| CTRI Number |
CTRI/2013/09/003956 [Registered on: 05/09/2013] Trial Registered Prospectively |
| Last Modified On: |
19/06/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Peg EPO in the Treatment of Anemia due to Chronic Kidney Disease |
|
Scientific Title of Study
|
A Prospective, Comparative, Randomized, Multicenter Study of Peg EPO in the
Treatment of Anemia due to Chronic Kidney Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IBPL_EP_01 Version 1.0 ; 26th December, 2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naman Shah |
| Designation |
Manager Medical Services |
| Affiliation |
Intas Biopharmaceuticals Limited |
| Address |
423/P/A, Sarkhej-Bavla Highway, Moraiya, Tal: Sanand
Ahmadabad
GUJARAT
382210
India |
| Phone |
91-79-40202358 |
| Fax |
91-79-40202022 |
| Email |
naman_shah@intaspharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naman Shah |
| Designation |
Manager Medical Services |
| Affiliation |
Intas Biopharmaceuticals Limited |
| Address |
423/P/A, Sarkhej-Bavla Highway, Moraiya, Tal: Sanand
Ahmadabad
GUJARAT
382210
India |
| Phone |
91-79-40202358 |
| Fax |
91-79-40202022 |
| Email |
naman_shah@intaspharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naman Shah |
| Designation |
Manager Medical Services |
| Affiliation |
Intas Biopharmaceuticals Limited |
| Address |
423/P/A, Sarkhej-Bavla Highway, Moraiya, Tal: Sanand
Ahmadabad
GUJARAT
382210
India |
| Phone |
91-79-40202358 |
| Fax |
91-79-40202022 |
| Email |
naman_shah@intaspharma.com |
|
|
Source of Monetary or Material Support
|
| Intas Biopharmaceuticals Ltd. |
|
|
Primary Sponsor
|
| Name |
Intas Biopharmaceuticals Ltd |
| Address |
Plot No: 423 P/A, Sarkhej Bavla Highway,
Moraiya; Tal: Sanand, Ahmedabad Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
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 |
| Dr Lalit Agarwal |
Apollo Glaneagles Hospitals |
Internal Medicine & Rhematology, 58, canal circular road-700054,India
Kolkata
WEST BENGAL |
9830054955
drlalitagarwal@gmail.com |
| Dr Manju Agarwal |
Artimis Health Institute |
Sector – 51 – 122 001, India
Gurgaon
HARYANA |
9810065613
agg.manju@gmail.com |
| Dr B Sudhakar |
Axon Hospital |
8-3-215 Srinivas Nagar Colony (West), Opp ICICI Bank, S. R. Nagar-500038
Hyderabad
ANDHRA PRADESH |
9246542123
drbsudhakar@yahoo.com |
| Dr Javed Vakil |
Care Institute of Medical Sciences |
Nr. Shukan Mall, Off Science City Road, Sola–380060
Ahmadabad
GUJARAT |
9824919119
kdtf08@gmail.com |
| Dr Vatsa Patel |
Divyam Hospital |
41-43, Maher Park – A, Near Athwa Gate,Ring Road,395001,India
Surat
GUJARAT |
9825289954
dr_vatsa@yahoo.com |
| Dr H L Trivedi |
Institute of Kidney Disease & Research Centre, B J Medical college and Civil Hospital campus |
B. J. Medical college & Civil Hospital Campus, Asarwa 380016, India.
Ahmadabad
GUJARAT |
917922685600
drpankajrshah@yahoo.com |
| Dr Arpita Ray Choudhary |
IPGMER |
IPGMER & SSKM Hospital, Department of Nephrology, 244, AJC Bose Road,-700020, India
Kolkata
WEST BENGAL |
9433254601
lahiri.arpi@gmail.com |
| Dr Krishnaswamy Sampathkumar |
Meenakshi Mission Hospital & Research Centre |
Lake area, Melur road, Madurai – 625 107,India
Madurai
TAMIL NADU |
9994872250
drksampath@gmail.com |
| Dr Ishtiaque Ahmed |
Narayana hrudayala hospital |
258/A Bommasandra Industrial area Anekal,Taluk-560099
Bangalore
KARNATAKA |
9980100841
ishthi@yahoo.co.in |
| Dr Deo Nidhi Mishra |
Nirmal Hospital |
Opp. Medical College Gate No. 3, Kanpur Road, Jhansi-284128
Jhansi
UTTAR PRADESH |
9415031689
drmishra.nirmal@gmail.com |
| Dr Ravi Bansal |
Pushpawati Singhania Research Institute |
Sheikh Sarai-II-110017
New Delhi
DELHI |
9313257445
dr_ravibansal@yahoo.com |
| Dr Sanjay Srinivasa |
Sapthagiri Institute Of Medical Sciences and Research Center |
#15, Chikkasandra, Hesaraghatta Main Road-560090
Bangalore
KARNATAKA |
9901996755
drsanjaysrinivas@yahoo.co.in |
| Dr Divyesh Viroja |
Shree Giriraj Multispeciality Hospital |
"150 ft Ring Road,
27 – Navjyot park Main Road,
Amin Marg Cross Road,–360 005,India
Rajkot
GUJARAT |
9825256578
divyeshviroja@gmail.com |
| Dr A K Bhalla |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital,Sir Ganga Ram Hospital Marg, Rajinder Nagar,New Delhi – 110 060, India
New Delhi
DELHI |
09811047377
bhallaak@yahoo.com |
| Dr Dhananjay Agarwal |
SMS Hospital |
JLN Marg - 302004, India
Jaipur
RAJASTHAN |
9414479790
dhananjaynephro@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Axon Institutional Ethics Committee,Dr. B Sudhakar |
Approved |
| EC of Care Institute of Medical Sciences,Dr. Javed Vakil |
Submittted/Under Review |
| Ethics Committee of Divyam Hospital,Dr. Vatsa Patel |
Approved |
| Ethics Committee of SMS Medical College & Hospital,Dr. Dhananjay Agarwal |
Approved |
| Ethics Committee,Sir Ganga Ram Hospital,Dr. Bhalla |
Approved |
| Institutional Ethics Committee Artimis Health Institute,Dr. Manju Agarwal |
Approved |
| Institutional Ethics Committee, Apollo Glaneagles Hospitals,Dr. Lalit Agarwal |
Approved |
| Institutional Ethics Committee, Meenakshi Mission Hospital & Research Centre,Dr. Krishnaswamy Sampathkumar |
Approved |
| Institutional Ethics Committee, Shree Giriraj Multispeciality Hospital,Dr. Divyesh Viroja |
Approved |
| Institutional Ethics Committee,Institute of Post Graduate Medical Education & Research_Dr. Arpita Ray_Kolkata |
Approved |
| Narayana Hrudayalaya Medical Ethics Committee,Dr. Ishtiaque Ahmed |
Approved |
| Nirmal Hospital Institutional Ethics Committee,Dr. Deo Nidhi Mishra |
Approved |
| Pushpawati Singhania Research Institute Ethics Committee,Dr. Ravi Bansal |
Approved |
| Sapthagiri Institute Of Medical Sciences and Research Center Institutional Ethics Committee,Dr. Sanjay Srinivasa |
Approved |
| The internal review Board, Institue of Kidney Disease & Research Centre _ Dr. H L Trivedi Ahmedabad. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Anemia due to Chronic Kidney Disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MIRCERA® |
0.6 microgram/kg body weight, once every 2 weekly as subcutaneous Injection up to10 weeks |
| Intervention |
Peg EPO |
0.6 microgram/kg body weight, once every 2 weekly as subcutaneous Injection up to10 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex with an age ≥ 18 years
2.Anemia
3.Have not participated in any other investigational drug trial in the last 3 months
4.Have given informed consent to participate in this study |
|
| ExclusionCriteria |
| Details |
1.Patient who have overt gastrointestinal bleeding,or bleeding episode necessitating transfusion within 4 weeks before screening.
2.Patient who have any active malignant disease (except non-melanoma skin cancer).
3.Patients with known hypersensitivity to mammalian cell-derived products or Albumin (Human)
4.Patients with uncontrolled hypertension.
5.Patients scheduled for major elective orthopaedic surgery or renal transplant and not participating in an autologous blood predonation
programme, patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident or any serious life threatening disease or disorder.
6.Any history or presence of clinically significant disease or any other condition which, in the opinion of the Investigator could jeopardize the safety of the subject or the validity of the study results
7.Patient with any specific disease who are not eligible for the use of erythropoiesis stimulating agent (ESA).
8.Hypersensitivity to the active substance or to any of the excipients
9.Patients who for any reason cannot receive adequate antithrombotic prophylaxis
10.Pregnant and / or Breast feeding Female Patient |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare proportion of patients achieving a pre-specified Hb target |
End of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare mean dose of Intas Peg EPO with MIRCERA® required to achieve target Hb |
84 Days |
| To observe & compare Incidence of drug related Adverse Events as assessed by clinical examination, vitals and / or laboratory parameters |
84 Days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2013 |
| 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="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In chronic kidney disease, as nephrons are progressively lost, the body attempts to maintain homeostasis via multiple adaptive and maladaptive processes, including a complex range of biochemical and physiologic abnormalities.
As anemia is very common in CKD patients, treatment with erythropoiesis stimulating agent (ESAs) is recommended for patients with chronic kidney disease, even those with moderate disease not yet requiring dialysis, need to be periodically monitored for anemia. Pegylated Recombinant Erythropoietin is a pegylated form of Erythropoietin which can be used IV or subcutaneously for treatment of anemia due to chronic kidney disease at once a twice weekly dose. |