| CTRI Number |
CTRI/2010/091/000417 [Registered on: 28/06/2010] |
| Last Modified On: |
18/06/2015 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Research Study to demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is non-inferior to oral iron sulphate in reducing renal related anemia in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD), determined as ability to increase Hb. |
Scientific Title of Study
Modification(s)
|
A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) administered by Infusions or Repeated Bolus Injections in Comparison with Oral Iron Sulphate in Subjects with Non-Dialysis Dependent Chronic Kidney Disease and with Renal-Related Anaemia. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| P-Monofer-CKD-02 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sanjiv Saxena |
| Designation |
Consultant Nephrologist |
| Affiliation |
|
| Address |
Department of Nephrology Pushpawati Singhania Research Institute, Sheikh Sarai, Phase II,
New Delhi-110017, India
New Delhi
DELHI
110017
India |
| Phone |
91-9810139839 |
| Fax |
91-11-29250548 |
| Email |
drsanjivsaxena@rediffmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sanjiv Saxena |
| Designation |
Consultant Nephrologist |
| Affiliation |
|
| Address |
Department of Nephrology Pushpawati Singhania Research Institute, Sheikh Sarai, Phase II,
New Delhi-110017, India
New Delhi
DELHI
110017
India |
| Phone |
91-9810139839 |
| Fax |
91-11-29250548 |
| Email |
drsanjivsaxena@rediffmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shariq Anwar |
| Designation |
Director Operations |
| Affiliation |
|
| Address |
Max Neeman International, Max House, First Floor, 1 Dr. Jha Marg, Okhla Phase - III New Delhi- 110020
phrology
New Delhi
DELHI
110020
India |
| Phone |
91-9810979215 |
| Fax |
91-11-40548168 |
| Email |
Shariq.Anwar@neemanasia.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Pharmacosmos A/S Roervangsvej 30, DK-4300 Holbaek, Denmark |
|
Primary Sponsor
Modification(s)
|
| Name |
Pharmacosmos AS |
| Address |
Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Max Neeman International |
Max Neeman International, Max House, Ground Floor, 1 Dr. Jha Marg, Okhla Phase - III New Delhi- 110020 |
|
Countries of Recruitment
Modification(s)
|
Denmark
India
Sweden
United Kingdom |
Sites of Study
Modification(s)
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajesh Kumar |
Apex Kidney Care Pvt Ltd, |
3rd Floor, Abhishek Commercial Complex,S.V Road, Malad (w)-400064
Mumbai
MAHARASHTRA |
+91- 9821267704
rajkbasudeo@yahoo.com |
| Dr Deepak Dewan |
Ajanta Research Centre, |
Ajanta Hospital and IVF Centre,765-ABC Complex, Near Krishna Cinema, Kanpur Road,Alambagh-226005
Lucknow
UTTAR PRADESH |
919636507362
drdeepakdewan@rediffmail.com |
| Dr Tushar Dighe |
Deenanath Mangeshkar Hospital & Research Centre |
Off Karve Road Erandawane, Pune - 411004, Maharashtra, India
Pune
MAHARASHTRA |
919822052479
drtadighe@yahoo.co.in |
| Dr Manisha Sahay |
Department of Nephrology,Osmania General Hospital |
Afzalgunj,-500012
Hyderabad
ANDHRA PRADESH |
+91-9849097507
drmanishasahay@gmail.com |
| Dr. Dhananjai Agarwal |
Department of Nephrology,SMS Medical College and Hospital, Jawahar Lal Nehru Marg ,Jaipur-302004, India |
SMS Medical College and Hospital,Jawahar Lal Nehru Marg,Jaipur-302004, India -302004
Jaipur
RAJASTHAN |
+91-9414459790
dhananjaynephro@gmail.com |
| Dr. Hargovind Laxmishanker Trivedi |
Dr. Hargovind Laxmishanker Trivedi Institute of Kidney Disease & Research Centre |
Civil Hospital Campus,Asarwa-380016
|
+91-9727722200
+91-79-22682811
ikdrc1@sancharnet.in |
| Dr. Sonal Dalal |
Gujarat Kidney Foundation |
4th Floor Saival Complex,Near Suvidha Shopping Centre, Between Parimal Crossing & Mahalxmi Char Rasta, Paldi-380007
Ahmadabad
GUJARAT |
+91-9825008924
+91-79-26652220
sonalsanjiv@yahoo.com |
| Dr Velagala Satti Reddy |
Krishna Institute of Medical Sciences |
1-8-31/1, Minister Road, Hyderabad-500003, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH |
919848627321
drvsreddynephrology@gmail.com |
| Dr Mahesh Eswarappa |
M S Ramaiah Memorial hospital |
M S Ramaiah Memorial hospital,
New BEL Road,
MSRIT Post, Bengaluru-560054
Karnataka, India
Bangalore
KARNATAKA |
0-80-22183063
0-80-40528402
manasnephro2002@yahoo.co.in |
| Dr NPSingh |
Maulana Azad Medical College & Associated Lok Nayak Hospital |
122, Taneja Block,
New Delhi - 110002
India.
New Delhi
DELHI |
919968604274
nanu_singh@yahoo.com |
| Dr. Ashok Kumar Sharma |
Monilek Hospital & Research Centre |
Sector 4, Jawahar Nagar,,-302 004
Jaipur
RAJASTHAN |
+91-9829065210
+91-141-2652181
draksharma_50@yahoo.com |
| Dr. Jatin Kothari |
P. D. Hinduja National Hospital and Research Center |
Veer Savarkar Marg,Mahim-400016
Mumbai
MAHARASHTRA |
+91- 9820121010
jatin_kothari@yahoo.com |
| Dr. Sanjiv Saxena |
Pushpawati Singhania Research Institute |
Sheikh Sarai II,-110017
New Delhi
DELHI |
+91- 9810139839
drsanjivsaxena@rediffmail.com |
| Dr Veerabhadra Guptha |
Rangadore Memorial Hospital, |
1st Cross, Shankarapuram,
Basavanagudi, Bengaluru
Karnataka, India
Bangalore
KARNATAKA |
919448132374
drkvguptha@gmail.com |
| Dr Alok Jain |
S.K. Soni Hospital |
S.K. Soni Hospital, Jaipur - 302013 India.
Jaipur
RAJASTHAN |
91982969695
drjainalok@gmail.com |
| Dr. Bhavin Mehtalia |
Shubham Super Specialty Hospital |
4th Floor, Kidney Diseases and Transplant Foundation,Narayanpura-380014
Ahmadabad
GUJARAT |
079 3030179517
079 3030179517
bmehtalia@rediffmail.com |
| Dr. Gokulnath |
St.Johns Medical College & Hospital |
Sarjapur Road,-560034
|
+91-80-22065301
+91-80-25633844
gokul_neph@yahoo.co.uk |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| Apex Kidney Care Pvt Ltd, 3rd Floor, Abhishek Commercial Complex, S.V Road, Malad (w), Mumbai |
Approved |
| Bio-Ethics Forum of Lucknow |
Approved |
| Ethical Review Board, M S Ramaiah Medical College and Teaching Hospital-Bengaluru |
Approved |
| Ethiclin Independent Ethics committee, Ahmedabad |
Approved |
| Ethics Committee SMS Medical College-Jaipur |
Approved |
| Gujarat Kidney Foundation Ethical Committee-Ahmedabad |
Approved |
| Institutional Ethical Review Board, Bangalore |
Approved |
| Institutional Ethics Committee, DMH, Pune |
Approved |
| Institutional Ethics Committee, Maulana Azad Medical College & Associated Lok Nayak Hospital,New Delhi |
Approved |
| Institutional Ethics Committee, Monilek Hospital and research Centre- Jaipur |
Approved |
| Institutional Ethics Committee,KIMS, Hyderabad |
Approved |
| Institutional Review Board, Pushpawati Singhania Research Institute for Liver, Renal & Digestive Diseases,-New Delhi |
Approved |
| Internal review Board, IKDRC-ITS- Ahmedabad |
Approved |
| National Health and Society Clinical research and Ethics Committee-Mumbai |
Approved |
| Osmania medical College Ethics Committee-Hyderabad |
Approved |
| Rangadore Memorial Hospital Ethics Committee, Bengaluru |
Approved |
| SEROCH Ethics Committee, Jaipur |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
non-dialysis dependent chronic kidney disease Subjects , |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Iron isomaltoside 1000 (Monofer®) |
1.Administered as intravenous infusions (A1) upto 1000 mg at a time until total iron repletion is obtained 2.Administered as intravenous bolus injections (A2) as repeated bolus injections 500mg weekly until total iron repletion is obtained. |
| Comparator Agent |
Iron Sulphate |
Oral, 100 mg elemental Iron 2 times a day for 8 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Men and women, aged more than 18 years.
2. Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
3. Hb 11.0 g/dL (6.80 mmol/L)
4. Either or both of the following iron stores indicators below target {Serum ferritin < 200 ug/l and Transferrin saturation (TfS)<20%}.
5. Life expectancy beyond 12 months by Principal Investigator?s judgement.
6. Willingness to participate after informed consent and any authorization as required by local law ( e.g. Protected Health Information [PHI] for North America).
|
|
| ExclusionCriteria |
| Details |
1. Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator s? judgment).
2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate or any excipients of the study drug.
4. Subjects with history of multiple allergies.
5. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) > 3 times upper normal limit)
6. Diagnosis of Hepatitis B and/or C confirmed by appropriate lab test.
7. Active acute or chronic infections ((assessed by clinical judgment), supplied with white blood cells (WBC) and C-reactive protein (CRP)).
8. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
9. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product (5 days): Contraceptive pills, Intrauterine Devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
10. Extensive active bleeding necessitating blood transfusion.
11. Planned elective surgery during the study.
12. Participation in any other clinical study within 3 months prior to screening.
13. Known intolerance to oral iron treatment.
14. Untreated B12 or folate deficiency.
15. I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
16. ESA treatment within 8 weeks prior to screening visit.
17. Serum ferritin > 500 μg/L.
18. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study or interfere with study drug evaluation. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
19. History of immunodeficiency, including positive HIV test result.
20. Body weight < 30 kilograms |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
On-site computer system |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Intravenous iron isomaltoside 1000 (Monofer®) is non-inferior to oral iron sulphate in reducing renal related anemia in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD), determined as ability to increase Hb. |
Wk 1, 2, 3, 4, and 8 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. To assess other relevant haematology and biochemical parameters during the study.
2. Quality of Life assessment (QoL) by Linear Analog Scale Assessment (LASA).
3. To assess safety of intravenous iron isomaltoside 1000 (Monofer®) compared to oral iron sulfate.
4. Assessment of RLS symptoms and change in these symptoms during the study.
|
Time Points: Wk 1, 2, 3, 4, and 8 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="350"
Sample Size from India="202"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
09/07/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/09/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none as yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Study Design: Prospective, Open-label, Randomized, Comparative, Multi-centre Study with Two Treatment Groups: A. Iron isomaltoside 1000 (Monofer®) - Administered as intravenous infusions (A1) · Maximum 1000 mg iron each week until full replacement dose is achieved (if the subject weight is between 35.1-45 kg maximum 750 mg iron/infusion or if the subject weight is between 30-35 kg maximum 500 mg iron/infusion). · The infusion is diluted in 100 mL 0.9% sodium chloride and given over approximately 15 minutes. - Administered as intravenous bolus injections (A2) · The full iron replacement dose of iron isomaltoside 1000 (Monofer®) listed in the dosing table is administered as bolus injections of 500 mg administered undiluted over approximately 2 minutes, once per week until full replacement dose is achieved. · In some cases the remaining dose on the last dosing day may be 250 mg e.g., on visit 4 if the full replacement dose is 1250mg, · In these situations remaining 250 mg should be administered undiluted over approximately 2 minutes -Iron sulphate administered orally (B) · 100 mg elementary iron b.i.d. (200 mg daily) for 8 weeks. Prohibited concomitant medication and therapy: 1. Blood transfusion. 2. Any iron supplementation other than investigational drugs. 3. Erythropoeisis-Stimulating Agents (ESA). 4. Medications which potentially yield a decrease in oral iron absorption, e.g. tetracycline, antacids, cholestyramine etc. |