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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

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.

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