Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)

NCT02962648 · View on ClinicalTrials.gov ↗

Study Summary

Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.

Interventions

  • DRUG Iron isomaltoside/ferric derisomaltose

Study Locations (20)

Florida

  • Pharmacosmos Investigational Site — Doral
  • Pharmacosmos Investigational Site — Hialeah
  • Pharmacosmos Investigational Site — Miami
  • Pharmacosmos Investigational Site — Miami
  • Pharmacosmos Investigational Site — Miami
  • Pharmacosmos Investigational Site — Miami Lakes
  • Pharmacosmos Investigational Site — West Palm Beach

California

  • Pharmacosmos Investigational Site — Chula Vista
  • Pharmacosmos Investigational Site 1 — La Mesa
  • Pharmacosmos Investigational Site 2 — La Mesa
  • Pharmacosmos Investigational Site — Northridge
  • Pharmacosmos Investigational Site — Porterville

Louisiana

  • Pharmacosmos Investigational Site — Baton Rouge
  • Pharmacosmos Investigational Site — Metairie
  • Pharmacosmos Investigational Site — New Orleans
  • Pharmacosmos Investigational Site — Shreveport

New Jersey

  • Pharmacosmos Investigational Site — Plainsboro

New Mexico

  • Pharmacosmos Investigational Site — Albuquerque

Tennessee

  • Pharmacosmos Investigational Site — Chattanooga

Texas

  • Pharmacosmos Investigational Site — Houston

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2017-01-09
Est. Completion 2018-06-12
Phase Phase 3

Sponsor

Pharmacosmos A/S

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02962648

The ClinicalTrials.gov registry entry for NCT02962648 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharmacosmos A/S, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Iron Deficiency Anemia appearing as the primary indexed condition, and to 1 intervention — of which Iron isomaltoside/ferric derisomaltose is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02962648 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02962648 about?

NCT02962648 is a clinical study titled "An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)". Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.

What is the current status of trial NCT02962648?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 103 participants. The study started on 2017-01-09. Estimated completion is 2018-06-12.

What conditions does trial NCT02962648 study?

This clinical trial studies the following conditions: Iron Deficiency Anemia, Iron Deficiency Anaemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02962648?

The interventions under investigation include: Iron isomaltoside/ferric derisomaltose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02962648?

This trial is sponsored by Pharmacosmos A/S, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02962648 being conducted?

This trial has 20 study locations across California, Florida, Louisiana, New Jersey, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial