| CTRI Number |
CTRI/2011/03/001655 [Registered on: 31/03/2011] Trial Registered Prospectively |
| Last Modified On: |
13/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
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A clinical trial to compare two drugs Novel Erythropoiesis Stimulating Protein (NESP) and Recombinant Human Erythropoietin (r-HuEPO) for the treatment of low blood hemoglobin concentration in patients with chronic kidney failure Receiving HemoDialysis. |
Scientific Title of Study
Modification(s)
|
A Randomized, Open-Label, Two-Arm, multicentric, Phase III Comparative Study between Novel Erythropoiesis Stimulating Protein (NESP) and Recombinant Human Eythropoietin (r-HuEPO) for Treatment of Renal Anaemia in Patients with Chronic Renal Failure (CRF) Receiving HemoDialysis. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| KHK-NESP-III-0709 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Desai |
| Designation |
Associate Director, Clinical Project Management |
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
Associate Director, Clinical Project Management
SIRO Clinpharm Pvt. Ltd.
DIL Complex, Second Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road.
Thane
MAHARASHTRA
400 610
India |
| Phone |
022-2584-8000 |
| Fax |
022-2584-8275 |
| Email |
shubhangi.desai@siroclinpharm.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shubhangi Desai |
| Designation |
Head Clinical Operations - Asia Pacific |
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
SIRO Clinpharm Pvt. Ltd.
DIL Complex, Second Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road
Thane
MAHARASHTRA
400 610
India |
| Phone |
022-25848000 |
| Fax |
022-25848275 |
| Email |
shubhangi.desai@siroclinpharm.com |
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Source of Monetary or Material Support
Modification(s)
|
| Kyowa Hakko Kirin Co. Ltd
1-6-1, Ohtemachi, Chiyoda-Ku
Tokyo, 100-8185, Japan |
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Primary Sponsor
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| Name |
Kyowa Hakko Kirin Co Ltd |
| Address |
1-6-1, Ohtemachi, Chiyoda-Ku
Tokyo, 100-8185, Japan |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| SIRO Clinpharm Pvt Ltd |
DIL Complex, Second Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road, Thane - 400 610.
Maharashtra |
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrGeorge Kurian |
Amrita Institute of Medical Sciences (AIMS) |
Amrita Cancer Institute,
Amrita Lane, Elamakkara Post,
Kochi, Kerala
Pincode: 682 026
Ernakulam
KERALA |
91-9447793625
georgekurian@aims.amrita.edu |
| Dr Rajesh Kumar |
Apex Kidney Care Pvt. Ltd |
Apex Kidney Care Pvt. Ltd.,
3rd floor, Abhishek Commercial Complex
S.V.Road, Malad (W)
Mumbai- 400 064
Mumbai
MAHARASHTRA |
02228809114
rajkbasudeo@yahoo.com |
| Dr Mahesh |
Chaya Hospital |
4th C Main Road, 6th Cross, OMBR Layout, Banaswadi, Bangalore- 560 043
Bangalore
KARNATAKA |
08025426030
doccm2000@yahoo.com |
| Dr Sanjiv Jasuja |
Indraprastha Apollo Hospital |
Sarita Vihar, Delhi Mathura Road
New Delhi- 110076
New Delhi
DELHI |
01126925858
sanjivjasuja@yahoo.com |
| DrHLTrivedi |
Institute of Kidney Diseases and Research Centre (IKRDC)-Institute of Transplantation Sciences (ITS) |
Civil Hospital Campus, Asarwa,
Ahmedabad, Gujarat – 380 016
Ahmadabad
GUJARAT |
91-9825010184
ikdrcad1@sancharnet.in |
| DrMM Bahadur |
Jaslok Hospital and Research Centre |
Jaslok Hospital and Research Centre-15
Dr.G. Deshmukh Marg
Mumbai- 400 026
Mumbai
MAHARASHTRA |
02266573333
madanbahadur@gmail.com |
| Dr Satish Balan |
Kerala Institute of Medical Sciences (KIMS) |
Annayara P.O, Anamukham,
Trivandrum-695 029
Thiruvananthapuram
KERALA |
91-9447165591
balansatish@rediffmail.com |
| Dr Apoorva Parekh |
Kidney Diseases and Transplant Foundation |
Kidney Diseases and Transplant Foundation,
c/o Shubham Superspeciality Hospital
Opp. Bank of Baroda, Near Sardar Patel Statue, Sardar Patel Colony, Naranpura, Ahmedabad- 380 013
Ahmadabad
GUJARAT |
07940232121
drapurvaparekh333@gmail.com |
| Dr Jacob George |
Medical College |
L -15, Jainagar Colony, Trivandrum- 695 011
Thiruvananthapuram
KERALA |
9447143992
drjacobgeo@rediffmail.com |
| Dr Sishir Gang |
Muljibhai Patel Urological Hospital |
Muljibhai Patel Urological Hospital/Kidney Hospital, Nadiad,
Dr. Virendra Desai Road, Nadiad- 387 001
Kheda
GUJARAT |
02682520323
sishirgang@hotmail.com |
| Dr Lloyd Vincent |
Narayana Hrudayalaya Hospitals |
Narayana Hrudayalaya Hospitals,
No.258/A, Bommasandra Industrial Area
Anekal Taluk , Bangalore-560 099
Bangalore
KARNATAKA |
9535012356
lloydvincent@hotmail.com |
| Dr Sanjeev Saxena |
Pushpawati Singhania Research Institute for Liver, Renal and Digestive Diseases |
Press Enclave Marg, Phase II, Sheikh Sarai, New Delhi- 110 017
New Delhi
DELHI |
01130611700
drsanjivsaxena@rediffmail.com |
| Dr Deodatta Chaffekar |
Rishikesh Medical Research Foundation and Shri Samarth Hospital |
9, Murkuthe colony, Gangapur road,
Nashik-422002
Nashik
MAHARASHTRA |
91-9822038667
nchafy@hotmail.com |
| DrDinesh Khullar |
Sir Ganga Ram Hospital |
10, Room. No 4
Rajinder Nagar, Punjabi Bagh Extn,
New Delhi-110060
New Delhi
DELHI |
91-9819124066
khullar@del3.vsnl.net.in |
| Dr Gokulnath |
St. Johns Medical College Hospital |
St. Johns Medical College Hospital, Bangalore
34, Sarjapur Road, Bangalore-560 034
Bangalore
KARNATAKA |
08022065000
gokul_neph@yahoo.co.uk |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Astha Independent Ethics Committee |
Approved |
| Bangalore Central Ethics committee |
Approved |
| Ethics Committee Jaslok Hospital and Research Centre |
Submittted/Under Review |
| Ethics committee on clinical trials, Indraprastha Apollo Hospital |
Approved |
| Ethics Committee Sir Ganga Ram Hospital, Delhi |
Approved |
| Human Ethics committee |
Submittted/Under Review |
| Independent Ethics Committee |
Approved |
| Institutional Ethics Committee Amrita Institute of Medical Sciences (AIMS), Kerala |
Approved |
| Institutional Ethics Committee Kerala Institute of Medical Sciences (KIMS), Kerala |
Approved |
| Institutional Ethics Committee Shatabadi Hospital, Nasik |
Approved |
| Institutional Review Board of Pushpawati Singhania Research Institute for Liver, Renal and Digestive Diseases |
Approved |
| Muljibhai Patel Society for research in Nephro-urology |
Approved |
| Narayana Hrudayalaya Medical Ethics Committee |
Approved |
| St. Johns Medical College and Hospital Institutional Ethical Review Board |
Approved |
| The Internal Review Borad, Institute of Kidney Diseases and Research Centre (IKRDC)-Institute of Transplantation Sciences (ITS), Ahmedabad |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Anaemia in Patients with Chronic Renal Failure, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Novel Erythropoiesis Stimulating Protein (NESP) |
Dose:10 to 40 micrograms per mL
Duration: 32 weeks
Route of administration: Intravenous |
| Comparator Agent |
Recombinant Human Erythropoietin (r-HuEPO) |
Dose:33.6 micrograms/0.4 mL, 25.2 micrograms/0.3 mL and 67.2 micrograms/mL
Duration: 32 weeks
Route of administration: Intravenous |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for first registration:
Following patients will be included in the study at first registration:
1. Male or female patients diagnosed with CRF, aged 18 to 80 years, inclusive.
2. Patient/LAR (legally acceptable representative)of patient willing to sign and date written informed consent to participate in the study. However, if the patient/LAR of patient is illiterate, the impartial witness would sign the ICF.
3.Patients receiving HD two to three times per week for at least 12 weeks before first registration
4.Patients with no planned change in dialysis modality and with no planned renal transplant.
5.Patients managing renal anaemia by receiving an administration of r-HuEPO intravenous or sub-cutaneous (at least once per week) for at least 8 weeks before the first registration
Inclusion criteria for second registration:
1.Patients receiving HD (includes hemodialysis filtration) two to three times per week for 8 weeks after the first registration
2. Patients who received sub cutaneous r HuEPO before first registration and then are continued and stabilized on IV administration of r HuEPO during the 8 weeks of Screening and Baseline period before second registration.
3. Patients receiving an administration of IV r-HuEPO product twice or three times weekly (dose levels 2, 3 and 4) for 8 weeks after the first registration.
4.Patients with at least 9.0 g/dL and
less than or equal to 12.0 g/dL of the average Hb concentration during the baseline period (Week -4, Week -3, Week -2 and Week 1)
5.Patients with at least 9.0 g/dL and less than or equal to 12.0 g/dL of the average Hb concentration during the screening period (Week -7, -6 and -5)
6.Patients with at least 20% of TSAT and more than or equal to 100 ng/mL of ferritin at the test during the baseline period (Week -4 or -2)
|
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| ExclusionCriteria |
| Details |
Exclusion criteria for second registration:
1.Patients with uncontrolled hypertension (patients with over 100 mm Hg of diastolic blood pressure before HD at over 1/3rd of the BP measurements for 12 weeks before the second registration
2.Patients with congestive heart failure (CHF) of grade III or higher (as per New York Heart Association Class III)
3.Patients with malignancy (including hematologic malignancy), systemic blood disorder (myelodysplastic syndrome, pure red cell aplasia, hemolytic anaemia, or the like)
4.Patients who have known human immunodeficiency virus (HIV) infection
5. Patients who have received an administration of anabolic hormone or testosterone enanthate within 12 weeks before the second registration.
6.Patients who had received administration of another study drug within 12 weeks before the second registration
7.Patients who have previously received an administration of darbepoetin
8.Patients who are confirmed to have a serious allergy or serious drug allergy
9.Patients who are hypersensitive to r-HuEPO
10.Female patients who are pregnant, breast feeding, or suspected to be pregnant
11.Patients whose aspartate transaminase (AST)/ serum glutamate oxaloacetate transaminase (SGOT) or alanine transaminase (ALT)/ serum glutamate pyruvate transaminase (SGPT) is 2 times the institutional upper normal limit at the test during the baseline period (Week 4)
12.Patients who have undergone major surgery associated with major bleeding within 16 weeks before the second registration (excluding vascular access surgery)
13.Patients who have received a blood transfusion within 16 weeks before the second registration
14.Patients with immunosuppressive therapy
15.Patients who are judged by the investigators to be ineligible for participation in this study |
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Method of Generating Random Sequence
Modification(s)
|
Random Number Table |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Changes in Hemoglobin (Hb) level in between the baseline period and the evaluation period |
Day -49 to Day 168 |
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Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
| Unstable Hemoglobin (Hb) level during the evaluation period |
Day 0 to Day 168 |
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Target Sample Size
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Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/06/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Study Design: This study is a randomized, open-label, two-arm, multicentric, phase-III trial comparing two drugs; novel erytropoiesis stimulating protein (NESP) and Recombinant Human Erythropoietin (r-HuEPO).
Study Duration: The study duration is 32 weeks for each patient and includes 126 patients with anaemia in chronic renal failure; the study will be conducted at five centers in India.
Primary Outcome: The primary outcome will be changes in Hemoglobin (Hb) level between the baseline period and the evaluation period.
Secondary Outcome: The secondary outcome will be evaluation unstable Hb levels during the evaluation period. |