| CTRI Number |
CTRI/2009/091/000455 [Registered on: 20/08/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Single Arm Study |
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Public Title of Study
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A clinical trial to assess the effect, safety and tolerability of MIRCERA administered intravenously or subcutaneously once in a month for the maintainance of Haemoglobin levels in dialysis patients with chronic renal anaemia |
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Scientific Title of Study
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A single arm, open label study to assess the efficacy, safety and tolerability of once-monthly administration of intravenous or subcutaneous MIRCERA for the maintenance of haemoglobin levels in dialysis patients with chronic renal anaemia |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NCT00737464 |
ClinicalTrials.gov |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
Not Applicable
N/A
India |
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
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| Name |
Dr. Anil Kukreja |
| Designation |
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| Affiliation |
Roche Products (India) Pvt. Ltd. |
| Address |
Roche Products (India) Pvt. Ltd.
165, Dr. Annie Besant Road,
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
+91 22 24941414 |
| Fax |
+91 22 24949500 |
| Email |
anil.kukreja@roche.com |
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Details of Contact Person
Public Query
|
| Name |
Dr. Anil Kukreja |
| Designation |
|
| Affiliation |
|
| Address |
Roche Products (India) Pvt. Ltd.
165, Dr. Annie Besant Road,
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
+91 22 24941414 |
| Fax |
+91 22 24949500 |
| Email |
anil.kukreja@roche.com |
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Source of Monetary or Material Support
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| Roche Products (India) Pvt. Ltd. |
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Primary Sponsor
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| Name |
Roche Products (India) Pvt.Ltd, India |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrirang Bichu/Dr Prakash Jadhav |
Apex Kidney Care |
Gaurav Plaza, ,1st Floor, RRT Road, Mulund (W), Mumbai ? 400 080-400 080
Mumbai
MAHARASHTRA |
drprjadhav@yahoo.com |
| Dr. Vijay Kher |
Fortis Flt. Lt. Rajan Dhall Hospital, |
Department of Nephrology and Transplant Medicine, Fortis Flt. Lt. Rajan Dhall Hospital, ,Vasant Kunj, New Delhi - 110 070-110 070
New Delhi
DELHI |
vijay.kher@rediffmail.com |
| Dr. Sanjiv Jasuja |
Indraprastha Apollo Hospitals |
Basement Hostel Complex, Spectra, AHERF, Indraprastha Apollo Hospitals ,Sarita Vihar, Delhi Mathura Road, New Delhi - 110076 (India)-110076
New Delhi
DELHI |
sanjiv_jasuja@hotmail.com |
| Dr. Tonmoy Das |
International Hospital |
C/o Assam Hospital Ltd, ,Lotus Tower, G. S. Road,-781005
|
deka.pranjal@gmail.com |
| Dr. Tarun Kumar |
Kamineni Hospitals Limited |
L.B.Nagar,Hyderabad- 500068, -500068
Hyderabad
ANDHRA PRADESH |
drtksaha@rediffmail.com, ramangrk@gmail.com |
| DR Sunder/ Dr Shailendra Goswami |
KANTI Columbia Asia Medical Centre |
Hebbal,Kirloskar Business Park ,Bellary Road,Hebbal,Bangalore ? 560024-560024
Bangalore
KARNATAKA |
'ssundar99@hotmail.com', Delphi.p9@gmail.com, dewdrops@aol.in |
| Dr. Umesh Khanna |
Lancelot dialysis Center |
Lancelot building, ,S. V. Road, Near Kora Kendra, Borivalli (W), Mumbai ? 400 092.-400 092
Mumbai
MAHARASHTRA |
'miniiarora@gmail.com', miniiarora@yahoo.co.in |
| Georgi Abraham |
Madras Medical Mission Hospital |
4A, Dr. J.J.Nagar, ,Mogappair, Chennai 600037-600037
Chennai
TAMIL NADU |
icvddoctors@mmm.org.in |
| Dr. Sudarshan Ballal |
Manipal Institute of Nephrology & Urology, |
Rustam Bagh,Airport Road, Bangalore 560 017 -560017
Bangalore
KARNATAKA |
shwethav@ecronacunova.com |
| Dr. Pradeep Kumar |
Meerut kidney hospital Pvt. Ltd |
Prabbhat Nagar,,L.I.C. Road, Meerut - 250001-250001
Meerut
UTTAR PRADESH |
nipunrana@gmail.com |
| Dr. Rajan Ravichandran |
MIOT Institute of Nephrology |
MIOT Hospital, No. - 4/112, ,Mount Poonamalee Road, Manapakkam, Chennai - 6000089.-6000089
Chennai
TAMIL NADU |
mion@rediffmail.com |
| Dr. Kaligotla Venkata Dakshinamurty |
Nizam's Institute of Medical Sciences |
Punjagutta,,Hyderabad - 500 082, Andhra Pradesh, India-500 082
Hyderabad
ANDHRA PRADESH |
dakshinamurty_kv@yahoo.com, dr.dakshinamurthy@gmail.com |
| Dr. Nirbhai Kumar |
Regency Hospital Ltd |
Consultant Neprologist, Regency Hospital Ltd. ,A-2.Sarvodya Nagar, Kanpur-208005
|
nirbhai.kidneyclinic@gmail.com |
| Dr. Arjinder Singh Bains |
Silver Oaks Hospital |
Silver Oaks Hospital, Phase IX, Sector 63,S.A.S. Nagar, Mohali - 160 063. Punjab-160 063
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arjinder_chd@dataone.in |
| Georgi Abraham |
TANKER Foundation |
TANKER Foundation,Nungabakkam, Chennai ? 600 034-600 034
Chennai
TAMIL NADU |
tanker1993@hotmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Alert EC IEC, Meerut kidney hospital Pvt. Ltd |
Approved |
| Alert EC IEC,Silver Oaks Hospital |
Approved |
| Alert IEC, Apex Kidney Centre |
Approved |
| Alert IEC, KANTI Columbia Asia Medical Centre |
Approved |
| Alert IEC, Lancelot Dialysis Centre |
Approved |
| Ethics Committee - TANKER foundation |
Approved |
| Ethics Committee For Research, Fortis Flt. Lt. Rajan Dhall Hospital |
Approved |
| Ethics Committee of Manipal Hospital and Manipal Heart Foundation |
Approved |
| Ethics Committee of Nizams Institute of Medical Sciences |
Approved |
| Ethics Committee on Clinical Trials ,Indraprastha Apollo Hospitals |
Approved |
| Ethics Committee, International Hospital |
Approved |
| Institutional Ethics Committee, Kamineni Hospitals Pvt. Ltd., |
Approved |
| Institutional Ethics Committee, Regency Hospital Ltd. |
Approved |
| Institutional Ethics Committee-The Madras Medical Mission Hospital |
Approved |
| Medical Ethics Committee, MIOT Institute of Nephrology, MIOT Hospitals, |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Chronic Renal Anaemia, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
MIRCERA |
Starting dose of MIRCERA Depending upon the previous dose of EPO
1)EPO <8000 IU/week - MIRCERA 120 mcg
2)EPO 8000-16000 IU/week - MIRCERA 200 mcg
3)EPO >16000 IU/week - MIRCERA 360 mcg |
| Comparator Agent |
Nil |
Nil |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
? Written informed consent
? Age 18 years or older
? Chronic renal anaemia
? Haemoglobin concentration between 10.0 g/dl and 12.0 g/dL
? Adequate iron status as judged by Investigator
? Continuous intravenous or subcutaneous maintenance epoetin alfa therapy with the same dosing interval during the previous 2 months
? Regular long-term haemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least the previous 2 months
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| ExclusionCriteria |
| Details |
? Blood transfusion during the previous 1 month
? Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 mm of Hg despite medication requiring hospitalization or interruption of epoetin alfa treatment in the previous 2 months
? Significant acute or chronic bleeding such as overt gastrointestinal bleeding
? Medically significant dialysis inadequacy
? Known malignant disease (except non-melanoma skin cancer)
? Known history of Haemolysis
? History of Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
? Platelet count >500 x 109/L or <100 x 109/L
? History of Pure red cell aplasia
? Known Folic acid deficiency (uncorrected in past 2 months)
? Known Vitamin B12 deficiency (uncorrected in past 2 months)
? Epileptic seizure during previous 6 months
? Congestive heart failure (NYHA Class IV)
? Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during the previous 3 months
? Pregnancy or lactation period
? Women of childbearing potential without effective contraception
? Participation in a clinical trial or receipt of an investigational compound or an investigational treatment during the previous
3 months
? Planned (date) elective surgery during the study period
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| To assess the maintenance of haemoglobin levels, with once-monthly intravenous or subcutaneous administration of MIRCERA in dialysis patients with chronic renal anaemia. |
?The proportion of patients maintaining mean haemoglobin concentration during last 4 weeks of Treatment Period (TP) within the target range i.e. 10.0 ? 12.0g/dL. |
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Secondary Outcome
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| Outcome |
TimePoints |
| To evaluate the safety and tolerability of MIRCERA once monthly in the treatment of anaemia in dialysis patients with chronic kidney disease |
? Change in mean haemoglobin concentration between reference (SVP) and in last 4 weeks of Treatment Period (TP)
? Mean time spent in haemoglobin range of 10.0 -12.0 g/dL |
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Target Sample Size
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Total Sample Size="170"
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" |
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Phase of Trial
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Phase 4 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/08/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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