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

Launched by FUNDACIÓN CANARIA DE INVESTIGACIÓN SANITARIA · Jun 18, 2021

Keywords

ClinConnect Summary

The TRAINING clinical trial is studying a treatment for patients who have had a kidney transplant and are showing early signs of inflammation, called borderline lesions. These lesions can lead to kidney damage and loss of function over time. The trial aims to see if using a specific medication, Grafalon®, can help prevent this damage and improve kidney health over two years compared to standard treatments. This study is important because it could help improve outcomes for kidney transplant patients by addressing these early signs of inflammation more effectively.

To be eligible for this trial, participants must be 18 years or older, have received their first kidney transplant from either a deceased or living donor, and have low immunological risk (meaning they are less likely to reject the transplant). They should also show signs of borderline lesions three months after their transplant. Participants can expect to receive either the new treatment or standard care and will be monitored over two years to assess the health of their kidney and related markers in their body. This research could lead to better strategies for managing kidney health in transplant patients, so it's a significant opportunity for those who qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients of either sex, older than 18 years, with no immunological risk (PRA\<20% and absence of DSA), who receive their first deceased donor or living donor KT.
• • 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:
• • Recipients of a multi-organ transplant.
• • 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.