Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING)
NCT ID: NCT04936282
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2022-07-05
2024-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental
Normal treatment (Steroids, tacrolimus and mycophenolate) for first 90 days, then add Grafalon single-dose if borderline lesions are present in protocol biopsy (performed at third month post-transplantation).
Grafalon
When Borderline lesions are present in protocol biopsy, administer Grafalon ® 6 mg/kg/day in a single day. Then continue with the normal treatment: Steroids (5 mg/day), tacrolimus (0.1 mg/kg/day) and mycophenolate (1000 mg/day).
Normal treatment
Normal treatment (Steroids, tacrolimus and mycophenolate) arm
Normal Treatment
When Borderline lesions are present in protocol biopsy, administer the normal treatment: Steroids (5 mg/day), tacrolimus (0.1 mg/kg/day) and mycophenolate (1000 mg/day)
Interventions
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Grafalon
When Borderline lesions are present in protocol biopsy, administer Grafalon ® 6 mg/kg/day in a single day. Then continue with the normal treatment: Steroids (5 mg/day), tacrolimus (0.1 mg/kg/day) and mycophenolate (1000 mg/day).
Normal Treatment
When Borderline lesions are present in protocol biopsy, administer the normal treatment: Steroids (5 mg/day), tacrolimus (0.1 mg/kg/day) and mycophenolate (1000 mg/day)
Eligibility Criteria
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Inclusion Criteria
* Presence of BL, excluding isolated inflammation (t0, i\>0) and isolated tubulitis (t\>0, i0).
* Patients receiving tacrolimus in combination with mycophenolic acid (MPA) and steroids.
* Absence of clinical or subclinical and histological immunological dysfunction before randomization.
* Absence of de novo DSA anti-HLA antibodies at the time of randomization.
* Provision of written informed consent.
* Acceptance of efficient contraception in women.
Exclusion Criteria
* Re-transplants.
* Patients without inflammation in the third month protocol biopsy (i0,t0), or with isolated inflammation without tubulitis (t0,i\>0) or isolated tubulitis without inflammation (t\>0,i0).
* Presence of DSA antibodies before transplantation or at randomization.
* Cold ischemia time \>30 hours.
* Serum creatinine \>2.5 mg/dl or proteinuria \>1 g/day at randomization.
* Presence of significant thrombopenia (\<100,000/mm3) or leukopenia (\<3000 mm/3) at randomization.
* Previous episode of clinical or subclinical rejection (≥IA) before randomization.
* CMV disease in the first three months after transplantation.
* BK-polyomavirus nephropathy at randomization.
* Recurrent or de novo glomerulonephritis.
* Treatment with immunosuppressive drugs other than those in this clinical trial.
* Patients who are positive for the human immunodeficiency virus (HIV) or with severe systemic infection, who, in the opinion of the investigator, require continued therapy.
* Previous (within the last 5 years) or present malignancy, except excised basal or squamous cell carcinoma.
18 Years
ALL
No
Sponsors
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Fundación Canaria de Investigación Sanitaria
OTHER
Responsible Party
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Locations
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Hospital Universitario de Canarias
Santa Cruz de Tenerife, None Selected, Spain
Fundación Puigvert
Barcelona, , Spain
Hospital Universitari Valld´Hebron
Barcelona, , Spain
Veronica Lopez Jimenez
Málaga, , Spain
Countries
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Central Contacts
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Facility Contacts
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Domingo Hernández, MD,PhD
Role: primary
Luis Guirado, MD, PhD
Role: primary
Manel Perello, MD
Role: primary
Verónica López Jiménez, MD, PhD
Role: primary
References
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Other Identifiers
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TRAINING
Identifier Type: -
Identifier Source: org_study_id