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Blood indoxyl sulfate testing to predict early recovery and acute injury after kidney transplantation

A prospective cohort study of LC-MS/MS monitoring of indoxyl sulfate for predicting early graft function recovery and differentiating acute allograft injury after kidney transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129380
Enrollment
Unknown
Registered
2026-08-04
Start date
2026-10-01
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early graft dysfunction after kidney transplantation, including delayed graft function, acute rejection, CNI nephrotoxicity, and prolonged acute tubular necrosis.

Interventions

Gold Standard:The criteria for DGF is whether dialysis is needed within the first week after surgery. The reference standard for acute rejection (AR) is a kidney transplant biopsy that meets the Banff
if a biopsy can’t be done, a combined diagnosis based on clinical signs, serology, and treatment response is used. The reference standard for non-rejection acute injury (Non-AR) is a biopsy showing no
Index test:Smart Assistant Model for Early Recovery and Damage Prediction of Transplanted Kidneys

Sponsors

Wuxi people’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult recipients aged 18 years or older undergoing first allogeneic kidney transplantation; 2. Recipients receiving tacrolimus-based maintenance immunosuppressive therapy after transplantation; 3. Written informed consent obtained, or waiver of informed consent approved when applicable.

Exclusion criteria

Exclusion criteria: 1. Recipients of combined multi-organ transplantation, such as combined liver-kidney transplantation; 2. Patients with severe preoperative hepatic dysfunction (Child-Pugh class C), which may affect indoxyl sulfate metabolism; 3.Patients with severely incomplete clinical data or loss to follow-up.

Design outcomes

Primary

MeasureTime frame
Occurrence of delayed graft function (DGF);Diagnostic performance: sensitivity, specificity, positive/negative predictive values (PPV/NPV), best cut-off value;

Countries

China

Contacts

Public ContactYao Fu

Wuxi people’s Hospital

836677067@qq.com+86 510 8535 0347

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026