Efficacy of Rituximab in Acute Cellular Rejection in Renal Transplant Patients

Sponsor
Hannover Medical School
Study ID
NCT01117662
Phase
PHASE3
Status
Terminated

Conditions

  • Acute Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Intravenous application of Rituximab 375mg/m² body surface in 250 ml NaCl 0,9 % over 4 hours
  • Placebo — DRUG
    Intravenous application of placebo (NaCl 0,9 %) matching active treatment

Study Details

Acute kidney allograft rejection is the major cause for a loss of graft function and has a negative impact on long-term graft survival. Anti-rejection therapy traditionally focuses on T cell-mediated mechanisms of renal allograft rejection. However, available agents that affect T-cell pathways have only little impact on long-term graft survival. There is increasing evidence that B-cells play an important role in acute transplant rejections. CD20+ B cell infiltrates in acute T-cell mediated rejections are frequent and correlate with a worse response to conventional anti-rejection treatment and an increased risk of graft loss. In one pilot study, supported by several case reports, a beneficial effect of Rituximab for the treatment of acute rejection episodes with intrarenal B-cell infiltrates was shown. However, despite the promise of these observations solid evidence is required before incorporating this treatment option into a general treatment recommendation. In a multicenter randomized placebo controlled double blind phase III trial the investigators want to demonstrate that Rituximab in addition to standard treatment with steroid-boli is superior to the standard treatment alone regarding long-term kidney function. If the proposed study proves that Rituximab treatment of acute rejections is beneficial for the long-term allograft function, the conventional rejection therapy needs to be revised to this novel concept of B- cell targeting

Key Dates

Start date
May 31, 2012
Status verified
Aug 2018
Primary completion
May 31, 2016
Completion
Aug 23, 2016

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Intravenous application of Rituximab 375mg/m² body surface in 250 ml NaCl 0,9 % over 4 hours
  • Placebo Comparator: Control
    Intravenous application of placebo (NaCl 0,9 %) matching active treatment

Primary Outcome Measure

Change of the GFR (glomerular filtration rate) one year after intervention compared to the baseline GFR before the rejection, which is calculated by a defined algorithm [ Time Frame: Baseline, 1 year ]

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