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Completed

NCT Number: NCT03140514

Urine CXCL10 Chemokine Monitoring Post-renal Transplant

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

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Key information

Conditions

Renal Transplant Rejection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Transplantation Immunology & Nephrology

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rejection treatment according to clinical standard-of-care

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Graft and its cause

    Time frame: yearly up to 10 years

    Long-term outcome Graft and its cause

  9. Death and its cause

    Time frame: yearly up to 10 years

    Long-term outcome Death and its cause

  10. 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)

  11. Proteinuria

    Time frame: yearly up to 10 years

    Long-term outcome Proteinuria

  12. Biopsy-proven rejection

    Time frame: yearly up to 10 years

    Long-term outcome Biopsy-proven rejection

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 4, 2017
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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