Trials / Unknown
UnknownNCT04154267
Protocol Biopsies in High-risk Renal Transplant Recipients
Utility Evaluation of Protocolar Renal Transplant Biopsies in High Risk Patients for Immunological Loss of Graft
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- Hospital de Clinicas de Porto Alegre · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The present study aims to evaluate the usefulness of protocol biopsies in a cohort of renal transplant patients of high immunological risk for graft injury and loss.
Detailed description
This will be a prospective study undertaken at the Renal Transplant Unit of Hospital of Clinics of Porto Alegre. In addition to the routine evaluation commonly carried-out at this post-transplant period, protocol biopsies will be performed at the 10th-week post-transplantation in high-risk transplant recipients. Biopsy fragments will be evaluated for tissue immune aggression (mainly cellular and antibody-mediated rejections) and other conditions such as infections, particularly polyomavirus and cytomegalovirus and medication toxicities. The presence of donor-specific antibodies and graft-damaging infectious agents will also be searched in the peripheral blood at the time of biopsy.One hundred patients will be randomized to a protocol biopsy and noninvasive assessment or only for noninvasive assessment. The hypothesis of the study is that biopsies will lead to treatments that may allow better outcomes of renal transplants, related to lowering the progression of subclinical aggressions, avoiding or delaying graft loss and preserving or decreasing the rate of loss of the glomerular filtration rate. Therefore, this strategy has the possibility of reaching clinical practice routine and thus contribute positively to the management of renal transplant patients.
Conditions
- Kidney Transplant Rejection
- Kidney Transplant Failure
- Kidney Transplant Infection
- Kidney Transplant Failure and Rejection
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Percutaneous renal biopsy. | The biopsy will be performed with a 16 Gauge semi-automatic needle gun for renal biopsy under real-time ultrasound control. After the procedure will be done ultrasound control |
Timeline
- Start date
- 2020-02-01
- Primary completion
- 2023-12-15
- Completion
- 2024-02-28
- First posted
- 2019-11-06
- Last updated
- 2023-06-28
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04154267. Inclusion in this directory is not an endorsement.