86
Participants
Start Date
January 31, 2014
Primary Completion Date
June 26, 2019
Study Completion Date
June 26, 2019
TACROLIMUS
Initial dose: 0.05 mg/Kg/day, adjusted to achieve blood trough levels of 5-7 ng/ml) for six months. Starting at the end of month 6, tacrolimus dosage will be reduced by 25% per month, resulting in a complete withdrawal at the end of month 9.
RITUXIMAB
A dose 1 g IV will be given during month 6 (at day 180), before the onset of tacrolimus dose reduction
METHYLPREDNISOLONE
Month 1: 1g IV methylprednisolone daily for three doses (days 1, 2, and 3), Oral methylprednisolone (0.5mg/kg/day) for 27 days (days 4 to 30). Months 3, and 5: Repeat Month 1.
CYCLOPHOSPHAMIDE
Month 2: Oral Cyclophosphamide (2.0 mg/kg/day) for 30 days. Months 4, and 6: Repeat month 2.
Hospital 12 de Octubre, Madrid
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER
Hospital Universitario Fundación Alcorcón
OTHER
Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre
UNKNOWN
Biobanco REDinREN
UNKNOWN
ERA-EDTA
UNKNOWN
REDinREN
UNKNOWN
Spanish Society of Nephrology
OTHER
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
OTHER
University Hospital, Aachen
OTHER
Hospital Universitario 12 de Octubre
OTHER