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NCT02962648 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Iron Deficiency Anemia and Iron Deficiency Anaemia, sponsored by Pharmacosmos A/S.

Completed
Registry status
Phase 3
Development phase
103
Enrollment target
20
Study locations

NCT02962648: Completed Phase 3 study of Iron Deficiency Anemia and Iron Deficiency Anaemia, sponsored by Pharmacosmos A/S.

NCT02962648 is a Phase 3 study of Iron Deficiency Anemia and Iron Deficiency Anaemia that has completed, run by Pharmacosmos A/S. The registered enrollment target is 103 participants, below the 189-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02962648, a Phase 3 study of Iron Deficiency Anemia and Iron Deficiency Anaemia, has completed, sponsored by Pharmacosmos A/S.

COMPLETED
Registry status
Phase 3
Development phase
103 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Safety Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product.

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
Pharmacosmos A/S

10 total trials

What the finished NCT02962648 record still lists

NCT02962648 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 189-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (46% lower).

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.

NCT02962648 names 20 study sites across 7 states, led by Florida, California, Louisiana.

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.

What interventions are being tested in trial NCT02962648?

The interventions under investigation include: Iron isomaltoside/ferric derisomaltose (DRUG).

Who is sponsoring clinical trial NCT02962648?

This trial is sponsored by Pharmacosmos A/S, which has 10 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Iron Deficiency Anemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02962648's enrollment target sits among peer trials

103 11th of 24 higher than 14 of 24 other Iron Deficiency Anemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Iron Deficiency Anemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02962648, the US trial registry maintained by the National Library of Medicine. NCT02962648 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.