Recent Updates
Recently added Catalysts

IVIG and Rituximab

Phase 1

Kidney Transplant | Small molecule | Nephrology |Biogen Inc.|Last Updated: Mar 25, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00642655Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal TransplantationPHASE1 COMPLETED 20Sep 1, 2005May 1, 2007Mar 25, 20081 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Success of transplantation
12 months
Secondary Endpoints
Number and severity of rejection episodes
12
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
IVIG and RituximabDRUGIVIG 2gm/kg given intravenously on day#0 and day#30 Rituximab 1gm given intravenously on day#7 and day#22
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients eligible for the study will be those who have anti-HLA antibody (Panel Reactive Antibody \[PRA\]) of \>30% and are eligible for transplantation at Cedars-Sinai Medical Center. We currently anticipate entering 20 patients over the course of the study. We currently have...

Countries:United States
Unlock Eligibility Criteria