Prospective Observational Study of Erythropoietin-Iron Interaction in Anemia of Renal Disease
Computational Approach to Personalized Anemia Management
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Listed as NCT01719146, this observational or N/A phase trial focuses on Anemia of End Stage Renal Disease and remains completed. Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), it has been updated 16 times since 2013, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)Data will be collected from 120 subjects undergoing hemodialysis treatment at 3 clinical sites across United States (40 per site).5.5 mL blood specimen will be drawn during midweek treatment (Wed/Thu) to measure:
Hemoglobin Concentration Hematocrit Red Blood Cell Count Platelet Count Reticulocyte Percentage Reticulocyte Hemoglobin Mean Cellular Hemoglobin Mean Cellular Hemoglobin Concentration Mean Cell Volume Red Cell Volume Distribution Width Mean Platelet Volume Serum Iron Serum Ferritin Transferrin Saturation Hepcidin Soluble Transferrin Receptor
Weekly ESA and Iron dose delivered will also be recorded.
From these data:
1. a mathematical model will be established to find biomarkers most descriptive with respect to erythropoiesis-iron synergy,
2. a mathematical model will be established to correlate iron dose with iron markers.
Data will be collected from 120 subjects undergoing hemodialysis treatment at 3 clinical sites across United States (40 per site).5.5 mL blood specimen will be drawn during midweek treatment (Wed/Thu) to measure:
Hemoglobin Concentration Hematocrit Red Blood Cell Count Platelet Count Reticulocyte Percentage Reticulocyte Hemoglobin Mean Cellular Hemoglobin Mean Cellular Hemoglobin Concentration Mean Cell Volume Red Cell Volume Distribution Width Mean Platelet Volume Serum Iron Serum Ferritin Transferrin Saturation Hepcidin Soluble Transferrin Receptor
Weekly ESA and Iron dose delivered will also be recorded.
From these data:
1. a mathematical model will be established to find biomarkers most descriptive with respect to erythropoiesis-iron synergy, 2. a mathematical model will be established to correlate iron dose with iron markers.
Status Flow
Change History
16 versions recorded-
Sep 2024 — Present [monthly]
Completed
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Jul 2024 — Sep 2024 [monthly]
Completed
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Nov 2022 — Jul 2024 [monthly]
Completed
Status: Active Not Recruiting → Completed
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Dec 2021 — Nov 2022 [monthly]
Active Not Recruiting
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Sep 2021 — Dec 2021 [monthly]
Active Not Recruiting
▶ Show 11 earlier versions
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Jun 2021 — Sep 2021 [monthly]
Active Not Recruiting
-
Jan 2021 — Jun 2021 [monthly]
Active Not Recruiting
-
Nov 2020 — Jan 2021 [monthly]
Active Not Recruiting
-
Apr 2020 — Nov 2020 [monthly]
Active Not Recruiting
-
May 2019 — Apr 2020 [monthly]
Active Not Recruiting
-
Jun 2018 — May 2019 [monthly]
Active Not Recruiting
-
May 2018 — Jun 2018 [monthly]
Active Not Recruiting
-
Apr 2018 — May 2018 [monthly]
Active Not Recruiting
Phase: NA → None
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Aug 2017 — Apr 2018 [monthly]
Active Not Recruiting NA
-
Feb 2017 — Aug 2017 [monthly]
Active Not Recruiting NA
-
Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting NA
First recorded
Jan 2013
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- University of Louisville
For direct contact, visit the study record on ClinicalTrials.gov .