Protocol Biopsies in High-risk Renal Transplant Recipients

NCT04154267 | Unknown

• 1 other identifier: 20180625
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Rejection; Kidney Transplant Failure; Kidney Transplant Infection; Kidney Transplant Failure and Rejection

Keywords

Kidney Transplantation; Protocol Biopsies; Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• Incidence of rejection.

  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.

  Three months post transplant.

Secondary Outcomes (1)

• Graft survival

  Two years post transplant.

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Control

NO INTERVENTION

Patients will only undergo routine noninvasive evaluation at this post-transplant period

Interventions

Percutaneous renal biopsy. PROCEDURE

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

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Roberto Ceratti Manfro, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: November 6, 2019
• Study Start: February 1, 2020
• Primary Completion: December 15, 2023
• Study Completion: February 28, 2024
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)