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|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|