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MDGN201 TARGTEPO

Phase 2

Chronic Kidney Disease | Monoclonal antibody | Nephrology |Avalo Therapeutics, Inc.|Trials Updated: Oct 30, 2018

MDGN201 TARGTEPO development status

Highest phase Phase 2 (NCT02468414)
Phase scored for AVTXPhase 1
Registered trials 3 across 1 sponsor since Apr 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

MDGN201 TARGTEPO clinical trials

MDGN201 TARGTEPO · 1 trial · 2 indications

Phase 1 1
NCT02117427TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD)Chronic Kidney Disease
COMPLETED11 Analytics
PHASE1COMPLETED
TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD)
Chronic Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Total EPO Secretion
up to 52 weeks
Percent (%) of Hb Measurements After Implantation Within 9-11 g/dL
52 weeks
Percent (%) of Hb Measurements After Implantation Within 9-12 g/dL
52 weeks

Due to the small sample size and the dispersion of total EPO secretion, the efficacy analyses were performed on all of the patients as a single cohort of intended dose between 25 and 45 U/Kg/d.

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALMDGN201 TARGTEPO secreting EPO (18-25 IU/Kg/day)
Group BEXPERIMENTALMDGN201 TARGTEPO secreting EPO (35-45 IU/Kg/day)
Group CEXPERIMENTALMDGN201 TARGTEPO secreting EPO (55-65 IU/Kg/day)

Interventions

NameTypeDescription
MDGN201 TARGTEPOBIOLOGICALErythropoietin secreted by TARGTEPO transduced with MDGN201
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. For ESRD patients: Subject diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on hemodialysis treatment for at least 6 months. Average Hb during last month between 9 to 12g/dL. 2. Kt/V \>1 3. INR not higher than 1.2 4. Serum albumin \>3.5 5. Subjects with adequate...

Countries:Israel
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Frequently asked questions about MDGN201 TARGTEPO

What is MDGN201 TARGTEPO?

MDGN201 TARGTEPO is an investigational monoclonal antibody developed by Avalo Therapeutics, Inc. (ticker AVTX) for chronic kidney disease. It was studied in a Phase 1 clinical trial evaluating treatment for anemia in patients with chronic kidney disease and end-stage renal disease. The program is in clinical development and is not approved.

What is MDGN201 TARGTEPO used for in chronic kidney disease?

MDGN201 TARGTEPO was studied for the treatment of anemia in patients with chronic kidney disease and end-stage renal disease. The Phase 1 trial enrolled adults aged 18 years and older, including both men and women, in Israel. The study has been completed.

Who makes MDGN201 TARGTEPO?

MDGN201 TARGTEPO is being developed by Avalo Therapeutics, Inc., which trades under the ticker AVTX. Avalo Therapeutics is the sponsor of the clinical program for this monoclonal antibody in chronic kidney disease.

What phase is MDGN201 TARGTEPO in?

MDGN201 TARGTEPO is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved for commercial use. The Phase 1 trial has been completed, and no active trials are currently listed for this program.

What clinical trials is MDGN201 TARGTEPO in?

MDGN201 TARGTEPO was evaluated in one completed Phase 1 trial, NCT02117427, titled TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD). The trial enrolled 11 participants in Israel and used a controlled design without randomization or double blinding.