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Completed

NCT Number: NCT00255593

Safety and Efficacy Study of Rituximab in Renal Transplantation

Current strategies for the medical management of transplant patients are largely focused on the prevention and treatment of T-lymphocyte mediated processes. However there is an increasing evidence to suggest that B-lymphocytes have a role in the otherwise classic T-cell mediated rejection of transplants by there ability to act as antigen presenting cells and T-cell activators. Thus there is a significant medical need for effective therapies targeting B cells of transplant patients.One such potential therapy would be to use rituximab, a monoclonal antibody against B-cells in all renal transplant patients. In the present study the efficacy and safety of prophylactic rituximab is studied.

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Key information

Conditions

Renal Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Transplantation Surgery, Karolinska University Hospital

Stockholm, 141 86, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or above
  • Recipients of first or second renal transplants
  • Recipients of kidneys from living or cadaveric donors
  • Single organ recipients (kidney only)
  • Patients providing written informed consent
  • Patients cooperative and able to complete all the assessment procedures

Exclusion criteria

  • Patients receiving other immunosuppressive therapy within the preceding 28 days
  • Recipients of HLA-identical sibling kidneys
  • Patients with flow-PRA >50% within 6 months prior to enrolment
  • Recent history of malignancy
  • Active infection
  • Pregnant or lactating females
  • Women of childbearing potential not willing to use reliable form of contraception

Treatment and study plan

Rituximab

Drug

Primary outcomes

  1. Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation

Secondary outcomes

  1. Renal function at 6 months

  2. Incidence of infections

  3. Incidence of rituximab-related adverse events

  4. Incidence of malignancies

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

A Prospective, Randomised, Placebo Controlled, Multicenter Study of the Efficacy and Safety of Rituximab as Induction Therapy Together With Tacrolimus, Mycophenolate Mofetil and Steroids for Patients Undergoing Renal Transplantation

Important dates

Study start
2005
Study completion
2007
First posted
Nov 21, 2005
Registry last updated
Nov 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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