REFCTRI/2010/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Mon, 29 Jan :45:50 GMT) CTRI Number CTRI/2010/091/ [Registered on: 21/04/2010] - Last Modified On 26/07/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Interventional Drug Randomized, Parallel Group, Active Controlled Trial A clinical trial to study Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects with Chronic Kidney Disease Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects with Chronic Kidney Disease Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) FER-CKD-201 NCT Other ClinicalTrials.gov Details of Principal Investigator Sr Manager, Clinical Operations Phone Fax fernandezrobert@praintl.com Details Contact Person (Scientific Query) Sr Manager, Clinical Operations Phone Fax fernandezrobert@praintl.com Details Contact Person (Public Query) Sr Manager, Clinical Operationsq Phone page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax > AMAG Pharmaceuticals, Inc. Source of Monetary or Material Support Primary Sponsor Details AMAG Pharmaceuticals Inc 100 Hayden Avenue Lexington, Massachusetts Type of Sponsor NA List of Countries of Principal Investigator Dr. Somasekhar Mudigonda Pharmaceutical industry-global of Site Site Phone/Fax/ Apollo Hospital AHERF Clinical Trials Unit, 1st Floor, AIHA Building,Near Apollo Health Street,Apollo Hospitals,Jubilee Hills Hyderabad ANDHRA PRADESH Dr. Kishore Babu Bangalore Clinisearch No.416, 4th Cross, 2nd block,kalyan Nagar Bangalore KARNATAKA Dr. Mahesh Eswarappa Gokula Metropolis Clinical Research Center Dr. Sonal Dalal Dr. Shriniwas Ambike Dr. Apurva Parekh Gujarat Kidney Foundation Jehangir Clinical Development Centre Pvt Ltd Kidney Disease & Transplant Foundation M.S.Ramaiah Memorial Hospital, MSRIT Post,New BEL Road Bangalore KARNATAKA mssekhar_58@rediffma il.com drkishorebabu@vsnl.ne t manasnephro2002@ya hoo.co.in 4-5th Floor, Shaival complex, Near Suvidha Shopping sonalsanjiv@yahoo.co centre,between Parimal m crossing & Mahalaxmi Char Rasta, Paldi Ahmadabad GUJARAT Jehangir Hospital,32, Sasoon Road Pune drsmambike@yahoo.co.in 4th Floor, Shubham Superspeciality Hospital, Opp. Bank of aparekh.icubecr@gmail Baroda,Near Sardar.com Patel Statue, Sardar Patel Colony,Naranpura Ahmadabad GUJARAT page 2 / 5

3 Details of Ethics Regulatory Clearance Status from DCGI Health Condition / Problems Studied Dr. Alan Fernandes Almeida Dr.Laxmi Chand Sharma Dr. Jugal Bihari Gupta Dr. Prakash Khetan P D Hinduja National Hospital & Medical Research Centre S.M.S Medical College & Hospital S.R. Kalla Memorial Gastro & General Hospital Shravan Hospital and Kidney Institute Veer Savarkar Marg, Mahim Dept. of Nephrology,Sawai Ram Singh Road Jaipur RAJASTHAN 78, Dhuleshwar Garden,Behind HSBC Bank,Sardar Patel Marg,C Scheme ,Nandanvan Main road Nagpur nephro7@gmail.com/al analmeida@vsnl.net laxmi_jp1@sancharnet.i n guptadrjb@rediffmail.co m prakashkhe@gmail.co m of Approval Status Date of Approval Is Independent Ethics? Bangalore Central Central Clinical Research Ethics Ethical Board Ethics committee (SMS Medical College & hospital) Ethics committee, Apollo Hospitals. Gujarat Kidney Foundation Ethics Hirabai Cowarji Jehangir Medical Research Institute & Jehangir Clinical Development Centre National Health & Education Society Clinical Research & SR Kalla Memorial Ethical for Human Research Sujlam Independent Status Approved 19/03/2010 Approved 15/03/2010 Yes Approved 07/04/2010 No Approved 09/03/2010 No Approved 27/03/2010 Yes Date Approved/Obtained 01/04/2010 Health Type Condition page 3 / 5

4 Intervention / Comparator Agent Inclusion Criteria Subjects with Iron Deficiency Anemia and Chronic Kidney Disease Type Details Intervention IV Ferumoxytol IV injection of ferumoxytol 510 mg (17 ml) on Day 1 with a second dose 5±3 days after Dose 1, each administered as a rapid IV injection of 17 ml at a rate not to exceed 1 ml/sec, for a total cumulative dose of 1.02 g Comparator Agent IV Iron Sucrose 200 mg on Day 1 and at 4 other visits on nonconsecutive days over a 14 day period for a total cumulative dose of 1.0 g Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1.Males and females?18 years of age 2.A diagnosis of CKD (eg, nephropathy, nephritis) 3.Hemodialysis subjects on maintenance dialysis for at least three months prior to screening and currently receiving dialysis three times per week 4.Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of the study 5.Subject is capable of understanding and complying with the protocol requirements and is available for the duration of the study 6.Subject has been informed of the investigational nature of this study and has given voluntary written informed consent and, if applicable, Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional, local, and national personal health data protection guidelines Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Stratified randomization Not Applicable Open Label Exclusion Criteria 1.History of allergy to IV iron 2.Allergy to 2 or more classes of drugs 3.Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test 4.Hemoglobin 7.0 g/dl Primary Outcome Outcome Timepoints Mean change in hemoglobin - Secondary Outcome Outcome Timepoints Target Sample Size Not applicable Phase of Trial Phase 2 Date of First Total Sample Size=150 Sample Size from =80 page 4 / 5

5 Powered by TCPDF ( REFCTRI/2010/ Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 10/03/2010 Years= Months=1 Days=19 Completed Other (Terminated) The study is randomized,parralel group active control trial.the purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in subjects with chronic kidney disease (CKD). The efficacy endpoints are: Mean change in hemoglobin The study will be conducted in 10 centers in and its also being conducted in USA 15 Centers, Canada 4 centres, United Kingdom 3 centers, Poland 15 centers, Hungary 3 centers, Germany 7 centers and Belgium 3 centers.globally 150 Patients will be enrolled in the study and from we are expecting to recruit 60 patients Study Discontinuation in : The Sponsor of this study,amag Pharmaceuitcal has decided to discontinue enrollment for this study in & close study activities.this is a strategic decision based on the current global enrollment status of this study.no patients from have been enrolled into this study. page 5 / 5