Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00994318 · ClinicalTrials.gov registry record · Phase 3
Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
A Phase 3 study, sponsored by Vifor Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 626
- Enrollment target
NCT00994318: Completed Phase 3 study, sponsored by Vifor Pharma.
NCT00994318 is a Phase 3 study that has completed, run by Vifor Pharma. The registered enrollment target is 626 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00994318, a Phase 3 study, has completed, sponsored by Vifor Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 626 participants
- Enrollment target
Study Summary
Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).
Primary Outcome
Endpoint reported number of participants with/without events and was reached: * First time of initiation of additional or alternative anaemia management, * First time the subject reached the Hb trigger. 3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order: 1. FCM (high ferritin target) compared with oral iron. 2. FCM (high ferritin target) compared with FCM (low ferritin target). 3. FCM
Interventions
- DRUG FCM (Ferric carboxymaltose) high ferritin target
- DRUG FCM (Ferric carboxymaltose) low ferritin target
- DRUG Oral Iron (Ferrous sulphate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 626 participants |
| Start Date | 2009-12 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT00994318 record still lists
NCT00994318 is an interventional study that assigns participants to a tested intervention. The registered 626 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 3 interventions - of which FCM (Ferric carboxymaltose) high ferritin target is the first listed.
NCT00994318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00994318 about?
NCT00994318 is a clinical study titled "Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)". Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).
What is the current status of trial NCT00994318?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 626 participants. The study started on 2009-12. Estimated completion is 2014-02.
What interventions are being tested in trial NCT00994318?
The interventions under investigation include: FCM (Ferric carboxymaltose) high ferritin target (DRUG), FCM (Ferric carboxymaltose) low ferritin target (DRUG), Oral Iron (Ferrous sulphate) (DRUG).
Who is sponsoring clinical trial NCT00994318?
This trial is sponsored by Vifor Pharma, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00994318's enrollment target sits among peer trials
626 586th of 2000 higher than 1,415 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06040827 · 626 participants
A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
- NCT05349227 · 625 participants · NA
Comprehensive Outcomes for After Cancer Health
- NCT06103864 · 625 participants · Phase 3
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
- NCT06230510 · 625 participants · NA
Milk-Tot Study: Impact of Whole Versus Low-fat Milk on Child Health
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia