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NCT03577249

Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation

Completed Phase 2, PHASE3 Last updated 9 July 2018
What this trial tests

Phase 2, PHASE3 trial testing Dialysis Solutions in Renal Insufficiency, Chronic in 45 participants. Completed in 30 July 2015.

Timeline
30 October 2014
Primary endpoint
30 July 2015
30 July 2015

Quick facts

Lead sponsorA.O.U. Città della Salute e della Scienza
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Designsequential
Maskingnone
Primary purposetreatment
Enrollment45
Start date30 October 2014
Primary completion30 July 2015
Estimated completion30 July 2015
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

A.O.U. Città della Salute e della Scienza — full company profile →

Who can join

18 and older, any sex, with Renal Insufficiency, Chronic or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study 45 patients undergoing weekly dialysis for chronic end stage renal disease will be enrolled. The patients will be treated with a standard dialysis solution, containing acetate buffer, for 3 months; subsequently the acetate will be substituted with citrate anion for the 3 following months and then, the last 3 months, the standard acetate-solution will be restarted. The aim of the study is to assess if acetate-to-citrate switch in the dialysis solution influences dialysis efficiency and patient inflammatory state.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Citrate anion improves chronic dialysis efficacy, reduces systemic inflammation and prevents Chemerin-mediated microvascular injury.
    Dellepiane S, Medica D, Guarena C, Musso T, et al · · 2019 · cited 26× · PMID 31337804 · DOI 10.1038/s41598-019-47040-8

Verify or expand the search:

Other recruiting trials for Renal Insufficiency, Chronic

Currently open trials in the same condition.

Other A.O.U. Città della Salute e della Scienza trials

Trials by the same sponsor.

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Data sources for this page

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