Safety and Efficacy Study of Rituximab in Renal Transplan... | NCT00255593

Studies
Safety and Efficacy Study of Rituximab in Renal Transplantation

NCT00255593

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Nov 30, 2007Estimated

Enrollment

140Estimated

Phase

Phase 1

Conditions

Renal Transplantation

Interventions

rituximab

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Nov 18, 2005

First Submission Date that Met QC Criteria

Nov 18, 2005

First Posted Date

Nov 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2007

Last Update Posted Date

Nov 30, 2007Estimated

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Name	Type	Description	Arm Group Labels	Other Names
rituximab	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation

Secondary Outcomes

Measure	Description	Time Frame
Renal function at 6 months
Incidence of infections
Incidence of rituximab-related adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunnar E Tydén, Professor	Karolinska Institutet	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Transplantation Surgery, Karolinska University Hospital		Stockholm		141 86	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16925569	Result	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.

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins