NCT07006831

A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Devyser Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ.

Detailed description

This is a prospective, multicenter sample collection study within a kidney transplant population. Whole blood samples and clinical data will be obtained from each participant at the time of indication biopsy (prior to the biopsy procedure). De-identified leftover retrospective gDNA screening samples from the paired donor(s) will also be obtained.

Conditions

• Kidney Disease
• Kidney Transplant
• Transplant Recipient
• Renal Function
• Cell-free DNA
• NGS

Timeline

• Start date: 2025-11-14
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2025-06-05
• Last updated: 2025-12-17

Locations

6 sites across 1 country: United States