Biological Effects of Citrate-buffered Solutions on Dialy... | NCT03577249

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

NCT03577249

Sponsor

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

Status

Completed

Last Update Posted

Jul 9, 2018Actual

Enrollment

45Actual

Phase

Phase 2Phase 3

Conditions

Renal Insufficiency, Chronic
Inflammation

Interventions

Dialysis Solutions

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2CEI-753	Other Identifier	IRB from AO Citta Della Salute e Della Scienza di Torino

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2014Actual

Primary Completion Date

Jul 30, 2015Actual

Completion Date

Jul 30, 2015Actual

First Submitted Date

Jun 13, 2018

First Submission Date that Met QC Criteria

Jul 2, 2018

First Posted Date

Jul 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2018

Last Update Posted Date

Jul 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vincenzo Cantaluppi, Associate professor of Nephrology, A.O.U. Città della Salute e della ScienzaPrincipal Investigator

Lead Sponsor

A.O.U. Città della Salute e della ScienzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm	Experimental		Drug: Dialysis Solutions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dialysis Solutions	Drug	Solution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion	Single arm

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette		Torino	To	10126	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D007249	Inflammation

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015314	Dialysis Solutions

Ancestor Terms

ID	Term
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D045506	Therapeutic Uses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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