A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease - Full Text View

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00830037

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 IV

MedlinePlus related topics: Anemia

Drug Information available for: Ferrous sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pathobiology of Kidney Disease: Role of Iron

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Mear rate of decline in GFR in the two groups - oral and IV iron [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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
IV Iron: Experimental	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.
Oral Iron: Active Comparator	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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830037

Contacts

Contact: Jennifer E Bills, BS	317-988-4692	jebills@iupui.edu
Contact: Robert P Light		lightr@iupui.edu

Locations

United States, Indiana
VA Medical Center	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jenniger E Bills, BS 317-988-4692 jebills@iupui.edu
Contact: Robert Light lightr@iupui.edu

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Rajiv Agarwal, MD, FASN, FAHA

Indiana University

More Information

No publications provided

Responsible Party:	Indiana University ( Rajiv Agarwal, MD )
Study ID Numbers:	DK71633, 5U01DK071633-02
Study First Received:	January 26, 2009
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00830037 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

anemia
iron
kidney disease
progression
glomerular filtration rate

Study placed in the following topic categories:

Renal Insufficiency
Metabolic Diseases
Hematologic Diseases
Kidney Failure, Chronic
Anemia
Disease Progression
Trace Elements
Iron Metabolism Disorders
Anemia, Iron-Deficiency

Ferric oxide, saccharated
Urologic Diseases
Renal Insufficiency, Chronic
Ferrous gluconate
Micronutrients
Kidney Diseases
Iron
Metabolic Disorder
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Metabolic Diseases
Hematologic Diseases
Growth Substances
Physiological Effects of Drugs
Kidney Failure, Chronic
Anemia, Hypochromic
Anemia
Trace Elements

Iron Metabolism Disorders
Pharmacologic Actions
Anemia, Iron-Deficiency
Urologic Diseases
Renal Insufficiency, Chronic
Micronutrients
Kidney Diseases
Iron
Kidney Failure

ClinicalTrials.gov processed this record on May 06, 2009