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

Primary Purpose

Renal Insufficiency, Chronic, Inflammation

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Dialysis Solutions

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Outcomes

Primary Outcome Measures

Change in serum CRP (C-reactive protein)

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

Secondary Outcome Measures

Change in dialysis efficiency

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

Change in serum CRP (C-reactive protein)

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

Full Information

NCT ID

NCT03577249

First Posted

June 13, 2018

Last Updated

July 6, 2018

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

1. Study Identification

Unique Protocol Identification Number

NCT03577249

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

October 30, 2014 (Actual)

Primary Completion Date

July 30, 2015 (Actual)

Study Completion Date

July 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency, Chronic, Inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Sequential Assignment

Model Description

45 patients with end stage renal disease will be treated with dialysis solution A (standard of care: acetate-buffered) for 3 months then with solution B (acetate-free, citrate buffered, otherwise identical to solution A) for 3 months and then with solution A for the final 3 months

Masking

None (Open Label)

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Dialysis Solutions

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in serum CRP (C-reactive protein)

Description

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

Time Frame

Months 4th to 6th

Secondary Outcome Measure Information:

Title

Change in dialysis efficiency

Description

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)

Title

Change in serum CRP (C-reactive protein)

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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