Protocol Biopsies in High-risk Renal Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT04154267|
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplant Rejection Kidney Transplant Failure Kidney Transplant Infection Kidney Transplant Failure and Rejection||Procedure: Percutaneous renal biopsy.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||We will include 100 patients in this work. In the first 48 hours after transplantation 50 patients will be randomized in the protocol biopsy and noninvasive evaluation group and 50 patients for noninvasive evaluation only.|
|Masking:||None (Open Label)|
|Official Title:||Utility Evaluation of Protocolar Renal Transplant Biopsies in High Risk Patients for Immunological Loss of Graft|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||October 15, 2022|
|Estimated Study Completion Date :||December 30, 2022|
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.
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
No Intervention: Control
Patients will only undergo routine noninvasive evaluation at this post-transplant period
- Incidence of rejection. [ Time Frame: Three months post transplant. ]To evaluate the incidence of subclinical, cellular and antibody-mediated rejections in protocol biopsies performed on patients at high immune risk who underwent kidney transplantation.
- Graft survival [ Time Frame: Two years post transplant. ]Comparison of glomerular filtration rate at 2 years after transplantation between groups of patients with and without protocol biopsy using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154267
|Contact: Rodrigo Fontanive Franco, Dr||+55 51 email@example.com|
|Contact: Roberto Ceratti Manfro, Dr.||+55(51)firstname.lastname@example.org|
|Principal Investigator:||Roberto Ceratti Manfro, PhD||Hospital de Clínicas de Porto Alegre|