FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2013/09/004005 [Registered on: 20/09/2013] Trial Registered Prospectively
Last Modified On: 21/06/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Other (Specify) [recombinant product]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, R-TPR-026 and Aranesp® in patients for correction of anemia due to Chronic Kidney Disease 
Scientific Title of Study   Prospective, multi-centre, randomized, open-label, twoarm, parallel group, active control, comparative clinical study to evaluate efficacy and safety of R-TPR-026/ Aranesp® when given subcutaneously in patients for correction of anemia due to Chronic Kidney Disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RLS/TP/2012/03, version 2.0, dated 29.04.2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Prashant Pandya 
Designation  General Manager - Clinical development 
Affiliation  Reliance Life Sciences Pvt.Ltd 
Address  Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai

Thane
MAHARASHTRA
400701
India 
Phone  02240678236  
Fax  02240678299  
Email  prashant.pandya@relbio.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Sanjeev Hegde 
Designation  Medical Monitor 
Affiliation  Reliance Life Sciences Pvt.Ltd 
Address  Reliance Life Sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre R-282 TTC area of MIDC Rabale Navi Mumbai

Thane
MAHARASHTRA
400701
India 
Phone  02240678208  
Fax  02240678299  
Email  sanjeev.hegde@relbio.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Prashant Pandya 
Designation  General Manager Clinical Research Services 
Affiliation  Reliance Life Sciences Pvt.Ltd 
Address  Reliance Life Sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai

Thane
MAHARASHTRA
400701
India 
Phone  02240678236  
Fax  02240678299  
Email  prashant.pandya@relbio.com  
 
Source of Monetary or Material Support  
Reliance Life sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701. India 
 
Primary Sponsor  
Name  Reliance Life sciences Pvt Ltd 
Address  Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC, Thane Belapur Road Rabale, Navi Mumbai 400 701. India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 21  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aditya Bhabhe  Bharati Vidyapeeth Deemed University Medical College  Bharati Vidyapeeth Deemed University Medical College, Department of Medicine, Pune-Satara Road, Pune - 411043
Pune
MAHARASHTRA 		 020-24335701

dr.bhabhe@gmail.com 
Dr Charulata Bawankule  Government Medical College, Nagpur  GOvernment medical college, Tukdoji Square, Nagpur
Nagpur
MAHARASHTRA 		 919823130707

pk52kule@yahoo.com 
Dr Valentine Lobo  KEM Hospital  KEM Hospital, 489, Rasta Peth, Sardar Moodliar Peth, Pune - 411 011
Pune
MAHARASHTRA 		 9823190535

nephron@kemhospital.org 
Dr K C Gurudev  M S Ramaiah Medical College and Hospitals  M S Ramaiah Medical College and Hospitals, Department of Nephrology, New BEL Road, MSRIT Post, Bangalore - 560054
Bangalore
KARNATAKA 		 080-22183063

gurudevkc@gmail.com 
Dr Rekha MC  Mandya Institute of Medical Sciences  Mandya Institute of Medical Sciences, Mandya
Mandya
KARNATAKA 		 9845343736

rekhamc73@gmail.com 
Dr Vishwanath Siddini  Manipal Hospitals  Manipal Hosptals, Department of Nephrology, 98, HAL Airport Road, Bangalore
Bangalore
KARNATAKA 		 080-25023265

vishwanath.siddini@manipalhospitals.com 
Dr Ravinder Ahlawat  Maulana Azad Medical College  Maulana Azad Medical College, Lok Naya Hospital, Bahadur Shah Zafar Marg, New Delhi - 110002
New Delhi
DELHI 		 9782300231

ahlawat.ravi@gmail.com 
Dr Mahendra Parmar  Medical College & SSG Hospital, Jail Road Vadodara  Additional professor, Dept of Medicine, medical college & SSG Hospital, Jail Road, Vadodara
Vadodara
GUJARAT 		 9824326550

mcparmar1961@gmail.com 
Dr Rokade Mahesh Shivaji  Medipoint Hospitals Pvt. Ltd.  Medipoint Hospitals Pvt. Ltd. New D.P.Road, Aundh Pune
Pune
MAHARASHTRA 		 9657575900

drmaheshsr@yahoo.co.in 
Dr Kalpesh Gohel  Muljibhai Patel Urological Hospital  Muljibhai Patel Urological Hospital, Dr. Virendra Desai Road, Nadiad
Kheda
GUJARAT 		 9824447362

gohelk2000@gmail.com 
Dr Srinivasa M  Mysore Medical College & Research Institute  Mysore Medical College & Research Institute, K.R. Hospital, Irwin Road, Mysore
Mysore
KARNATAKA 		 9845035639

drsrinivasam@gmail.com 
Dr Bhushan Raju  Nizams Institute of Medical Sciences  Nizams Institute of Medical Sciences, Panjagutta Hyderabad
Hyderabad
ANDHRA PRADESH 		 9848492951

sreebhushan@hotmail.com 
Dr Manisha Sahay  Osmania General Hospital  Osmania General Hospital, Afzalgunj, Hyderabad
Hyderabad
ANDHRA PRADESH 		 9849097507

manishasahay@gmail.com 
Dr Jitendra Falodia  S. P. Medical College, Bikaner  Department of Nephrology, S. P. Medical College & AG of Hospitals, Bikaner - 334003
Bikaner
RAJASTHAN 		 0151-2226360

falodia.jitendra@gmail.com 
Dr Atul Sajgure  Sahayadri Clinical Research & Development Centre, A unit of Sahayadri Hospitals Ltd.  Sahayadri Clinical Research & Development Centre, A unit of Sahayadri Hospitals Ltd, 33/34 B Makarand Bhave Path, Karve Road, Pune
Pune
MAHARASHTRA 		 9890676278

atulsajgure@yahoo.com 
Dr Hase Niwrutti Khandu  Seth GS Medical College and KEM Hospital  Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai - 400 012
Mumbai
MAHARASHTRA 		 022-24136051

nk_hase@hotmail.com 
Dr Prakash Khetan  Shravan Hospital and Kidney Institute  Shravan Hospital and Kidney Institute, 239, Nandanvan Cement Road, Nagpur
Nagpur
MAHARASHTRA 		 9823071748

prakashkhe@gmail.com 
Dr A K Bhalla  Sir Ghangaram Hospital  Sir Ghangaram Hospital, Sir Gangaram marg, Old Rajinder Nagar, New Delhi
New Delhi
DELHI 		 9811047377

bhallaak@yahoo.com 
Dr B Sudhakar  St. Theresas Hospital  St. Theresas Hospital, Sanathnagar, Hyderabad
Hyderabad
ANDHRA PRADESH 		 9246542123

drbsudhakar@yahoo.com 
Dr Sonal Dalal  Sterling Hospital  Sterling Hospital, Sterling Hospital Road, Memnagar, Ahmedabad - 380052, Gujarat
Ahmadabad
GUJARAT 		 079-26652220

sonalsanjiv@yahoo.com 
Dr Kalpana S Mehta  T. N. Medical College and B Y L Nair Charitable Hospital  T. N. Medical College and B Y L Nair Charitable Hospital, Department of Nephrology, OPD Building, 7th Floor, A Nair Road, Mumbai Central, Mumbai - 400 008
Mumbai
MAHARASHTRA 		 020-23027680

kalpana.drs@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Bharati Vidyapeeth Deemed University, Institutional Ethics Committee   Approved 
Ethics Committee - S. P. Medical College and A. G. of Hospitals  Approved 
Ethics committee M S Ramaiah Medical College and Hospitals  Approved 
Ethics Committee of Manipal Hospitals  Approved 
Ethics committee Sir Ghangaram Hospital, New Delhi  Approved 
Institutional Ethics Committee for Human Research (IECHR) Medical college & SSG Hospital Baroda  Approved 
Institutional Ethics Committee, Govt. Medical College, Nagpur  Approved 
Institutional Ethics Commmittee - Seth GS Medical Colege and KEM Hospital,  Approved 
Institutional Ethics Commmittee - Sterling Hospital  Approved 
Institutional Ethics Commmittee Maulana Azad Medical College  Approved 
Institutional Ethics Commmittee of Topiwala National Medical College and BYL Nair Charitable Hospital  Approved 
KEM Hospital Research Centre Ethics Committee  Approved 
Nizams Institute of Medical Sciences, Hydrabad  Approved 
Sahayadri Hospital Ltd, Ethics Committee, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients for correction of anemia due to Chronic Kidney Disease ,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Aranesp®  Dose:0.75 mcg/kg, Frequency: Once every 2 weeks during 24 weeks, Mode of administration: Subcutaneous  
Intervention  R-TPR-026  Dose:0.75 mcg/kg, Frequency: Once every 2 weeks during 24 weeks, Mode of administration: Subcutaneous  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Diagnosed with anemia due to Chronic Kidney Disease (CKD)
2 On hemodialysis or peritoneal dialysis prior to enrollment in the study
3 ESA therapy naive or ESA therapy-free for at least 3 months
4 Hb < 9 g/dL based on two screening visits at least 7 days apart
5 TSAT ≥ 20%
6 Females of childbearing potential should be willing to use an approved method of double-barrier contraception and should have a negative pregnancy test.
7 Able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
 
 
ExclusionCriteria 
Details  1. Current severe, uncontrolled systemic disease (e.g., clinically significant hematological disease such as sickle cell anemia, myelodysplasia, hematological malignancy, hemolytic anemia, inflammatory, infectious, psychiatric or other conditions interfering with erythropoietic response)
2. RBC transfusion to treat anemia within 8 weeks before enrollment or scheduled to receive RBC transfusion
3. New York Heart Association class III or IV Congestive Heart Failure
4. Uncontrolled hypertension (Diastolic BP 110 mmHg or systolic BP 180 mmHg) during screening
5. Major surgical procedure in last 12 weeks before enrollment or anticipation of the need for major surgery during the course of study treatment
6. Androgen therapy within 12 weeks prior to start of study
7. Scheduled to receive a renal transplant
8. Cardiovascular disease (Acute myocardial infarction or hospitalization for CHF within 12 weeks before enrollment)
9. Evidence of conditions like deep vein thrombosis, cerebrovascular event (stroke or transient ischemic attack) within 12 weeks before enrollment
10. Uncontrolled hyper parathyroidism 1500 pg/ml during last 12 months
11. Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
12. History of intolerance or hypersensitivity to darbepoetin alfa
13. Pregnant or breast-feeding women
14. Women of child bearing potential who are not using effective contraception during participation in the study and do not agree to do so for at least 28 days after final
dose of investigational product.
15. Subjects with HIV, HBsAg, HCV test positive.
16. Participation in any study within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course
of this study
17. Any other condition which investigator feels would pose a significant hazard to subject if IP is administered.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary efficacy will be assessed by Hemoglobin responder rate i.e., proportion of patients achieving 1 g/dL rise in Hb from baseline at Week 8  week 8 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients achieving rise in hemoglobin i.e., 1 g/dL rise from baseline, at Week 24  week 24  
Average dose of R-TPR-026/Aranesp® administered for achievement of rise of hemoglobin in the target range (9-12 g/dL) at Week 24  week 24  
Proportion of patients maintaining mean Hb within target range (9-12 g/dL) at Week 24  week 24  
Mean change in Hb level between the screening/baseline period and end of the study  week 24  
Pharmacokinetic parameters (Cmax and AUC0-168) will be calculated for single dose of R-TPR-026 and Aranesp®  week 24  
Pharmacodynamic parameter
o Reticulocyte count assessed at Day 2 and Day 4 of Week 0, every week from Week 1 to Week 8, every alternate week from Week 10 to Week 20 and every week from Week 21 to Week 24
 		 week 24  
Evaluation of safety  week 24  
 
Target Sample Size
Modification(s)  		 Total Sample Size="104"
Sample Size from India="104" 
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)
Modification(s)  		 22/04/2014 
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
Modification(s)  		 Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a prospective, multi-centre, open-label, two-arm, parallel group, active-control, randomized comparative clinical study. The present study will evaluate the efficacy

safety to evaluate efficacy and safety of R-TPR-026 and  Aranesp® when given subcutaneously in patients for correction of anemia due to Chronic Kidney Disease.

The primary outcome measures will be assessed by Hemoglobin responder rate i.e., proportion of patients achieving >1 g/dL rise in Hb from baseline at Week 8. 105 subject will be recruited from 08 sites in India.   
Close