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CTRI Number  CTRI/2010/091/000652 [Registered on: 20/07/2010]
Last Modified On: 20/05/2019
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Study to evaluate the efficacy and safety of folic acid plus cyanocobalamin plus pyridoxine as an adjuvant to Recombinant Human Epoetin Alpha (r-HuEPO) therapy in patients with anaemia of End stage renal disease (ESRD).  
Scientific Title of Study   A multicentre, prospective, randomized, study to evaluate the efficacy and safety of folic acid 2.5mg plus cyanocobalamin 2 mg plus pyridoxine (B6) 25 mg as an adjuvant to Recombinant Human Epoetin Alpha (r-HuEPO) therapy in patients with anaemia of End stage renal disease (ESRD).  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Narendra Dedhia 
Designation   
Affiliation   
Address  Parakh Hospital, Khokhani Lane
Opposite to Ghatkopar Railway station, Ghatkopar(E)
Mumbai
MAHARASHTRA
400077
India 
Phone  022-25157000  
Fax    
Email  ndedhia@parakhhospital.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. R.H. Jani 
Designation   
Affiliation  Cadila Healthcare Limited 
Address  Zydus Cadila House
Plot No. 360, TPS 5, Service Road, Vile Parle (East)
Mumbai
MAHARASHTRA
400057
India 
Phone  22-26186057   
Fax    
Email  rhjani@zyduscadila.com  
 
Details of Contact Person
Public Query  
Name  Dr. R.H. Jani 
Designation   
Affiliation   
Address  Zydus Cadila House
Plot No. 360, TPS 5, Service Road, Vile Parle (East)
Mumbai
MAHARASHTRA
400057
India 
Phone  22-26186057   
Fax    
Email  rhjani@zyduscadila.com  
 
Source of Monetary or Material Support  
Cadila Healthcare Limited 
 
Primary Sponsor  
Name  Dr Narendra Dedhia Parakh Hospital Ghatkopar(E) Mumbai - 400 077, Maharashtra 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Cadila Healthacre Limited Zydus Tower Satellite Cross Rd Ahmedabad Gujarat   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudhir Kulkarni  MGM Medical College  N-6 CIDCO,-431003

 		 9422713691

sudhir_aur@sancharnet.in 
Dr Narendra Dedhia  Parakh Hospital  Khokhani Lane, Opp. Ghatkopar Station,Ghatkopar (E)-400077
Mumbai
MAHARASHTRA 		 022-25157000

ndedhia@parakhhospital.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
MGM Medical College Ethics Committee  Submittted/Under Review 
Pioneer Ehtics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D631||Anemia in chronic kidney disease, Anemia of End stage renal disease (ESRD),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arm 1: MCV > 105 fL - Folic acid 2.5mg plus cyanocobalamin (B12)2 mg plus pyridoxine (B6) 25 mg   Three Times Daily (TDS) Oral 
Intervention  Arm 2: MCV< 105 fL - Folic acid 2.5mg plus cyanocobalamin (B12)2 mg plus pyridoxine (B6) 25 mg   Three Times Daily (TDS) Oral 
Comparator Agent  Arm 3: No treatment  NA 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1. Age 18 years and above 2. Subjects of either gender, males or females 3. Subject has given informed consent for participation in this trial. 4. Medically stable CRF patients. 5. Subject on stable EPO alpha therapy for at least 6 weeks at the time of enrolment. 6. Haemoglobin level &#8805; 8 g/dL and &#8804;11g/dl 7. Given written informed consent for participating in the trial.  
 
ExclusionCriteria 
Details  1. Pregnant and nursing mothers 2. Subjects with history of macrocytic anemia secondary to liver disorder (ALT/AST > 2.5 times UNL or bilirubin > 2 times UNL), hypothyroidism and bone marrow disorders 3. Subjects with iron deficiency anaemia (Defined as serum ferritin levels &#8804; 100 &#956;g/L, TSAT &#8804; 20% and peripheral smear picture suggestive of iron deficiency anaemia) 4. Subject on treatment with any of the study drug component. (i.e. folic acid, cyanocobalamin or pyridoxine (B6)), in such case wash out of 1 week will be necessary. 5. Subjects with history of sickle cell anemia, thalassemia or any other hemoglobinopathies. 6. Subjects with history of any significant medical disorder other than ESRD. 7. Subjects with history of malabsorption syndrome, sprue, fish tapeworm infection, pancreatitis and myeloproliferative disorders. 8. Subjects with history of gastrectomy, surgical blind loops or severe abnormalities in the terminal ileum, ileal resection, regional ileitis or intestinal lymphoma. 9. Subjects expected to receive blood transfusion in next 3 months. 10. Subjects with history of alcohol consumption > than 20 gm/week. 11. Subjects who are unwilling or unable to give informed consent.  
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in Mean Haemoglobin level  8/12 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1) Red blood cell indices ( MCV, MCH, MCHC, RDW)  12 Weeks 
2) Serum vitamin B12 assay   12 Weeks 
3) RBC folate assay   12 Weeks 
4) Serum homocysteine  12 Weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="" 
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   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/07/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is an interventional, prospective, randomized, observational study to evaluate the safety and efficacy of folic acid 2.5mg plus cyanocobalamin 2 mg plus pyridoxine (B6) 25 mg as adjuvant to Recombinant Human Epoetin Alpha (r-HuEPO) therapy in anaemia of End stage renal disease as compared to only r-HuEPO therapy. 
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