| CTRI Number |
CTRI/2009/091/000452 [Registered on: 15/10/2010] |
| Last Modified On: |
05/08/2016 |
| 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 two weekly for treating the chronic renal anaemia in dialysis patients who are not receiving ESA treatment currently |
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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 two weekly administration of intravenous MIRCERA for the treatment of chronic renal anaemia in dialysis patients not currently treated with ESA |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| ML21822 |
Protocol Number |
| NCT00737711 |
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
Modification(s)
|
| Name |
Dr Binay Sawrup |
| Designation |
Associate Director-Medical Affairs |
| Affiliation |
Roche Products (India) Pvt. Ltd. |
| Address |
Roche Products (India) Pvt. Ltd.
165, Dr. Annie Besant Road,
Mumbai
MAHARASHTRA
400018
India |
| Phone |
912224941414 |
| Fax |
912224949500 |
| Email |
binay.swarup@roche.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Aditi Parekh |
| Designation |
Associate Director-Clinical Operations |
| Affiliation |
Roche Products (India) Pvt. Ltd. |
| Address |
Roche Products (India) Pvt. Ltd.
165, Dr. Annie Besant Road,
Mumbai
MAHARASHTRA
400018
India |
| Phone |
912224941414 |
| Fax |
912224949500 |
| Email |
aditi.parekh@roche.com |
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Source of Monetary or Material Support
Modification(s)
|
| Roche Products (India) Pvt. Ltd.
​1503, 15th Floor, "The Capital",
Plot No. C-70, Behind ICICI Bank,
Bandra Kurla Complex, Bandra (E),
Mumbai 400 051 |
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Primary Sponsor
Modification(s)
|
| Name |
Roche Products India Pvt Ltd India |
| Address |
​1503, 15th Floor, "The Capital",
Plot No. C-70, Behind ICICI Bank,
Bandra Kurla Complex, Bandra (E),
Mumbai 400 051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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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 = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Bharat Shah |
Anil Clinic |
,-
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| Dr. Deepak S. Ray |
Armenian Church Trauma Center |
,-
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| Dr. C.M. Thiagarajan |
Chettinad Hospital And Research Institute |
,-
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| Dr. George T. John |
Christian Medical College |
,-
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| Dr. Rajan Isaacs |
Deep Kidney Care, |
Opp. Deep Hospital, ,Model Town -
Ludhiana
PUNJAB |
0161-5069190
rajan_isaacs@hotmail.com |
| Dr. Sonal Dalal |
Gujrat Kidney Foundation |
,-
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| Dr. Bhupendra Gandhi |
Jaslok Hospital and Research Center |
,-
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| Dr. Ravi Raju |
King George Hospital |
,-
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| Dr. Vivek Pathak |
Kovai Medical Center and Hospital |
,-
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| Dr. Dinesh Mittal |
Maharaja Agrasain Hospital |
,-
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| Dr. Ratan Jha |
Medwin Hospital |
,-
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| Dr. M. M. Rajapurkar |
Muljibhai Patel Urological Hospital |
,-
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| Dr. Sanjiv Saxena |
Pushpawati Singhania Research Institute |
,-
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| Dr. Georgy Nainan |
PVS Memorial Hospital |
,-
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| Dr. D.S. Rana |
Sir Ganga Ram Hospital |
,-
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| Dr. Gokulnath |
St. John's Hospital, Department of Nephrology |
,-
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Details of Ethics Committee
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| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Alert EC-Independent Ethics Committee, Thane |
Approved |
| Ethical Committee, Maharaja Agrasen Hospital, New Delhi |
Approved |
| Ethics Committee, Jaslok Hospital, Mumbai |
Approved |
| Ethics Committee, Muljibhai Patel Society for Research in Nephrology-Urology |
Approved |
| Ethics Committee, Pushpawati Singhania Research Institute for Liver, Renal & Digestive Disease, New Delhi |
Approved |
| Ethics Committee, Sir Ganga Ram Hospital, New Delhi |
Approved |
| Gujarat Kidney Foundation Ethical Committee, Ahmedabad |
Approved |
| Institutional Ethics Committee, Chettinad Hospital And Research Institute, Kanchipuran Dist, Chennai |
Approved |
| Institutional Ethics Committee, King George Ethics Committee, Vishakhapatnam |
Approved |
| Institutional Ethics Committee, Medwin Hospitals, Hyderabad |
Approved |
| Institutional Ethics Committee, Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata |
Approved |
| Institutional Reveiw Board (IRB), Christian Medical College, Vellore |
Approved |
| KMCH Ethics Committee, Kovai medical Center And Hospital Limited, Coimbatore |
Approved |
| PVS Memorial Hospital Ethics Committee, Kaloor, Cochin - 682 017 |
Approved |
| St. John's Medical College Hospital Institutional Ethical Reveiw Board |
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
|
| Type |
Name |
Details |
| Intervention |
MIRCERA |
0.6 mcg/kg body weight at the frequency of once in 15 days |
| 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 8 g/dL and 10 g/dL
? No prior ESA therapy during the previous 2 months
? Adequate iron status (serum ferritin >100 ng/mL AND TSAT>20% OR hypochromic red cells <10%)
? Haemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least the previous 4 Weeks
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| ExclusionCriteria |
| Details |
? Blood transfusion during the previous 4 Weeks
? Poorly controlled hypertension, i.e. sitting blood pressure exceeding 170/100 mm of Hg despite medication. Average of 2 values measured at least two hours apart before dialysis
? Significant acute or chronic bleeding such as overt gastrointestinal bleeding
? Active malignant disease (except non-melanoma skin cancer)
? 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
? Folic acid deficiency, uncorrected in past 2 months
? 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
? Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
? 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
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| To assess effectiveness of two-weekly intravenous administration of MIRCERA in dialysis patients with chronic renal anaemia, not currently treated with ESA. |
? Mean change in Hb concentration from baseline (week 0) and last visit (week 16) of the TP |
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Secondary Outcome
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| Outcome |
TimePoints |
| To evaluate the safety and tolerability of MIRCERA two weekly dosing in the treatment of anaemia in patients with chronic kidney disease. |
? Time to achievement of response (achievement of Hb levels within target range i.e. 10.0 ? 12.0 g/dL)
? The percentage of patients whose average Hb concentration is within the range 10.0 ? 12.0 g/dL in the last 4 weeks of TP
? Mean time spent in Hb range of 10.0 ? 12.0 g/dL during the last 4 weeks of TP
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Target Sample Size
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Total Sample Size="220"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
04/07/2008 |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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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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