Urine CXCL10 Chemokine Monitoring Post-renal Transplant | NCT03140514 | Trialant

Urine CXCL10 Chemokine Monitoring Post-renal Transplant | NCT03140514 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rejection treatment according to clinical standard-of-care	Drug	Standard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Efficacy assessed by microvascular inflammation at 1-year (ptc, g, c4d, cg)	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)

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37228005	Derived	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.