Protocol Biopsies in High-risk Renal Transplant Recipients

Utility Evaluation of Protocolar Renal Transplant Biopsies in High Risk Patients for Immunological Loss of Graft

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Transplant Infection; Kidney Transplant Rejection; Kidney Transplant Failure; Kidney Transplant Failure and Rejection
• Intervention / Treatment: Procedure: Percutaneous renal biopsy.

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
      • Hospital de Clinicas of Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft survival	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.	Two years post transplant.

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Roberto Ceratti Manfro, PhD, Hospital de Clínicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Kidney Transplantation; Kidney Transplant Rejection; Protocol Biopsies
• Other Study ID Numbers: 20180625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No