NCT03714113

Brief Summary

The aim of this study is to evaluate whether anti-HLA donor-specific antibodies monitoring can be used as an effective tool for stratification of immunological risk in Polish kidney transplant recipients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

3.2 years

First QC Date

October 3, 2018

Last Update Submit

March 8, 2021

Conditions

Kidney Transplant Rejection

Keywords

Donor-specific antibodies

Outcome Measures

Primary Outcomes (1)

  • Presence of anti-HLA donor-specific antibodies.

    Binary variable (positive/negative).

    24 months

Secondary Outcomes (6)

  • Mean fluorescence intensity (MFI) of anti-HLA DSA.

    24 months

  • Presence of C1q complement binding anti-HLA DSA.

    24 months

  • Presence of IgG1 subclass of anti-HLA DSA.

    24 months

  • Presence of IgG2 subclass of anti-HLA DSA.

    24 months

  • Presence of IgG3 subclass of anti-HLA DSA.

    24 months

  • +1 more secondary outcomes

Study Arms (1)

Kidney transplant recipients.

EXPERIMENTAL

Patients who undergo kidney transplant in 2018 or 2019.

Diagnostic Test: Anti-HLA donor-specific antibodies monitoring

Interventions

Anti-HLA donor-specific antibodies monitoringDIAGNOSTIC_TEST

Monitoring anti-HLA donor-specific antibodies in the patients serum at the time of kidney transplantation and 3, 12 and 24 months after the procedure. Blood samples from patients will be collected.

Kidney transplant recipients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Deceased-donor kidney transplant recipient
  • Older than 18 years
  • Written consent by the patient

You may not qualify if:

  • Younger than 18 years
  • Lack of written consent by the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Transplantation Medicine, Nephrology and Internal Medicine

Warsaw, 02-006, Poland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 22, 2018

Study Start

October 1, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations

PL(1)