Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04936282

Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING)

Kidney Transplant Failure and Rejection Clinical Trial

Official title:
Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients: a Spanish Multicenter, Randomized, Controlled Parallel-group Trial: The TRAINING Study

Clinical Trial Summary

Background: Subclinical inflammation, including borderline lesions (BL), is very common (30-40%) after kidney transplantation (KT), even in low immunological risk patients, and can lead to interstitial fibrosis/tubular atrophy (IFTA) and worsening of renal function with graft loss. Few controlled studies have analyzed the therapeutic benefit of these BL on renal function and graft histology. Furthermore, these studies have only used bolus steroids, which may be insufficient to slow the progression of these lesions. Klotho, a transmembrane protein produced mainly in the kidney with antifibrotic properties, plays a crucial role in the senescence-inflammation binomial of kidney tissue. Systemic and local inflammation decrease renal tissue expression and soluble levels of α-klotho. It is therefore important to determine whether treatment of BL prevents a decrease in α klotho levels, progression of IFTA, and loss of kidney function. Methods: The TRAINING study will randomize 80 patients with low immunological risk who will receive their first KT. The aim of the study is to determine whether the treatment of early BL (3rd month post-KT) with polyclonal rabbit antithymocyte globulin (Grafalon®) (6 mg/kg/day) prevents or decreases the progression of IFTA and the worsening of graft function compared to conventional therapy after two years post-TX, as well as to analyze whether treatment of BL with Grafalon® can modify the expression and levels of klotho, as well as the pro-inflammatory cytokines that regulate its expression.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Kidney Transplant Failure and Rejection
Clinical Trial Details
NCT number NCT04936282
Study type Interventional
Source Fundación Canaria de Investigación Sanitaria
Contact Pedro Ruiz-Esteban, PhD
Phone +34951291542
Email pedro_ruiz_esteban@hotmail.com
Status Recruiting
Phase Phase 4
Start date July 5, 2022
Completion date June 30, 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04057742 - AlloSure for the Monitoring of Antibody Mediated Processes After Kidney Transplantation
Recruiting NCT03465397 - Individualization of the Immunological Risk Based on Selective Biomarkers in Living-donor Renal Recipients Phase 4
Completed NCT03437577 - Comparison of the Cognitive and Motor Effects of Treatment Between an Immediate- and Extended-release Tacrolimus (Envarsus® XR) Based Immunosuppression Regimen in Kidney Transplant Recipients Phase 1/Phase 2
Not yet recruiting NCT05282966 - Assessment of QSant™ for Underlying Allograft Rejection
Recruiting NCT04388930 - The Microbiota in Kidney Donation and Transplantation
Completed NCT03611621 - A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
Recruiting NCT05397821 - Pediatric Kidney Transplantation, Ureteroneocystostomy Techniques
Completed NCT04019353 - Cf-DNA Assay During Treatment of Acute Rejection
Active, not recruiting NCT05806749 - Immunological Tolerance in Patients With Mismatched Kidney Transplants Phase 1
Enrolling by invitation NCT05285878 - Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation Phase 2
Recruiting NCT04526431 - Tacrolimus Pharmacokinetic Subpopulations
Active, not recruiting NCT03511560 - Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation Phase 4
Recruiting NCT03438773 - Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients Phase 1
Completed NCT05388955 - Risk Assessment Tool for Graft Survival in Pediatric Kidney Transplantation
Completed NCT06394596 - Predicting Prognostic Factors in Kidney Transplantation Using A Machine Learning
Completed NCT04413916 - MiRNA in Kidney Transplantation: Association With Kidney Graft Function and Disease Process
Completed NCT03466775 - Anti-Angiotensin II Type 1 Receptor Antibodies and Kidney Transplant Outcomes N/A
Active, not recruiting NCT04733131 - Long-term Outcomes After Conversion to Belatacept
Active, not recruiting NCT03380962 - Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant Phase 1/Phase 2
Active, not recruiting NCT04154267 - Protocol Biopsies in High-risk Renal Transplant Recipients N/A