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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03577249
Other study ID # 0064476
Secondary ID 2CEI-753
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date October 30, 2014
Est. completion date July 30, 2015

Study information

Verified date July 2018
Source Azienda Ospedaliera Città della Salute e della Scienza di Torino
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date July 30, 2015
Est. primary completion date July 30, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

- known neoplastic disease

- active chronic inflammatory disease

- active acute inflammatory disease

Study Design


Intervention

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

Locations

Country Name City State
Italy Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette Torino To

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in serum CRP (C-reactive protein) Change in serum CRP during the 3 months of citrate-buffered dialysis Months 4th to 6th
Secondary Change in dialysis efficiency Dougirdas formula will be used to estimate dialysis efficiency at the beginning and completion of each study interval Every 3 months (month 0, 6, 3 and completion - 9)
Secondary Change in serum CRP (C-reactive protein) Variation of serum CRP at the beginning and completion of each study interval Every 3 months (month 0, 6, 3 and completion - 9)
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