Clinical Trial Details
| Trial ID: | L0992 |
| Source ID: | NCT00830037 |
| Associated Drug: | Iv Iron |
| Title: | A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00830037/results |
| Conditions: | Chronic Kidney Disease|Iron-deficiency Anemia |
| Interventions: | DRUG: IV Iron|DRUG: Ferrous Sulfate |
| Outcome Measures: | Primary: Mean Rate of Decline in mGFR in the Two Groups - Oral and IV Iron, 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., Baseline, 2 years | Secondary: Proteinuria, 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., Baseline, 2 years |
| Sponsor/Collaborators: | Sponsor: Indiana University | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 136 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2008-08 |
| Completion Date: | |
| Results First Posted: | 2016-07-21 |
| Last Update Posted: | 2016-07-21 |
| Locations: | VA Medical Center, Indianapolis, Indiana, 46202, United States |
| URL: | https://clinicaltrials.gov/show/NCT00830037 |
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