NCT02981992

Brief Summary

In this observational study, the investigators evaluated the Treg number and function in a population of patients undergoing hemodialysis (HD). In particular, the investigators considered the relationship of Treg cell status with the different HD modalities and clinical parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
Last Updated

December 5, 2016

Status Verified

November 1, 2016

Enrollment Period

3 years

First QC Date

November 26, 2016

Last Update Submit

December 2, 2016

Conditions

Haemodialysis ComplicationImmune Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Treg number

    Assessment of the number of Treg by flow cytometry.

    Assessment of Treg number at basal control and then every 3 months for a total study period of 12 months

Secondary Outcomes (2)

  • Treg function

    Assessment of Treg function at basal control and then every 3 months for a total study period of 12 months

  • Effect of dialysis modality

    Analysis of the number and function of Treg cells in function of the type of dialysis treatment at basal control and then every 6 months for a total study period of 12 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total number of 30 prevalent patients undergoing chronic renal replacement terapy with hemodialysis (HD) has been included in the evaluation. The study duration was 12 months, with a check of the number and function of Treg every 3 months. During the study patients were subjected to dialysis and farmacology treatment as usual, without any alteration linked specifically to this protocol. The number and function of Treg were measured as a percentage of CD4+CD25bright+pre-dialysis in the last week of each third month of the study.

You may qualify if:

  • Patients with spKt/V ≥ 1,2

You may not qualify if:

  • Cancer
  • Pregnant or breastfeeding
  • Sepsis
  • Kidney or other organ transplant
  • Major cardiovascular events in the previous 3 months
  • Patients unable to understand or interdicted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico "San Matteo"

Pavia, Italy

Location

Related Publications (6)

  • Hendrikx TK, van Gurp EA, Mol WM, Schoordijk W, Sewgobind VD, Ijzermans JN, Weimar W, Baan CC. End-stage renal failure and regulatory activities of CD4+CD25bright+FoxP3+ T-cells. Nephrol Dial Transplant. 2009 Jun;24(6):1969-78. doi: 10.1093/ndt/gfp005. Epub 2009 Feb 4.

    PMID: 19193737BACKGROUND

  • Sewgobind VD, van der Laan LJ, Kho MM, Kraaijeveld R, Korevaar SS, van Dam T, Ijzermans JN, Weimar W, Baan CC. Characterization of rabbit antithymocyte globulins-induced CD25+ regulatory T cells from cells of patients with end-stage renal disease. Transplantation. 2010 Mar 27;89(6):655-66. doi: 10.1097/TP.0b013e3181c9cc7a.

    PMID: 20164820BACKGROUND

  • Sharif MR, Chitsazian Z, Moosavian M, Raygan F, Nikoueinejad H, Sharif AR, Einollahi B. Immune disorders in hemodialysis patients. Iran J Kidney Dis. 2015 Mar;9(2):84-96.

    PMID: 25851286BACKGROUND

  • Uda S, Mizobuchi M, Akizawa T. Biocompatible characteristics of high-performance membranes. Contrib Nephrol. 2011;173:23-29. doi: 10.1159/000328941. Epub 2011 Aug 8.

    PMID: 21865772BACKGROUND

  • Libetta C, Esposito P, Sepe V, Portalupi V, Margiotta E, Canevari M, Dal Canton A. Dialysis treatment and regulatory T cells. Nephrol Dial Transplant. 2010 May;25(5):1723-7. doi: 10.1093/ndt/gfq055. Epub 2010 Feb 15. No abstract available.

    PMID: 20157169RESULT

  • Sepe V, Gregorini M, Rampino T, Esposito P, Coppo R, Galli F, Libetta C. Vitamin e-loaded membrane dialyzers reduce hemodialysis inflammaging. BMC Nephrol. 2019 Nov 15;20(1):412. doi: 10.1186/s12882-019-1585-6.

    PMID: 31729973DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sample used to evaluate T cell subpopulations

MeSH Terms

Conditions

Immune System Diseases

Study Officials

  • Carmelo Libetta, Prof

    Fondazione Policlinico "San Matteo", Pavia- Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2016

First Posted

December 5, 2016

Study Start

February 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2016

Last Updated

December 5, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)