NCT03140514

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 28, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

4.8 years

First QC Date

May 2, 2017

Last Update Submit

August 10, 2022

Conditions

Renal Transplant Rejection

Keywords

Urine chemokine monitoring

Outcome Measures

Primary Outcomes (4)

  • Graft loss not due to death of the patient

    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

    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

    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

    1-year composite outcome consisting of at least one of the primary outcomes 1 to 4

    First year post-transplant

Secondary Outcomes (12)

  • Efficacy assessed by 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)

    First year post-transplant

  • Efficacy assessed by 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

    First year post-transplant

  • Safety assessed by total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant

    First year post-transplant

  • +7 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Rejection treatment according to clinical standard-of-careDRUG

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

Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Transplantation Immunology & Nephrology

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 37228005DERIVED

Study Officials

  • Stefan Schaub, MD, MSc

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 4, 2017

Study Start

September 28, 2017

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations

CH(1)