Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous Nephropathy
Status:
Completed
Trial end date:
2019-06-26
Target enrollment:
Participant gender:
Summary
In this study, investigators will evaluated the long-term efficacy and safety (two years) of
Tacrolimus-Rituximab (RTX) therapy compared to Methylprednisolone-Cyclophosphamide (CYC)
therapy in patients with primary Membranous Nephropathy (MN).
PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus leads to a greater
increase in the proportion of primary MN patients with Complete or Partial Remission when
compared with patients receiving standard treatment. It will be assessed 24 months after the
beginning of treatment.
Phase of the trial: and design: Phase III study, open label, randomized, and active
controlled trial.
This study will have 3 stages: screening and recruitment of patients for 18 months, treatment
period for six months in corticosteroids plus CYC group and 9 months in Tacrolimus-RTX group,
and finally post-treatment follow-up period until to complete 24 months of follow-up since
initial treatment.
This study will compare the standard therapy for primary MN patients with nephrotic range
proteinuria (active control of steroids plus CYC) with a novel sequential therapy of
tacrolimus and RTX, an approach of potential high efficacy, low toxicity and more acceptable
safety profile.
Phase:
Phase 3
Details
Lead Sponsor:
Hospital Universitario 12 de Octubre
Collaborators:
Biobanco REDinREN ERA-EDTA Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre Hospital Universitario Fundación Alcorcón Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz REDinREN Sociedad Española de Nefrología Spanish Society of Nephrology University Hospital, Aachen