Safety and Efficacy Study of Rituximab in Renal Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Transplantation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Kidney Transplantation Immunosuppression Rituximab

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rituximab

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gunnar E Tydén, Professor

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Transplantation Surgery, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Genberg H, Hansson A, Wernerson A, Wennberg L, Tyden G. Pharmacodynamics of rituximab in kidney allotransplantation. Am J Transplant. 2006 Oct;6(10):2418-28. doi: 10.1111/j.1600-6143.2006.01497.x. Epub 2006 Aug 21.

Reference Type RESULT

PMID: 16925569 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Eudra CT: 2005-001231-29

Identifier Type: -

Identifier Source: org_study_id