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NCT00830037 · ClinicalTrials.gov registry record · Phase 4
A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease
A Phase 4 study, sponsored by Indiana University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 136
- Enrollment target
NCT00830037: Clinical Trial Phase 4 study, sponsored by Indiana University.
NCT00830037 is a Phase 4 study that was terminated before completion, run by Indiana University. The registered enrollment target is 136 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00830037, a Phase 4 study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 136 participants
- Enrollment target
Study Summary
The long-term goal is to assess the fall in kidney function measured by glomerular filtration rate (GFR) when patients with chronic kidney disease (CKD) are exposed to intravenous iron (IVIR). We hypothesize that in subjects with mild to moderate CKD, infusion of intravenous iron (IVIR), will generate oxidative stress and cause an inflammatory response that will be associated with a more rapid decline in glomerular filtration rate (GFR) compared to oral iron.
Primary Outcome
Plasma clearance of iothalamate was measured by administering an IV bolus of 5 mL of iothalamate meglumine and sampling 2 mL of blood at 0, 5, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, and 300 min after injection. Iothalamate was measured by high-performance liquid chromatography. Plasma clearance was calculated using a two-pool model using validated pharmacokinetic software. The mean modeled iothalamate mGFR slope (e.g., change from baseline to 2 years) in each group (IV iron vs. oral iron) w
Interventions
- DRUG Ferrous Sulfate
- DRUG IV Iron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2008-08 |
| Phase | Phase 4 |
Why NCT00830037 stopped before completion
NCT00830037 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Ferrous Sulfate is the first listed.
NCT00830037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00830037 about?
NCT00830037 is a clinical study titled "A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease". The long-term goal is to assess the fall in kidney function measured by glomerular filtration rate (GFR) when patients with chronic kidney disease (CKD) are exposed to intravenous iron (IVIR). We hypothesize that in subjects with mild to moderate CKD, infusion of intravenous iron (IVIR), will genera...
What is the current status of trial NCT00830037?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 136 participants. The study started on 2008-08.
What interventions are being tested in trial NCT00830037?
The interventions under investigation include: Ferrous Sulfate (DRUG), IV Iron (DRUG).
Who is sponsoring clinical trial NCT00830037?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00830037's enrollment target sits among peer trials
136 596th of 2000 higher than 1,400 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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