A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease Iron-deficiency Anemia |
Drug: IV Iron Drug: Ferrous Sulfate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pathobiology of Kidney Disease: Role of Iron |
- Mear rate of decline in GFR in the two groups - oral and IV iron [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Proteinuria [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 gluconate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
|
Detailed Description:
Intravenous iron is commonly utilized and is likely a mechanism of renal injury in patients with CKD. This proposal will provide translational data on the role of intravenous iron to progression of kidney disease in patients with CKD. Comparison of IV iron with oral iron will allow testing the hypothesis that IVIR will generate an inflammatory response and albuminuria in the short-term, that will directly lead to a greater rate of fall in GFR, in the long-term, compared to oral iron. We hypothesize that after administration of one gram of IV iron over a course of 8 weeks, renal injury as documented by albuminuria (and fall in GFR) will be increased with IV iron sucrose therapy compared to those randomized to oral iron therapy. A randomized, parallel group, controlled trial will be performed. GFR will be measures every 6 months for two years in 200 participants by iothalamate clearances.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age greater than 18 years
- Calculated GFR by MDRD formula < or = 60ml/min/1.73m2. We will use the MDRD formula that incorporates serum creatinine, age, race and sex, but not albumin, and blood urea nitrogen.
- Presence of anemia and iron deficiency. Anemia will be defined as blood hemoglobin concentration <12g/dL and iron deficiency will be defined using National Kidney Foundation/Kidney Disease Outcome Quality Initiative (NFK-K/DOQI) Guidelines as serum ferritin concentration of <100ng/mL or serum transferrin saturation of <25%.
Exclusion Criteria:
- Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives, condoms, and diaphragms will be considered reliable).
- Known hypersensitivity to iron sucrose (Venofer), iothalamate meglumine (Conray 60, Mallinckrodt) or iodine.
- Anemia that requires RBD transfusion (Hgb <8g/dL) or may potentially need transfusion (active gastrointestinal bleeding). It would be unsafe to withdraw 150 mL blood over the study in such anemic patients.
- Presence of acute renal failure defined as an increase in the baseline serum creatinine concentration of 0.5 mg/dl over 48 hours. This would produce oxidative stress by itself, may give unreliable rate of decline in renal function and may confound results.
- History of IVIR use within 1 month of the study (may confound results of the study if the baseline oxidative stress is increased).
- Evidence of iron overload (serum ferritin >800ng/nl or transferrin saturation >50%)
- Anemia not caused by iron deficiency eg. sickle cell anemia.
- Surgery or systemic or urinary tract infection within 1 month.
- Organ transplant recipient or therapy with immunosuppressive agents. Nasal or inhaled corticosteroids will be permitted.
Contacts and Locations| Contact: Lauren M Baker, BS | 317-988-4316 | bakerlam@iupui.edu |
| United States, Indiana | |
| VA Medical Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Lauren M Baker, BS 317-988-4316 bakerlam@iupui.edu | |
| Principal Investigator: | Rajiv Agarwal, MD FASN FAHA | Indiana University |
More Information
No publications provided
| Responsible Party: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00830037 History of Changes |
| Other Study ID Numbers: | DK71633, U01DK071633, 5U01DK071633-02 |
| Study First Received: | January 26, 2009 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Indiana University:
|
anemia iron kidney disease progression glomerular filtration rate |
Additional relevant MeSH terms:
|
Anemia Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Deficiency Diseases Anemia, Iron-Deficiency Hematologic Diseases Urologic Diseases Renal Insufficiency Malnutrition |
Nutrition Disorders Anemia, Hypochromic Iron Metabolism Disorders Metabolic Diseases Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 18, 2012
