Evaluation of the Outcomes of Kidney Biopsies in Deceased Donors in the Emilia-Romagna Region
NCT07932457, Recruiting, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of the Outcomes of Kidney Biopsies in Deceased Donors in the Emilia-Romagna Region | ClinicalTrials.gov |
| NCT number | NCT07932457 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 300 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna | ClinicalTrials.gov |
| Conditions | Kidney Transplant, Kidney Transplant Donor | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | The primary objective of the study is to determine whether there is a difference-and, if so, to what extent-in terms of TMA and ATN in pre-transplant kidney biopsies from DCD donors compared to DBD donors. | Pre organ implantation | TMA: presence, percentage, and severity (mild/moderate/severe) ATN: presence, percentage, and severity (mild/moderate/severe) | ClinicalTrials.gov |
| Secondary | Compare the prevalence of different ATN groups in DCD and DBD | Pre organ implantation | ATN: Presence, Percentage, and Severity (mild/moderate/severe) | ClinicalTrials.gov |
| Secondary | Compare the epidemiological data for transplants from DCD and DBD donors | 1, 3, and 5 years after transplantation | Graft survival (percentage) Cause of graft loss (rejection, disease recurrence, thrombosis, other) Recipient survival (percentage) Cause of patient death (infectiou, cardiovascular, neoplastic, other) (percentage) Post-transplant complications (rejection, infectious complications, surgical complications) (percentage) PNF and DGF (percentage) Post-transplant renal function trends (eGFR calculated using the CKD-EPI formula) | ClinicalTrials.gov |
| Secondary | Analysis of histological data from pre-implantation kidney biopsies | Pre organ implantation | Total Karpinski score and the individual parameters that comprise it (glomerulosclerosis, tubular atrophy, interstitial fibrosis, and thickening of the arterial wall) TMA: presence, percentage, and severity (mild/moderate/severe) | ClinicalTrials.gov |
| Secondary | Determine whether the relationship between TMA and clinical transplant outcomes is affected by DCD/DBD status | For the first 2 outcomes: January 2027 for the retrospective portion. Twice a year from 2030 until the end of the study (January 2034) for the prospective portion. For the second 2 outcomes: 1, 3, and 5 years after transplantation | DGF (percentage) PNF (percentage) Recipient survival (percent) eGFR calculated using the CKD-EPI formula (mL/min/1.73 m²) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)