A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease
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.
Timeline
- Start
- 2008-08
- Primary completion
- 2014-11
- Completion
- —
Outcome
Missed primary endpoint
Stopped: “Terminated by the DSMB based on low chance of finding differences in mGFR slopes, but higher risk of serious adverse events in the IV iron group (aIRR = 1.60)”
registry analysis (superiority or other test); IV Iron vs Oral Iron; p = 0.79; Mean Difference (Net) -0.35 (95% CI -2.9 to 2.3) NCT00830037 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 325 mg | Oral |
| Subject | Iron sucrose | Unknown | 200 mg | Intravenous |