A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease
|ClinicalTrials.gov Identifier: NCT00830037|
Recruitment Status : Terminated (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))
First Posted : January 27, 2009
Results First Posted : July 21, 2016
Last Update Posted : July 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Iron-deficiency Anemia||Drug: IV Iron Drug: Ferrous Sulfate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pathobiology of Kidney Disease: Role of Iron|
|Study Start Date :||August 2008|
|Primary Completion Date :||November 2014|
|Experimental: IV Iron||
Drug: IV Iron
IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
Other Name: Venofer
|Active Comparator: Oral Iron||
Drug: Ferrous Sulfate
Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
- Mean Rate of Decline in mGFR in the Two Groups - Oral and IV Iron [ Time Frame: Baseline, 2 years ]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) was then calculated after adjustment for baseline log urinary protein/creatinine ratio.
- Proteinuria [ Time Frame: Baseline, 2 years ]Proteinuria was estimated using measurements of urinary protein and creatinine before iron administration at baseline and at periodic intervals thereafter. Mean change from baseline log urinary protein/creatinine ratio (g/g) is reported at 2 years.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830037
|United States, Indiana|
|VA Medical Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Rajiv Agarwal, MD FASN FAHA||Indiana University|