CompletedPhase 2/3

Urine CXCL10 Monitoring Trial in Kidney Transplant

Australia, Canada260 participantsStarted 2018-04-03

Plain-language summary

This is a Phase II-III multi-center prospective randomized controlled clinical trial of incident adult renal transplant patients. The primary objective of this study is to determine if the early treatment of rejection, as detected by urinary CXCL10, will improve renal allograft outcomes.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must be able to understand and provide written informed consent
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. All ethnic and gender groups will have equal access to the study
✓. Incident adult (age ≥18) renal transplant patients with a living or deceased donor kidney transplant
✓. Confirmed elevated urine CXCL10:Cr without a urinary tract infection or gross hematuria.

Exclusion criteria

✕. Primary non-function
✕. Blood group (ABO) incompatible
✕. Pre-transplant donor specific antibody (DSA) positive (MFI\>1000 OR positive flow crossmatch)
✕. Human leukocyte (HLA) 0 HLA antigen D-related (DR) + 0 major HLA class 2 (DQ) mismatch
✕. Presence of other transplanted organ or co-transplanted organ
✕. Medical contraindication to biopsy or rejection treatment
✕. Followed outside of investigational center
✕. Participation in other interventional trials within 4-weeks post-transplant or anytime post-transplant till study end at 12-months

What they're measuring

Death-censored graft loss

Timeframe: 2 weeks-12 months post-transplant

Clinical indication biopsy-proven acute rejection

Timeframe: 2 weeks-12 months post-transplant

De novo donor specific antibody development

Timeframe: 2 weeks-12 months post-transplant

Subclinical tubulitis

Timeframe: 12-month study exit biopsy

Interstitial fibrosis and inflammation (IFTA + i)

Timeframe: 12-month study exit biopsy

Trial details

NCT IDNCT03206801

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-06

View on ClinicalTrials.gov More Kidney Transplant; Complications trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Participants must be able to understand and provide written informed consent
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. All ethnic and gender groups will have equal access to the study
✓. Incident adult (age ≥18) renal transplant patients with a living or deceased donor kidney transplant
✓. Confirmed elevated urine CXCL10:Cr without a urinary tract infection or gross hematuria.

Exclusion criteria

✕. Primary non-function
✕. Blood group (ABO) incompatible
✕. Pre-transplant donor specific antibody (DSA) positive (MFI\>1000 OR positive flow crossmatch)
✕. Human leukocyte (HLA) 0 HLA antigen D-related (DR) + 0 major HLA class 2 (DQ) mismatch
✕. Presence of other transplanted organ or co-transplanted organ
✕. Medical contraindication to biopsy or rejection treatment
✕. Followed outside of investigational center
✕. Participation in other interventional trials within 4-weeks post-transplant or anytime post-transplant till study end at 12-months

What they're measuring

Death-censored graft loss

Timeframe: 2 weeks-12 months post-transplant

Clinical indication biopsy-proven acute rejection

Timeframe: 2 weeks-12 months post-transplant

De novo donor specific antibody development

Timeframe: 2 weeks-12 months post-transplant

Subclinical tubulitis

Timeframe: 12-month study exit biopsy

Interstitial fibrosis and inflammation (IFTA + i)

Timeframe: 12-month study exit biopsy