A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Indiana University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00830037
First received: January 26, 2009
Last updated: September 26, 2014
Last verified: September 2014

January 26, 2009
September 26, 2014
August 2008
August 2015   (final data collection date for primary outcome measure)
Mear rate of decline in GFR in the two groups - oral and IV iron [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00830037 on ClinicalTrials.gov Archive Site
Proteinuria [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Clinical Trial of Oral Versus IV Iron in Patients With Chronic Kidney Disease
Pathobiology of Kidney Disease: Role of Iron

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Iron-deficiency Anemia
  • 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
  • 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.
  • Experimental: IV Iron
    Intervention: Drug: IV Iron
  • Active Comparator: Oral Iron
    Intervention: Drug: Ferrous Sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2015
August 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Maria M Pappas, BS 317-988-4591 pappas2@iu.edu
United States
 
NCT00830037
DK71633, U01DK071633, 5U01DK071633-02
Yes
Indiana University
Indiana University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Rajiv Agarwal, MD FASN FAHA Indiana University
Indiana University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP