Novel biomarkers for a better evaluation of organ quality in postmoral kidney donors

Novel biomarkers for a better evaluation of organ quality in postmoral kidney donors - Biomarkers-donor

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037362

Enrollment

250

Registered

2025-07-21

Start date

2025-09-01

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Kidney transplantation (diseased donor)

Interventions

Group 1: Deceased Kidney Donors We plan to conduct the analysis of new markers of kidney function) on kidney donors and the necessary additional blood draw as a supplementary, organ-specific diagno

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In principle, all postmortem kidney organ donors in the DSO region of Baden-Württemberg for whom novel biomarkers ??are determined will be included. Child organ donors can only be included if the volume of the additional blood collection does not pose a potential risk to the donation process. The corresponding assessment is the responsibility of the medical staff of the intensive care unit of the donor hospital in consultation with the DSO coordinator. In addition, all adult (>18 years) recipients of kidney organs from the included donors after transplantation will be included in the study.

Exclusion criteria

Exclusion criteria: Insufficient documentation

Design outcomes

Primary

Measure	Time frame
The outcome data for the donor are collected from routine clinical data using an anonymized data collection form by the German Organ Donation Foundation. 30-Day Graft Outcome: Defined as poor if the estimated glomerular filtration rate (eGFR) is = 30 mL/min/1.73 m², calculated using the CKD-EPI equation.	—

Secondary

Measure	Time frame
Graft Function Classification: Immediate Graft Function (IGF): Defined as a serum creatinine (SCr) reduction ratio = 0.7. Slow Graft Function (SGF): Defined as a SCr reduction ratio < 0.7. (SCr reduction ratio = (Initial SCr - SCr on day 7) / Initial SCr) Delayed Graft Function (DGF): Definition: Requirement of kidney replacement therapy (KRT) within 7 days after transplantation, based on the treating physician’s judgment. Severity Classification: (1) No DGF: No need for KRT (i.e., IGF or SGF) (2) Mild DGF: KRT required only within the first 24 hours post-transplant (3) Moderate DGF: KRT required up to day 7 post-transplant (4) Severe DGF: KRT required beyond day 7 post-transplant	—

Measure

Time frame

Graft Function Classification: Immediate Graft Function (IGF): Defined as a serum creatinine (SCr) reduction ratio = 0.7. Slow Graft Function (SGF): Defined as a SCr reduction ratio < 0.7. (SCr reduction ratio = (Initial SCr - SCr on day 7) / Initial SCr) Delayed Graft Function (DGF): Definition: Requirement of kidney replacement therapy (KRT) within 7 days after transplantation, based on the treating physician’s judgment. Severity Classification: (1) No DGF: No need for KRT (i.e., IGF or SGF) (2) Mild DGF: KRT required only within the first 24 hours post-transplant (3) Moderate DGF: KRT required up to day 7 post-transplant (4) Severe DGF: KRT required beyond day 7 post-transplant

—

Countries

Germany

Contacts

Public ContactChristian Nusshag

Uniklinikum Heidelberg

Christian.Nusshag@med.uni-heidelberg.de+49 6221 56 310815

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026