Clinical trial NCT02453334
Conditions: Cancer and Chemotherapy Related Anemia
Sponsor: American Regent, Inc.
Start date: 2015-05-23; Completion date: 2018-01-04
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.

Detailed description:
This is a Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study. Subjects who meet all inclusion criteria and no exclusion criteria, will be randomized into the trial (Group A or B).

Arms: arm 1: 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. arm 2: Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.
Interventions: intervention 1: Injectafer intervention 2: Normal Saline
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_000.pdf: 
NCT02453334 
ID: 1VIT14039   
IRON CLAD: Can Iron Lessen 
Anemia Due to Cancer and 
Chemotherapy: A Study to 
Investigate the Efficacy and 
Safety of Injectafer® 


Luitpold Pharmaceuticals, Inc. 
CONFIDENTIAL 
Protocol: I VIT14039 
Amendment 1,2 and Administrative Amendment I: 02 November 2017 
LUITPOLD PHARMACEUTICALS, INC. 
PROTOCOL 
No. 1VIT14039 
IND# 63,243 
IRON CLAD: Can Iron Lessen Anemia Due to cancer and chemotherapy: A multi­
center, randomized, double-blinded, controlled study to investigate the efficacy and 
safety of lnjectafer® (ferric carboxymaltose injection) in adults 
SPONSOR 
Luitpold Pharmaceuticals, Inc. 
Clinical Research and Development 
800 Adams Ave 
Norristown, PA 19403 
(610) 650-4200
Protocol Date: 04 November 2014 
Amendment 1 Date: 18 February 2015 
Amendment 2 Date: 20 December 2016 
Administrative Amendment 1 Date: 02 November 2017 
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Luitpold Pharmaceuticals, Inc. 
CONFIDENTIAL 
Protocol: I VIT 14039 
Amendment 1,2 and Administrative Amendment I: 02 November 2017 
performed regardless of whether the participant has completed study drug treatment. In 
the event the participant has received any study drug; the participant should be 
contacted for follow-up 30 days after the last dose to assess adverse events, if possible. 
4.5 
Non-Study Intervention 
Non-study intervention is defined as any of the following: 
•
Initiation of erythropoietin for any reason, and/or
•
RBC transfusion, and/or
•
IV iron, and/or
•
Prescribed use of oral iron
When non-study intervention occurs, the date of the intervening event should be 
recorded in the source documents as well as the eCRF, and the participant should 
continue in the study as scheduled. 
5 
STUDY DRUG 
5.1 
Formulation Packaging and Storage 
All medication to be used in this study that has been supplied by luitpold 
Pharmaceuticals, Inc. will have been prepared according to Good Manufacturing 
Practices (GMP). 
FCM will be supplied as 15 ml vials, containing 750 mg of iron as 5% w/v iron 
containing a polynuclear iron(llI)-hydroxide 4(R)-(poly-(1-->4)-O a -D-glucopyranosyl)­
oxy-2 (R), 3(S), 5(R), 6-tetrahydroxy-hexonate complex in a solution of water for 
injection (50 mg/ml) and will be labeled according to FDA investigational regulatory 
requirements. 
Placebo (normal saline) will not be supplied but it must be stored under labeled storage 
conditions. 
All IV study drugs supplied by luitpold Pharmaceuticals, Inc. must be kept in a secure 
place at the investigational site, and stored at room temperature. Refer to the United 
States Pharmacopeia (USP)). The study medication should not be frozen. Vials may 
not be used for more than 1 dose or for more than 1 participant. All FCM vials 
(used and unused) should be kept by the study staff and returned to Luitpold 
Pharmaceuticals, Inc., after drug accountability has been completed by the 
monitor. 
5.2 Drug Administration/Regimen 
Prior to each drug administration participants must be blinded with a sleeping mask, or 
other method. The lnvestigator(s) who is conducting the efficacy and safety evaluations 
will not be present when the study drug is administered to the participant. 
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Luitpold Pharmaceuticals, Inc. 
CONFIDENTIAL 
Statistics 
8.5.2 
#11 
Original Wording 
New Wording 
APPENDIX C: 
Protocol: I VITI 4039 
Amendment 1,2 and Administrative Amendment 1: 02 November2017 
Adverse Events 
SUMMARY OF CHANGES from Protocol Amendment 2 dated 20 December 2016 
to Administrative amendment 1 dated 2 November 2017 
Title of the study 
Original Wording 
IRON CLAD: Can Iron Lessen Anemia Due to cancer 
and chemotherapy: A multi-center, randomized, double-
blinded, controlled study to investigate the efficacy and 
safety of lnjectafer® (ferric carboxymaltose injection). 
New Wording 
IRON CLAD: Can Iron Lessen Anemia Due to cancer 
and chemotherapy: A multi-center, randomized, double-
blinded, controlled study to investigate the efficacy and 
safety of lnjectafer® (ferric carboxymaltose injection) in 
adults 
Signatures of Agreement 
for Protocol 
Original Wording 
New Wording 
Original Wording 
New Wording 
Original Wording 
New Wording 
Sumita Chowdhury, MD, MPH 
Senior Medical Director, Head of Clinical Research and 
Development 
Patricia Campbell, RN 
Manager, Pharmacoviqilance 
Mark Falone, MD, 
Medical Director, 
Head of Clinical Research and Development 
Luitpold Pharmaceuticals, Inc 
Patricia Campbell, RN 
Manager, Pharmacovigilance 
Luitpold Pharmaceuticals, Inc 
Susan Oskins, RN, BSN 
Pharmacovigilance Sr. Manager 
Luitpold Pharmaceuticals, Inc. 
David Morris, PhD 
Senior Director, Statistics 
WebbWrites, LLC 
Nicole Blackman, PhD
Statistician 
Luitpold Pharmaceuticals, Inc. 
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Luitpold Pharmaceuticals, Inc. 
CONFIDENTIAL 
Oriqinal Wordinq 
New Wording 
Original Wording 
New Wording 
Original Wording 
New Wording 
Original Wording 
New Wordinq 
Oriqinal Wordinq 
New Wordinq 
Oriqinal Wordinq 
New Wording 
Font of the document 
Original Wording 
New Wording 
Protocol Date 
Original Wording 
New Wording 
Header 
Original Wording 
New Wording 
STUDY SYNOPSIS 
Original Wordinq 
NewWordinq 
Exclusion Criteria 
Original Wording 
Protocol: 1 VITl4039 
Amendment 1,2 and Administrative Amendment I: 02 November 2017 
International Conference on Harmonisation 
International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for 
Human Use (ICH), ICH 
US Regulations 
FDA Regulations 
Informed Consent 
informed consent 
Study monitor 
Clinical Monitor 
institution 
Institution 
treatment-emergent adverse events 
treatment-emergent adverse events (TEAEs), TEAEs 
Times New Roman 
Arial 
Protocol Date: 04 November 2014 
Amendment 1 Date: 18 February 2015 
Amendment 2 Date: 20 December 2016 
Protocol Date: 04 November 2014 
Amendment 1 Date: 18 February 2015 
Amendment 2 Date: 20 December 2016 
Administrative Amendment 1 Date: 2 November2017 
Luitpold Pharmaceuticals, Inc. 
1VIT14039 
CONFIDENTIAL 
Amendment 2: 20 December 2016 
Luitpold Pharmaceuticals, Inc. 
Protocol: 1VIT14039 
CONFIDENTIAL 
Amendment 1,2 and 
Administrative Amendment 1: 2 November 2017 
Patients 
Participants 
Any anemia treatment within 4 weeks before inclusion 
(oral iron, intravenous iron, transfusion, or 
erythropoiesis-stimulating agents) 
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SAP_001.pdf: 
NCT02453334 
ID: 1VIT14039   
IRON CLAD: Can Iron Lessen 
Anemia Due to Cancer and 
Chemotherapy: A Study to 
Investigate the Efficacy and 
Safety of Injectafer® 


Sponsor: Luitpold Pharmaceuticals, Inc. 
Protocol No: 1 VIT14039 Administrative Amendment 1 
Statistical Analysis Plan 
Statistical Analysis Plan 
Protocol No.: 1VIT14039 
IRON CLAD: Can Iron Lessen Anemia Due to cancer and 
chemotherapy: A multi-center, randomized, double-blinded, 
controlled study to investigate the efficacy and safety of Injectafer® 
(ferric carboxymaltose injection) in adults 
Sponsor: 
Luitpold Pharmaceuticals, Inc. 
Version: 
Version Final 1.0 
Issue Date: 
January 03, 2018 
Version: Final 1.0 (03-January-2018) 
Confidential 
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