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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Renal Insufficiency, Chronic
• Intervention / Treatment: Drug: Dialysis Solutions

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm	Drug: Dialysis Solutions; Solution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum CRP (C-reactive protein)	Change in serum CRP during the 3 months of citrate-buffered dialysis	Months 4th to 6th

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2014
• Primary Completion (Actual): July 30, 2015
• Study Completion (Actual): July 30, 2015

Study Registration Dates

• First Submitted: June 13, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Inflammation; Renal Insufficiency; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: 0064476; 2CEI-753 (Other Identifier: IRB from AO Citta Della Salute e Della Scienza di Torino)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No