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

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519895-23-00
Enrollment
80
Registered
2025-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

after two years of post-transplant follow-up., as well as proinflammatory cytokines that regulate klotho expression at both years post-transplant., carried out in low-risk patients immunological and stable renal function, detected in the third month post-transplant, if the treatment of BL lesions, Know in a controlled and randomized clinical trial, To analyze whether the anti-rejection treatment of borderline lesions can modify the expression and klotho levels, with rabbit polyclonal antilymphocytic globulin prevents or slows the progression of chronic histological lesions of the graft (FIAT) and the deterioration of its function compared to clinical follow-up conventional

Brief summary

Presence of Interstitial Fibrosis and Tubular Atrophy (FIAT) and calculated renal function of the graft with CKD-EPI at 24 months of the study in both therapeutic arms.

Detailed description

Patient and graft survival.  Rate of clinical and biopsy-confirmed acute rejection, and proteinuria at 3, 6, 12 and 24 months.  Blood pressure figures and number of hypotensive agents, lipid levels and need for lipid-lowering, and weight and BMI increase.  Rate of post-transplant diabetes (PTDM) or glucose intolerance at one year and the second year of transplantation according to ADA criteria.  Adherence to immunosuppressive treatment evaluated using the Basel scale.

Interventions

Sponsors

Fundacion Canaria Instituto De Investigacion Sanitaria De Canarias
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Presence of Interstitial Fibrosis and Tubular Atrophy (FIAT) and calculated renal function of the graft with CKD-EPI at 24 months of the study in both therapeutic arms.

Secondary

MeasureTime frame
Patient and graft survival.  Rate of clinical and biopsy-confirmed acute rejection, and proteinuria at 3, 6, 12 and 24 months.  Blood pressure figures and number of hypotensive agents, lipid levels and need for lipid-lowering, and weight and BMI increase.  Rate of post-transplant diabetes (PTDM) or glucose intolerance at one year and the second year of transplantation according to ADA criteria.  Adherence to immunosuppressive treatment evaluated using the Basel scale.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026