Here is the design of a clinical trial:

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

Included conditions:
- Kidney Transplant Failure and Rejection

Study Armgroups:
- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': '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).', 'interventionNames': ['Drug: Grafalon']}
- {'label': 'Normal treatment', 'type': 'ACTIVE_COMPARATOR', 'description': 'Normal treatment (Steroids, tacrolimus and mycophenolate) arm', 'interventionNames': ['Drug: Normal Treatment']}

Interventions:
- {'type': 'DRUG', 'name': 'Grafalon', 'description': '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).', 'armGroupLabels': ['Experimental']}
- {'type': 'DRUG', 'name': 'Normal Treatment', 'description': '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)', 'armGroupLabels': ['Normal treatment']}

Primary Outcomes:
- {'measure': 'Presence of interstitial fibrosis/tubular atrophy (IFTA)', 'description': 'Measurement at 24 months according to the Banff classification. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of biopsies from solid organ transplant.', 'timeFrame': '24 months'}
- {'measure': 'Renal function measured with CKD-EPI', 'description': 'Renal function after kidney transplant in both groups at 24 months measured according to glomerular filtration rate determined by CKD-EPI formula', 'timeFrame': '24 months'}

Please estimate the sample size based on the assumption: 
A power of 80% (Beta = 0.20), a statistical risk of 5% (alpha = 0.05), and a 15% loss to follow-up.
Sample size
          Data analyzed in previous studies where renal function is compared in patients with BL versus those without inflammation have been used as reference points [32, 33]. To detect a difference in GFR of 10âml/min at 24âmonths post-KT in both groups with an estimated standard deviation in one of the groups of 15âml/min, a power of 80% (Betaâ=â0.20), and a statistical risk of 5% (alphaâ=â0.05), a total of 70 patients with BL (35 in each therapeutic arm) is required. Assuming a 15% loss to follow-up, 80 patients (40 in each group) are needed for the evaluation of efficacy (Epidat 3.1).