Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SRM003 · 1 trial · 1 indication
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.
| Arm | Type | Description |
|---|---|---|
| SRM003 | ACTIVE_COMPARATOR | One time implant (2 SRM003 pieces) on surgery day. Post-surgery, up to 26 weeks follow-up for assessment of efficacy/safety. |
| Participating Site's standard practice | OTHER | Subjects will receive sites' standard practice treatment during the surgical procedure. |
| Name | Type | Description |
|---|---|---|
| SRM003 | BIOLOGICAL | One time implant (2 SRM003 pieces) on surgery day. |
| Participating Site's standard practice | OTHER | Subjects will receive sites' standard practice treatment during the surgical procedure. |
Inclusion Criteria: 1. Subject must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female. 2. Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization. 3. Subject must be ...
SRM003 is a monoclonal antibody being studied for use in patients undergoing creation of an arteriovenous fistula to facilitate hemodialysis access. It is intended to treat arteriovenous fistula, a condition related to blood vessel access for dialysis. The drug is currently in Phase 2 clinical development.
SRM003 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody for arteriovenous fistula.
SRM003 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial has been completed to assess its efficacy and safety in patients undergoing arteriovenous fistula creation for hemodialysis access.
SRM003 has one completed Phase 2 clinical trial, identified as NCT01806545. This study evaluated the efficacy and safety of SRM003 in subjects undergoing creation of an arteriovenous fistula to facilitate hemodialysis access. The trial enrolled 64 participants in the United States.
Yes, SRM003 is a monoclonal antibody. It is being investigated as a treatment for arteriovenous fistula in patients requiring hemodialysis access. The drug is in Phase 2 clinical development, with one completed trial involving 64 participants.