To analyze whether the anti-rejection treatment of borderline lesions can modify the expression and klotho levels, as well as proinflammatory cytokines that regulate klotho expression at both years post-transplant., Know in a controlled and randomized clinical trial, carried out in low-risk patients immunological and stable renal function, if the treatment of BL lesions, detected in the third month post-transplant, 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, after two years of post-transplant follow-up.
Conditions
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
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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