10.1007/s40620-020-00943-6
Verify or expand the search:
- PubMed search for NCT02863016
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for ESRD
Currently open trials in the same condition.
- NCT06913647 — Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis · Phase 2 · recruiting
- NCT06366230 — Adding Urea to the Final Dialysis Fluid · Phase 1, PHASE2 · recruiting
- NCT05339139 — SAfety of Regional Citrate Anticoagulation (SARCA Study) · Phase 3 · recruiting
- NCT05434325 — TESTING -ON Post-Trial ObservatioNal Cohort Study · recruiting
- NCT05309785 — Safety and Efficacy of Canagliflozin in Advanced CKD · Phase 4 · active not recruiting
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 NCT02863016 (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 Ospedale Santa Maria Annunziata
- Last refreshed: 16 December 2020
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/NCT02863016.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing