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

This study has been 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))
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00830037
First received: January 26, 2009
Last updated: June 9, 2016
Last verified: June 2016
Results First Received: April 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Kidney Disease
Iron-deficiency Anemia
Interventions: Drug: IV Iron
Drug: Ferrous Sulfate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
IV Iron 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 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.

Participant Flow:   Overall Study
    IV Iron     Oral Iron  
STARTED     67     69  
COMPLETED     49     50  
NOT COMPLETED     18     19  
Withdrawal by Subject                 2                 3  
Lost to Follow-up                 1                 2  
Active when terminated by DSMB                 15                 14  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
IV Iron 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 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.
Total Total of all reporting groups

Baseline Measures
    IV Iron     Oral Iron     Total  
Number of Participants  
[units: participants]
  67     69     136  
Age  
[units: years]
Mean (Standard Deviation)
  63.2  (10.7)     67.8  (11.5)     65.5  (11.3)  
Gender  
[units: participants]
     
Female     17     15     32  
Male     50     54     104  
Race/Ethnicity, Customized  
[units: participants]
     
Black     27     18     45  
Hispanic     2     0     2  
White     38     51     89  
eGFR [1]
[units: ml/min per 1.73m2]
Mean (Standard Deviation)
  34.3  (10.2)     34.7  (10.0)     34.5  (10.0)  
Proteinuria [2]
[units: participants]
     
High proteinuria stratum (≥3g/g)     9     9     18  
Low proteinuria stratum (<3g/g)     58     60     118  
[1] Estimated GFR by the four-component MDRD (Modification of Diet in Renal Disease) formula
[2] Proteinuria was estimated using measurements of urinary protein and creatinine before iron administration at baseline



  Outcome Measures
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1.  Primary:   Mean Rate of Decline in mGFR in the Two Groups - Oral and IV Iron   [ Time Frame: Baseline, 2 years ]

2.  Secondary:   Proteinuria   [ Time Frame: Baseline, 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rajiv Agarwal, MD, FAHA, FASN, FASH
Organization: Indiana University School of Medicine & Richard L Roudebush VA Medical Center
phone: 317-988-2241
e-mail: ragarwal@iu.edu



Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00830037     History of Changes
Other Study ID Numbers: DK71633
U01DK071633 ( US NIH Grant/Contract Award Number )
5U01DK071633-02 ( US NIH Grant/Contract Award Number )
Study First Received: January 26, 2009
Results First Received: April 28, 2016
Last Updated: June 9, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration