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CompletedNCT03577249Updated Jul 9, 2018

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

A Phase 2/3 interventional study of Dialysis Solutions in Renal Insufficiency, Chronic and Inflammation, sponsored by A.O.U. Città della Salute e della Scienza. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-09.

Sponsored by A.O.U. Città della Salute e della Scienza · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Oct 2014, registered Jun 2018).
Phase
Phase 2/3
Study type
Interventional
Enrollment
45
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Renal Insufficiency, Chronic
  • Inflammation
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 45 is close to the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

A.O.U. Città della Salute e della Scienza is the lead sponsor of 63 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age >18 years
  • creatinine clearance \<5ml/min
  • treatment with bicarbonate HD (BIC-HD) or on-line hemodiafiltration (OL-HDF) 3 times per week for at least 6 months prior to study start
  • treated at Dialysis unit of: Città della Salute e della Scienza University Hospital, Torino, Italy

Exclusion criteria

Exclusion Criteria:

  • known neoplastic disease
  • active chronic inflammatory disease
  • active acute inflammatory disease
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Single arm

    Drug: Dialysis Solutions

Interventions

  • DrugDialysis Solutions

    Solution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion

06

What researchers measure

Primary outcomes

  1. Change in serum CRP (C-reactive protein)

    Change in serum CRP during the 3 months of citrate-buffered dialysis

    Time frame: Months 4th to 6th

Secondary outcomes

  1. Change in dialysis efficiency

    Dougirdas formula will be used to estimate dialysis efficiency at the beginning and completion of each study interval

    Time frame: Every 3 months (month 0, 6, 3 and completion - 9)

  2. Change in serum CRP (C-reactive protein)

    Variation of serum CRP at the beginning and completion of each study interval

    Time frame: Every 3 months (month 0, 6, 3 and completion - 9)

07

Study locations

1 site
  • Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette
    Torino, To 10126, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03577249
Lead sponsor
A.O.U. Città della Salute e della Scienza
Responsible party
Vincenzo Cantaluppi (Associate professor of Nephrology, A.O.U. Città della Salute e della Scienza) — Principal investigator
First posted
Jul 5, 2018
Start date
Oct 30, 2014
Primary completion
Jul 30, 2015
Completion
Jul 30, 2015
Last update
Jul 9, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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