| CTRI Number |
CTRI/2012/12/003201 [Registered on: 10/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
28/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to determine the Safety & Efficacy of Recombinant Human Erythropoietin (rHuEPO) Injection In Treatment of Anemia Associated With Chronic Renal Failure |
|
Scientific Title of Study
|
A Multicentric, Open-label, Randomized, Comparative, Non-inferiority, Phase III Clinical Trial to Determine The Safety & Efficacy of Recombinant Human Erythropoietin (rHuEPO) Injection Manufactured By Beijing Four Rings Biopharmaceuticals Co. Ltd., China In Treatment of Anemia Associated With Chronic Renal Failure. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Trigenesis/CT/Eryth/012011, Version No. 00, Dated 29/01/11 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Milan Satia |
| Designation |
Chief Executive Officer |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
5/C, Vardan Tower, Nr. Vimal House, Vithakbhai Patel Colony, Navrangpura
Ahmadabad
GUJARAT
380014
India |
| Phone |
09825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milan Satia |
| Designation |
Chief Executive Officer |
| Affiliation |
Ethicare Clinical Trial Services |
| Address |
5/C, Vardan Tower, Nr. Vimal House, Vithakbhai Patel Colony, Navrangpura
Ahmadabad
GUJARAT
380014
India |
| Phone |
09825585119 |
| Fax |
|
| Email |
milansatia@ethicare-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Kapil Kumar Jain |
| Designation |
Chief Executive Officer |
| Affiliation |
Trigenesis Life Sciences Pvt. Ltd. |
| Address |
KCI Chambers, No. 160, 2nd Floor, 5th Main Road, Chamarajpet
Bangalore
KARNATAKA
560018
India |
| Phone |
08042154535 |
| Fax |
|
| Email |
kapil@trigenesislife.co.in |
|
|
Source of Monetary or Material Support
|
| Trigenesis Life Sciences Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Trigenesis Life Sciences Pvt Ltd |
| Address |
KCI Chambers, No. 160, 2nd Floor, 5th Main Road, Chamarajpet,Bangalore -560 018, INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jagdeep Shah |
Dr Jivraj Mehta Smarak Health Foundation |
Ground floor, Ratubhai Adani Arogyadham, Dr Jivraj Mehta Marg
Ahmadabad
GUJARAT |
07926639840
research@jivrajhealthcare.org |
| Dr Vatsa Patel |
Pravar Superspeciality Centre |
First Floor, Room No. 01, B/s. Ramji Mandir, Opp. Navdi Ovara,
Nanpura
Surat
GUJARAT |
02612460202
dr_vatsa@yahoo.com |
| Dr Sanjay Srinivasa |
Sapthagiri Institute of Medical Sciences & Research Centre |
Ground Floor, Nephrology Department, 15, Chikkasandra, Hesaragatta Main Road
Bangalore
KARNATAKA |
08028393392
sapthagiriclintrac@gmail.com |
| Dr Jyoti Mannari |
Shree Krishna Hospital and Medical Research Centre |
Ground Floor, Room No. 108, Department of Medicine, Gokalnagar, Karamsad
Anand
GUJARAT |
02692222130
jyotigm@charutarhealth.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Dr Jivraj Mehta Smarak Health Foundation Ethics Committee for Dr Jagdeep Shah |
Approved |
| Human Research Ethics Committee |
Approved |
| Sapthagiri Institute of Medical Sciences & Research Centre Institutional Ethics Committee |
Approved |
| Spandan Independent Ethics Committee / Ahmedabad - Gujarat / Dr Vatsa |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Anemia associated with Chronic Renal Failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eprex (r-Hu-EPO) |
50 IU/Kg, two times in a week for 12 weeks by intravenous route |
| Intervention |
Recombinant Human Erythropoietin (rHuEPO) Injection |
50 IU/Kg, two times in week for 12 weeks by intravenous route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients diagnosed with chronic renal failure, age 18 – 80 years (both inclusive).
2. Patient / legally acceptable representative (LAR) 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. Patient receiving Haemodialysis two-three times per week for at least 6 weeks with or without Recombinant Human Erythropoietin (rHuEPO) treatment before screening.
4. Patients with no planned change in dialysis modality and no planned with renal transplant.
5. Patients with at least 9.0 g/dL and less than or equal to 12.0 g/dL of the haemoglobin concentration during the screening period.
6. Willingness to comply with the study schedule and procedures.
|
|
| ExclusionCriteria |
| Details |
1. Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
2. Patients with history of uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or Systolic blood pressure; more than or equal to 180 mm Hg) despite at least one anti-hypertensive therapy during past three weeks.
3. Patients with congestive heart failure (CHF).
4. Patients with history of malignancy (including hematologic malignancy) and systemic blood disorder (myelodysplastic syndrome, pure red cell aplasia, hemolytic anaemia).
5. Patients with history of blood transfusion in past six weeks.
6. Patients with history of major surgery in last 12 weeks or planned surgery in next 12 weeks.
7. Patients with immunosuppressive therapy.
8. Patients with history of significant underlying disease or known hypersensitivity to rHuEPO.
9. Patient whose SGPT or SGOT level is two times the upper limit of normal laboratory range during screening.
10. Patient with history of hypersensitivity to albumin (human), hypersensitivity to mammalian cell derived products.
11. Patients with history of smoking (10 cigarettes/day) and/or consumption of alcohol (2 small pegs/day) within last three months.
12. Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
13. Participation in any other clinical trial during last 30 days. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in haemoglobin level from baseline |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in hematocrit level from baseline, Unstable haemoglobin level during treatment period |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
23/10/2012 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a multicentric, open-label, randomised, comparative, non-inferiority phase III clinical trial involving patients with anemia associated with chronic renal failure receiving Recombinant human erythropoietin injection (Investigationa product) or Eprex (comparator product) two times in a week for 12 weeks. |