Skip to content

A Multicenter Clinical Study on Assessing Kidney Allograft Health Using Donor-Derived Cell-Free DNA

A Multicenter Clinical Study on Assessing Kidney Allograft Health Using Donor-Derived Cell-Free DNA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119619
Enrollment
Unknown
Registered
2026-03-01
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Chronic kidney disease

Interventions

Gold Standard: Kidney allograft biopsy pathology (Banff classification)

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Puncture Biopsy Group: Recipients who have undergone allogeneic kidney transplantation and are scheduled for ultrasound-guided puncture biopsy of the transplanted kidney; aged 18 years or above; at least 1 month after the first transplantation; the ureteral stent tube has been removed, and no surgical-related complications have occurred. In the later analysis: Based on the pathological results of the puncture biopsy, they will be classified into various subgroups of transplanted kidneys with lesions: such as rejection reaction, recurrence of primary kidney disease, other lesions, etc.; and the negative group of transplanted kidney biopsy: no clinically significant transplanted kidney lesions were found, or only mild or non-specific changes were observed. 2. Control Group: Aged 18 years or above; at least 1 month after the first transplantation; the ureteral stent tube has been removed, and no surgical-related complications have occurred; stable condition during the follow-up period: serum creatinine fluctuation <= 15% in the past 3 months, no proteinuria, no active infection or immune-related complications, and negative peripheral blood HLA antibody test (no DSA)

Exclusion criteria

Exclusion criteria: 1. Have contraindications related to renal biopsy after transplantation; 2. Have undergone at least two kidney transplants; 3. The transplanted kidney has failed; 4. Have received organ transplantation other than the kidney; 5. Have excessive obesity leading to difficulty in biopsy; 6. Have active infections that require treatment; 7. Have complications requiring surgical intervention (such as lymph fistula, vascular or ureteral stenosis, etc.); 8. Have malignant tumors or a history of malignant tumors within the past 5 years; 9. Have severe systemic diseases; 10. Are planning to conceive, are pregnant or are breastfeeding; 11. According to the investigator's judgment, the patient's compliance is poor, then they are not suitable to participate in this study; 12. Other situations that the investigator deems not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Donor-derived cell-free DNA in blood;Donor-derived cell-free DNA in urine;Pathology of transplanted kidney biopsy;

Secondary

MeasureTime frame
Serum creatinine;Urinalysis;

Countries

China

Contacts

Public ContactFan Yu

West China Hospital of Sichuan University

kidney_fy@163.com+86 182 2406 8823

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026