Clinical trial NCT04154267: Protocol Biopsies in High-risk Renal Transplant Recipients
Official title: Utility Evaluation of Protocolar Renal Transplant Biopsies in High Risk Patients for Immunological Loss of Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplant Rejection
Kidney Transplant Failure
Kidney Transplant Infection
Kidney Transplant Failure and Rejection
Keywords: Kidney Transplantation
Protocol Biopsies
Kidney Transplant Rejection
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 119
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

Adult kidney transplants, with high immunological risk, who consented to participate in the study by signing the informed consent form. The high immune risk is defined by:

* Positive pre-transplant T-lymphocyte cross-test by flow cytometry (channel deviation greater than 62);
* Flow cytometry pre-transplantation positive B lymphocyte cross-test (channel deviation greater than 112);
* Calculated panel reactivity greater than 50% in class I and / or class II;
* Presence in the pre-transplantation serum of donor class I and / or II anti-Human Leukocyte Antigen antibodies with intensity and fluorescence greater than 1000;
* Occurrence of cellular or antibody-mediated rejection within 30 days prior to the date of the protocol biopsy.

Exclusion Criteria:

* Patients with contraindication to renal graft biopsy;
* Patients whose biopsy fragments are not representative;
* Patients with graft dysfunction in whom renal graft biopsy is indicated within 4 weeks prior to protocol biopsy.

Primary outcomes:
measure: Incidence of rejection.
timeFrame: Three months post transplant.
Secondary outcomes:
measure: Graft survival
timeFrame: Two years post transplant.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas of Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Roberto Ceratti Manfro, PhD
role: PRINCIPAL_INVESTIGATOR
References: