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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
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Rodrigo Fontanive Franco, Dr +55 51 3359-8876 rodrigofon@uol.com.br
Contact: Roberto Ceratti Manfro, Dr. +55(51)33598121 rmanfro@hcpa.edu.br

Locations
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Brazil
Hospital de Clinicas of Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
Contact: Rodrigo Franco, Dr.    555133598876    rffranco@hcpa.edu.br   
Contact: Roberto Manfro, Dr.    555133598876    rmanfro@hcpa.edu.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Roberto Ceratti Manfro, PhD Hospital de Clínicas de Porto Alegre
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT04154267    
Other Study ID Numbers: 20180625
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Kidney Transplantation
Protocol Biopsies
Kidney Transplant Rejection