TARGTEPO Treatment for Anemia in PD US Trial
Safety & Efficacy of Prolonged Physiologic EPO Level Treatment of Anemia in ESRD Patients Undergoing Peritoneal Dialysis Using MDGN201 TARGTEPO
Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company
Terminated
No statistical analysis was performed as only one subject was treated with MDGN201 TARGTEPO due to the Sponsor's decision to discontinue study.
Listed as NCT02468414, this PHASE2 trial focuses on Anemia of End Stage Renal Disease and remains terminated or withdrawn. Sponsored by Aevi Genomic Medicine, LLC, a Cerecor company, it has been updated 15 times since 2015, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)This is a Phase II, open-label study. Each patient will be administered with a targeted dose of EPO delivered via TARGTEPO.
The targeted doses will be determined according to 2 cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day). The objective is to evaluate safety and biologic activity of TARGTEPO treatment when maintaining Hb levels within the target range of 9-12 g/dl. Biological activity assessments will include duration of TARGTEPO secretion as measured by serum EPO levels above baseline.
This is a Phase II, open-label study. Each patient will be administered with a targeted dose of EPO delivered via TARGTEPO.
The targeted doses will be determined according to 2 cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day). The objective is to evaluate safety and biologic activity of TARGTEPO treatment when maintaining Hb levels within the target range of 9-12 g/dl. Biological activity assessments will include duration of TARGTEPO secretion as measured by serum EPO levels above baseline.
Status Flow
Change History
15 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE2
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Sep 2024 — Present [monthly]
Terminated PHASE2
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Jul 2024 — Sep 2024 [monthly]
Terminated PHASE2
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Jun 2022 — Jul 2024 [monthly]
Terminated PHASE2
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Apr 2022 — Jun 2022 [monthly]
Terminated PHASE2
▶ Show 10 earlier versions
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Dec 2021 — Apr 2022 [monthly]
Terminated PHASE2
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Jan 2021 — Dec 2021 [monthly]
Terminated PHASE2
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Nov 2020 — Jan 2021 [monthly]
Terminated PHASE2
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Jun 2020 — Nov 2020 [monthly]
Terminated PHASE2
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Jun 2018 — Jun 2020 [monthly]
Terminated PHASE2
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May 2018 — Jun 2018 [monthly]
Terminated PHASE2
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Aug 2017 — May 2018 [monthly]
Terminated PHASE2
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Jun 2017 — Aug 2017 [monthly]
Terminated PHASE2
Status: Completed → Terminated
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Feb 2017 — Jun 2017 [monthly]
Completed PHASE2
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Jun 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Aevi Genomic Medicine, LLC, a Cerecor company
- Medgenics Medical Israel Ltd.
For direct contact, visit the study record on ClinicalTrials.gov .