Urine CXCL10 Chemokine Monitoring Post-renal Transplant

NCT ID: NCT03140514

Last Updated: 2022-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-28

Study Completion Date

2022-07-15

Brief Summary

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In this study investigators will investigate whether early treatment of allograft rejection, as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.

Detailed Description

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Conditions

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Renal Transplant Rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Rejection treatment according to clinical standard-of-care

Intervention Type DRUG

Standard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection

Control

Urine CXCL10-chemokine levels will be monitored at specific time points post-transplant, but the values are concealed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rejection treatment according to clinical standard-of-care

Standard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Schaub, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel, Transplantation Immunology & Nephrology

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Hirt-Minkowski P, Handschin J, Stampf S, Hopfer H, Menter T, Senn L, Honger G, Wehmeier C, Amico P, Steiger J, Koller M, Dickenmann M, Schaub S. Randomized Trial to Assess the Clinical Utility of Renal Allograft Monitoring by Urine CXCL10 Chemokine. J Am Soc Nephrol. 2023 Aug 1;34(8):1456-1469. doi: 10.1681/ASN.0000000000000160. Epub 2023 May 25.

Reference Type DERIVED
PMID: 37228005 (View on PubMed)

Other Identifiers

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Urine chemokine monitoring

Identifier Type: -

Identifier Source: org_study_id

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