NCT_ID: NCT05477082
Clinical Trial Link
Brief Summaries
| Sequence: | 30583392 |
| Description | The objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. The study hypothesizes that blood gene expression profile and donor-derived cell-free DNA biomarkers (omnigraf) can be used to predict acute rejection and monitor its response to treatment. |
Studies
| Study First Submitted Date | 2022-07-25 |
| Study First Posted Date | 2022-07-28 |
| Last Update Posted Date | 2023-08-01 |
| Start Month Year | August 1, 2023 |
| Primary Completion Month Year | May 27, 2024 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-08-01 |
Facilities
| Sequence: | 198803460 |
| Name | University of Minnesota |
| City | Minneapolis |
| State | Minnesota |
| Zip | 55455 |
| Country | United States |
Facility Contacts
| Sequence: | 27966318 |
| Facility Id | 198803460 |
| Contact Type | primary |
| Name | Amy Hanson |
| amhanson@umn.edu | |
| Phone | 612-626-4424 |
Conditions
| Sequence: | 51857806 |
| Name | Rejection of Kidney Allograft |
| Downcase Name | rejection of kidney allograft |
Id Information
| Sequence: | 39907551 |
| Id Source | org_study_id |
| Id Value | PEDS-2022-30750 |
Countries
| Sequence: | 42305717 |
| Name | United States |
| Removed | False |
Interventions
| Sequence: | 52178016 |
| Intervention Type | Other |
| Name | Observational group |
| Description | Includes blood draws and data collection only |
Keywords
| Sequence: | 79358030 | Sequence: | 79358031 | Sequence: | 79358032 | Sequence: | 79358033 | Sequence: | 79358034 |
| Name | acute rejection | Name | kidney transplant | Name | pediatric | Name | biomarker | Name | cell free DNA |
| Downcase Name | acute rejection | Downcase Name | kidney transplant | Downcase Name | pediatric | Downcase Name | biomarker | Downcase Name | cell free dna |
Design Outcomes
| Sequence: | 176361966 | Sequence: | 176361967 |
| Outcome Type | primary | Outcome Type | primary |
| Measure | Biopsy-proven acute rejection | Measure | Clinical resolution of rejection |
| Time Frame | 7 days from baseline | Time Frame | 8 weeks from baseline |
| Description | Yes or No assessment | Description | Yes or No assessment; defined as improvement in serum creatinine to a value that is within 25% of baseline serum creatinine |
Sponsors
| Sequence: | 48029237 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | University of Minnesota |
Overall Officials
| Sequence: | 29102903 |
| Role | Principal Investigator |
| Name | Sarah Kizilbash, MD |
| Affiliation | University of Minnesota |
Central Contacts
| Sequence: | 11944384 |
| Contact Type | primary |
| Name | Amy Hanson |
| Phone | 612-626-4424 |
| amhanson@umn.edu | |
| Role | Contact |
Eligibilities
| Sequence: | 30582173 |
| Sampling Method | Non-Probability Sample |
| Gender | All |
| Minimum Age | N/A |
| Maximum Age | 21 Years |
| Healthy Volunteers | No |
| Population | Pediatric kidney transplant recipients, ages < 21 years, scheduled to undergo a for-cause kidney biopsy to rule out graft rejection |
| Criteria | Inclusion Criteria: Kidney transplant recipients Participants undergoing a for-cause kidney biopsy to rule out graft rejection Ages 21 years and less Exclusion Criteria: Participants who have opted out of research Patients, less than 18 years of age, whose parents or legal guardians are illiterate and cannot read. Participants, 18 years and older, who are illiterate and cannot read. Participants, less than 18 years of age, whose parents or legal guardians do not speak English. Participants, 18 years and older, who do not speak English Participants who are pregnant as confirmed by medical records |
| Adult | True |
| Child | True |
| Older Adult | False |
Calculated Values
| Sequence: | 253856461 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Maximum Age Num | 21 |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
Designs
| Sequence: | 30330338 |
| Observational Model | Cohort |
| Time Perspective | Prospective |
Responsible Parties
| Sequence: | 28709128 |
| Responsible Party Type | Sponsor |