FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2012/07/002835 [Registered on: 27/07/2012] Trial Registered Prospectively
Last Modified On: 20/01/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of Darbepoetin alfa in the treatment of anemia caused by chronic kidney disease. 
Scientific Title of Study   A randomized, open label, multi-center study to evaluate the efficacy, tolerability and safety of Darbepoetin alfa as compared to Erythropoietin in anemia associated with chronic kidney disease (CKD) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/Darb/05/2011 Version 1.1 dated 24/Dec/2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Shubhadeep Sinha MD 
Designation  Associate Vice President and Head 
Affiliation  Hetero Group 
Address  Clinical Development and Medical Affairs, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar,Hyderabad

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  sd.sinha@heterodrugs.com  
 
Details of Contact Person
Public Query  
Name  Dr Rudolph Julius D Almeida  
Designation  Project Manager 
Affiliation  Hetero Drugs Limited 
Address  Clinical Development and Medical Affairs, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar,Hyderabad

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  rudolph.a@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Drugs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Andhra Pradesh, India-500018 
 
Primary Sponsor  
Name  Hetero Drugs Limited 
Address  Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Andhra Pradesh, India-500018 
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 = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atul Sajgure   A.M.A.I.Charitable Trust’s ACE Hospital  SNo.32/2A,Erandawane,Gulavani Maharaj Path, Pune-411004
Pune
MAHARASHTRA 		 09890676278

atulsajgure@yahoo.com 
Dr Amitabh Anantrao Kulkarni MD DNB  Apollo Hospitals  Consultant Nephrologist, Near Apollo health street, Jubilee Hills, Hyderabad, Andhra Pradesh- 500 096
Hyderabad
ANDHRA PRADESH 		 04023231380

amitabhkulkarni@gmail.com 
Dr Dilip M Babu MD DM  Apollo Hospitals  Consultant Nephrologist, 3-5-874/1, Hyderguda, Hyderabad, Andhra Pradesh-500 029
Hyderabad
ANDHRA PRADESH 		 04023231380

drdilipmbabu@gmail.com 
Dr Santosh Kumar Durugkar MD DNB  Ashwini Hospital and Ramakanth Heart Care Center  Consultant Nephrologist, Shivaji Nagar, Nanded, Maharashtra- 431 602
Nanded
MAHARASHTRA 		 02462-235611

sdd91@yahoo.co.in 
DrKalpana Shailesh Mehta MD DNB  B.L.Y Nair Hospital  Department of Nephrology, A.L Nair Road,Mumbai Central, Mumbai, Maharashtra-400 008
Mumbai
MAHARASHTRA 		 022-23027680

kalpana.drs@gmail.com 
Dr Vikranth Reddy Pinnama Reddy MD DNB  Care Hospitals  Consultant Nephrologist, Road No. 1, Banjara Hills, Hyderabad, Andhra Pradesh – 500 034
Hyderabad
ANDHRA PRADESH 		 04023234444

vikranthreddy@yahoo.com 
Dr S Subhramanyam MD MISN  Devi Shetty Hospital  Senior Consultant Nephrologist, Near Trimulgherry Bus Station, Siddipet Road, Kushalchand Colony, Trimulgherry, Secunderabad, Andhra Pradesh -500 015
Hyderabad
ANDHRA PRADESH 		 04065269990

sreepada11@gmail.com 
Dr Rajendra Pandey MD DM  Institute of Post Graduate Medical Education And Research  Department of Nephrology, 244, A.J.C Bose Road, Kolkata, West Bengal - 700 020
Kolkata
WEST BENGAL 		 03322235181

rajensankrityan@gmail.com 
Dr Dilip Kumar Pahari MD DM   Medica Hospitals Pvt. Ltd  Department of Nephrology, Medica institute of kidney diseases, 127, Mukundapur, E.M.Bypass, Kolkata, West Bengal – 700 099
Kolkata
WEST BENGAL 		 03324169200

dilip.pahari@medicasynergie.in 
DrA Anuradha MD MNAMS  Mediciti Hospitals  Department of Nephrology, 5-9-22, Secretariat road, Hyderabad, Andhra Pradesh-500 063
Hyderabad
ANDHRA PRADESH 		 04023231111

ramananu@yahoo.com 
Dr Umapati Narasinha Hegde MD DNB  Muljibhai Patel Urological Hospital  Department of Nephrology, Dr. Virendra Desai Road, Nadiad, Gujarat -387 001
Kheda
GUJARAT 		 0268-2520323

umapatih@gmail.com 
DrApurva Parekh MD DM  Nidhi Health Care Ltd  Consultant Nephrologist, Shreekunj, Stadium Commerce Road, Navrangpura, Ahmedabad, Gujarat-380 009
Ahmadabad
GUJARAT 		 079-30179017

drapurvaparekh33@gmail.com 
Dr Javed MVakil  Shubham Super speciality Hospital  KDTF, 4th Floor, Opp.Bank of Baroda, Near Sardar Patel statue, Sardar Patel Colony, Naranpura, Ahmedabad-380013, Gujarat,
Ahmadabad
GUJARAT 		 09824919119

drjmvakil@gmail.com 
Dr Dinesh Khullar  Sir Ganga Ram Hospital   Rajinder Nagar, New Delhi-60 India
New Delhi
DELHI 		 01142251636

drdineshkhullar@gmail.com 
Dr Kamal Goplani  Swapn Health Care Hospital  Ground floor, Sardar complex, Opp. Govindvadi,Isanpur, Ahmedabad-382443
Ahmadabad
GUJARAT 		 07925391810

Kamalgoplani@gmail.com 
DrGeorgi Abraham MD FRCP  Tanker Foundation  Senior Consultant Nephrologist, 17, Wheatcrofts Road, Nungambakkam, Chennai, Tamil Nadu - 600 034
Chennai
TAMIL NADU 		 04443090998

abraham_georgi@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
ACE hospital and research centre ethics committee  Approved 
Adarsh Ethics committee  Approved 
Apollo Hospital Institutional Ethics Committee_Dr Amitabh  Approved 
Apollo Hospital Institutional Ethics Committee_Dr Dilip  Approved 
Ashwini Hospital and Ramakant Heart Care Centre_Dr Santosh  Approved 
Astha Independent Ethics Committee_Dr Apurva  Approved 
Care Foundation Institutional Ethical Committee_Dr Vikranth  Approved 
Institutional Ethics Committee of B.Y.L Nair Hospitals_Dr Kalpana  Approved 
IPGME&R Research Oversight Committee_Dr Rajendra  Approved 
Maarg Independent Ethics Committee_Dr Subramanyam  Approved 
Medica Superspecialty Hospital Clinical Research Ethics Committee_Dr Dilip  Approved 
Mediciti Ethics Committee_Dr Anuradha  Approved 
Muljibhai Patel Urological Hospital Ethics committee_Dr Umapati  Approved 
Sir Gangaram Hospital ethics committee  Approved 
Swapn ethics committee  Approved 
Tanker Foundation Institutional Ethics Committee_Dr Georgi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Anemia associated with Chronic Kidney Disease (CKD), (1) ICD-10 Condition: D631||Anemia in chronic kidney disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Darbepoetin alfa   0.45 mcg/kg, subcutaneous injection for not more than 36 weeks. 
Comparator Agent  Erythropoietin alfa   50 IU/kg, subcutaneous injection for not more than 36 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Patients/ Patient’s legally acceptable representative are willing to sign and date written informed consent to participate in the study. In c/o illiterate patients/patient’s LAR, the impartial witness would sign the ICF.
• Are of either sex aged 18 to 65 years (both inclusive)
• Predialysis stage of CKD (Stage 3 and 4 with GFR between 15-59 mL/min/1.73 m2
• Dialysis patients- Hemodialysis (with AV fistula) or peritoneal dialysis for last 4 weeks and have baseline Hb <12 gm/dL. using MDRD equation) and Mean baseline Hb 7-10 gm/dL (both inclusive). Patients below 7 gm/dl will not include in the study
• Clinically stable patients, who are erythropoietin-naïve or patients treated with erythropoietin but not within one week prior to screening.
• Have adequate Transferrin saturation (≥ 20%) and serum Ferritin (≥100 ng/mL-Predialysis and ≥ 200 ng/mL-Dialysis).
• Have expected survival of at least 6 months from time of enrollment (at the discretion of Principal Investigator).
 
 
ExclusionCriteria 
Details  • Patients on peritoneal dialysis with double lumen catheter within1 month of screening
• Hypertension not amenable to standard drugs over 2 weeks of screening period.
• Patients treated with Darbepoetin alfa in the past 3 months of screening.
• Uncontrolled diabetes mellitus with Hb A1C of 10 or greater.
• Congestive Heart Failure of any grade as per New York Heart Association classification.
• History of unstable angina or myocardial infarction in last 6 months.
• History of Grand mal seizures in last 2 years.
• Present with severe hyperparathyroidism (iPTH 1000 pg/mL for Dialysis and iPTH 400 pg/mL for Pre-dialysis).
• History of major surgery within 12 weeks of screening.
• Systemic hematological diseases including sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma and hemolytic anemia.
• Systemic infection, active inflammatory disease and malignancy.
• Active liver disease or hepatic enzymes elevated more than 2 times the upper limit of normal.
• Are treated with androgen therapy within 8 weeks of screening.
• Pregnant or suspected to be pregnant and breast-feeding women.
• Patients scheduled for renal transplant within last 3 months of screening.
• Patients who are hypersensitive to any of the active study drug substances and their excipients.
• Have occult blood in stool or any other known source of internal bleeding and confirmed gastrointestinal bleeding by endoscopy.
• Patients with seropositivity to Human Immunodeficiency Virus, Hepatitis B and/or Hepatitis C infection (in c/o liver enzymes-AST and ALT raised 2-times of laboratory normal values)
• Patients having active tuberculosis or any other active infection for previous one month.
• Patients malnourished patients with serum albumin 3.0 gm/dL (on HD and Predialysis) and 2.8 gm/dL (on PD).
• Patients undergoing blood transfusions within 2 weeks prior to screening.
• Patients who have history of immunosuppressive therapy within 1 month of screening.
• Patients having history of previous renal transplantation.
• Patients having participated in any other clinical trial within one month prior to screening.
• Predialysis- patients who have received dialysis or patients on dialysis and patients who are expected to receive dialysis in next 6 months (as per investigator’s discretion)
• Patients who are judged to be ineligible for participation in this study.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in Hemoglobin between baseline and First evaluation period with minimum 12 weeks of treatment for correction of anemia in both predialysis and dialysis patients.  First evaluation period-Last 4 weeks of correction phase 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in Hb & its variability in correction phase
Mean Darbepoetin alfa dose during evaluation periods
Evaluate the pharmacokinetics and immunogenicity
Proportion of patients achieving the Hb target defined as Hb increase of ≥1 gm/dL from baseline and Hb concentration of 10-12 gm/dL at the end of First evaluation period.
Time to initial achievement of Hb target as specified in the protocol.
Treatment emergent adverse events
 		 Baseline to Week 4
Correction phase not more than 24 weeks
Evaluation periods: Last 4 weeks of correction and maintenance phase
 
 
Target Sample Size   Total Sample Size="236"
Sample Size from India="236" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/08/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a phase III, randomized, open label, two arm, multi-center trial comparing the safety and efficacy of Darbepoetin alfa and Erythropoietin alfa in the treatment of anemia in chronic kidney disease in 236 predialysis and dialysis patients from India. Patients will be randomized in 1:1 ratio between treatment arms and based on previous erythropoietin status (treated or naïve) dose for Darbepoetin alfa and Erythropoietin alfa are administered by subcutaneous injection. The primary outcome will be to assess mean change in hemoglobin between baseline and first evaluation period between the two treatment arms. The secondary outcomes will be to assess the hemoglobin variability, proportion of patients achieving hemoglobin increase ≥1 g/dl from baseline and target of 10-12 g/dl at the end of first evaluation period and time to achieve hemoglobin target range. Pharmacokinetic and immunogenicity will also be evaluated in these patients. The total treatment duration may vary depending on the hemoglobin response and dose titrations. 
Close