Urine CXCL10 Chemokine Monitoring Post-renal Transplant

August 10, 2022 updated by: University Hospital, Basel, Switzerland
In this study investigators will investigate whether early treatment of allograft rejection, as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel, Transplantation Immunology & Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All consenting adult (age>=18) renal allograft recipients

Exclusion Criteria:

  • Human Leucocyte Antigen (HLA) -identical living donor transplantation
  • Primary non-function
  • Participation in immunosuppression interventional trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Urine CXCL10-chemokine levels will be monitored at specific time points post-transplant. Sustained elevated levels will trigger performance of a renal allograft biopsy. Any rejection will be treated. Rejection treatment according to clinical standard-of-care
Drug: Rejection treatment according to clinical standard-of-care
Standard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection
No Intervention: Control
Urine CXCL10-chemokine levels will be monitored at specific time points post-transplant, but the values are concealed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Graft loss not due to death of the patient
Time Frame: First year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
First year post-transplant
Biopsy-proven clinical acute rejection
Time Frame: 4-weeks up to 1-year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
4-weeks up to 1-year post-transplant
Subclinical T-cell mediated rejection in 1-year surveillance biopsy defined by t>0 and/or v>0
Time Frame: First year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
First year post-transplant
Interstitial fibrosis / tubular atrophy with inflammation (IFTA+i defined by the Mayo Clinic criteria) in 1-year surveillance biopsy
Time Frame: First year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
First year post-transplant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy assessed by microvascular inflammation at 1-year (ptc, g, c4d, cg)
Time Frame: First year post-transplant
Microvascular inflammation at 1-year (ptc, g, c4d, cg)
First year post-transplant
Efficacy assessed by development of IFTA from implantation to 1-year (∆ ci, ct, cv)
Time Frame: First year post-transplant
Development of IFTA from implantation to 1-year (∆ ci, ct, cv)
First year post-transplant
Efficacy assessed by number of days from transplantation to biopsy-proven clinical acute rejection
Time Frame: First year post-transplant
number of days from transplantation to biopsy-proven clinical acute rejection
First year post-transplant
Efficacy assessed by Proteinuria >500mg/day at 6- and 12-months post-transplant
Time Frame: First year post-transplant
Proteinuria >500mg/day at 6- and 12-months post-transplant
First year post-transplant
Safety assessed by total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant
Time Frame: First year post-transplant
total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant
First year post-transplant
Safety assessed by biopsy-related complications within the first year post-transplant
Time Frame: First year post-transplant
biopsy-related complications within the first year post-transplant biopsy-related complications within the first year post-transplant
First year post-transplant
Safety assessed by immunosuppression-related complications as infections and cancer within the first year post-transplant
Time Frame: First year post-transplant
immunosuppression-related complications as infections and cancer within the first year post-transplant
First year post-transplant
Graft and its cause
Time Frame: yearly up to 10 years
Long-term outcome Graft and its cause
yearly up to 10 years
Death and its cause
Time Frame: yearly up to 10 years
Long-term outcome Death and its cause
yearly up to 10 years
Allograft function measured by creatinine and eGFR
Time Frame: yearly up to 10 years
Long-term outcome Allograft function measured by creatinine and epidermal growth factor receptor (eGFR)
yearly up to 10 years
Proteinuria
Time Frame: yearly up to 10 years
Long-term outcome Proteinuria
yearly up to 10 years
Biopsy-proven rejection
Time Frame: yearly up to 10 years
Long-term outcome Biopsy-proven rejection
yearly up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan Schaub, MD, MSc, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Urine chemokine monitoring

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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