| CTRI Number |
CTRI/2011/11/002153 [Registered on: 21/11/2011] Trial Registered Prospectively |
| Last Modified On: |
07/01/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to assess the safety of new erythropoietin in chronic kidney disease
patients on Haemodialysis. |
|
Scientific Title of Study
|
A phase I/II, open label, single escalating dose study to assess safety, pharmacodynamics, pharmacokinetics and immunogenicity of polysialylated erythropoietin administered intravenously in chronic kidney disease patients who are on haemodialysis. |
| Trial Acronym |
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Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| PSAEPO: 01/11 Version 5.0 |
Protocol Number |
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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 |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Sajjad Desai |
| Designation |
Deputy Director |
| Affiliation |
Serum Institute of India Pvt. Ltd. |
| Address |
Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla road, Hadapsar, Pune
MAHARASHTRA, India
Pune
MAHARASHTRA
411028
India |
| Phone |
020-26602781 |
| Fax |
020-26993945 |
| Email |
sajjad.desai@seruminstitute.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sajjad Desai |
| Designation |
Deputy Director |
| Affiliation |
Serum Institute of India Pvt. Ltd. |
| Address |
Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla road, Hadapsar, Pune
MAHARASHTRA, India
Pune
MAHARASHTRA
411028
India |
| Phone |
020-26602781 |
| Fax |
020-26993945 |
| Email |
sajjad.desai@seruminstitute.com |
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Source of Monetary or Material Support
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| Serum Institute of India Ltd |
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Primary Sponsor
Modification(s)
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| Name |
Serum Institute of India Pvt Ltd |
| Address |
212/2, Off Soli Poonawalla road, Hadapsar,
Pune 411028,MAHARASHTRA, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
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| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Dewan |
Ajantha Research Centre |
Ajanta Research Centre,
Ajanta Hospital and IVF Centre,
765, ABC Complex, Kanpur R
Alambagh, Lucknow - 226 005
Lucknow
UTTAR PRADESH |
9936507362
0522-4101017
drdeepakdewan@rediffmail.com |
| Dr Mahesh C |
Chaya Hospital |
Chaya Hospital, No. 6C-335, 4th C Main Road, 6th Cross, OMBR Layout, Bhuvanagiri, Bangalore-560043, Karnataka.
Bangalore
KARNATAKA |
080-25284187
doccm2000@yahoo.com |
| Dr Charulata Bawankule |
Government Medical College and Hospital |
Super speciality hospital,
Government Medical College & Hospital
Tukdoji Square, Nagpur 440009
Nagpur
MAHARASHTRA |
9823130707
pk52kule@yahoo.com |
| Dr Satish Balan |
Kerala Institute of Medical Sciences |
Kerala Institute of Medical Sciences,
P B No. 01, Anayara P O, Trivendrum-695029, Kerala.
Thiruvananthapuram
KERALA |
0471-3041406
balansatish@rediffmail.com |
| Dr Georgi Abraham |
Madras Medical Mission |
Madras Medical Mission,
No. 4 A, Dr J J Nagar, Mogappair, Chennai,
Chennai
TAMIL NADU |
04426565961
abraham_georgi@yahoo.com |
| Dr Avinash Ignatius |
Noble Hospital |
Noble Hospital,
153, Magarpatta City Road, Pune 411013
Pune
MAHARASHTRA |
9823101982
dr_ignatius@yahoo.co.in |
| Dr Abhay Gopal Huprikar |
Ruby Hall Clinic |
Grant Medical Foundation, Ruby Hall Clinic, 40, Sassoon Road, Pune 411001
Pune
MAHARASHTRA |
9822027023
abhayhuprikar@gmail.com |
| Dr Deodatta Chafekar |
Shatabdi Super Speciality Hospital |
Shatabdi Super speciality hospital,
Sujoyit square, Mumbai Naka,
Nasik-42205
Nashik
MAHARASHTRA |
02532313788
nchafy@hotmail.com |
| Dr Apurva Parekh |
Shrushrut Clinical Research Association |
4th Floor, Shrushrut Clinical Research Association, Kidney Diseases and Transplant
Foundation, Shubham Superspeciality Hospital, Opp. Bank of Baroda, Near Sardar Patel Statue, Sardar Patel colony. Naranpura, Ahmedabad-380013,
Gujarat,India
Ahmadabad
GUJARAT |
079-30179017
079-30179517
drapoorva@hotmail.com |
| Dr Hansraj Alva |
Vinaya Hospital & Research Centre |
Vinaya Hospital & Research Centre, Department of Medicine, Consulting Physician, Medical Director,
PO Box 717, Karangalpady,
Mangalore – 575003,
Karnataka, India
Dakshina Kannada
KARNATAKA |
91-9343562622
drhansrajalva@yahoo.com |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Astha Independent Ethics Committee |
Approved |
| Ethics Committee Poona Medical College Foundation |
Approved |
| IEC-ARC Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Govt. Medical College Nagpur |
Approved |
| Institutional Ethics Committee The Madras Medical Mission |
Approved |
| Institutional Human Ethical Committee Kerala Institute of Medical Sciences |
Approved |
| Mallikatta Ethics Committee |
Approved |
| Medisys Clinisearch Ethical Review Board |
Approved |
| Noble Hospital Institutional Ethics Committee |
Approved |
| Shatabdi Hospital Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Patients with chronic kidney disease who are on haemodialysis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Polysialylated Erythropoietin |
Polysialylated erythropoietin formulation, which is a performance-enhanced polysialylated form of erythropoietin. It is being developed for the treatment of anaemia in patients who are on dialysis.
Polysialylated erythropoietin will be administered intravenously. Study drug will be administered one time on Day I and subject will be followed through Day 28. |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects willing to give voluntary written informed consent.
2. Males ≥ 18 and ≤ 70 years of age and post-menopausal Females ≤ 70 years of age.
3. Clinically stable on hemodialysis for ≥ 3 months before screening (3 sessions per week).
4. Subjects with adequate dialysis ( as determined by Kt/V≥1.2 or URR≥65%) before enrollment.
5. Hemoglobin value of ≥8g/dL and ≤ 11 g/dL within 14 days prior to administration of study drug
6. Serum ferritin level ≥ 200 µg/L and transferrin saturation ≥ 20% within 14 days prior to administration of study drug
7. RBC folate level and Vitamin B12 level above the lower limit of normal within 14 days prior to administration of study drug. |
|
| ExclusionCriteria |
| Details |
1. Has received erythropoiesis stimulating agent in the last 6 weeks.
2. Blood transfusions within 4 weeks before screening or during the screening period or anticipated blood transfusion within one month after start of the study.
3. Nonrenal causes of anemia (e.g., Hemoglobinopathy [e.g., homozygous sickle cell disease, thalassemia of all types] , hemolysis, vitamin B12 or folic acid deficiency)
4. History suggestive of pure red cell aplasia (PRCA)
5. C Reactive Protein (CRP) greater than 15 mg/dL within 14 days prior to administration of study drug
6. Secondary hyperparathyroidism as evaluated by serum parathormone (PTH) level greater than 800pg/ml at screening.
7. Poorly controlled hypertension within 4 weeks prior to study drug administration, as per Investigators clinical judgment (e.g. systolic ≥ 170 mm Hg, diastolic ≥ 100 mm Hg on repeat readings)
8. Known intolerance to parenteral iron supplementation |
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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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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Assessment of Safety (Vital signs, physical examination & ECG, Monitoring of adverse events, Clinical laboratory assessments) of polysialylated erythropoietin administered through IV route. |
On Day 1, Day 7, Day 14 and Day 28 post dose. |
|
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Secondary Outcome
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| Outcome |
TimePoints |
1. Pharmacokinetic Endpoints
Cmax, Tmax, AUC0-t, AUC0-∞, t1/2 and Kel
2. Pharmacodynamic Endpoints
• Absolute & percent Reticulocyte count
• Reticulocyte hemoglobin(CHr)
• Haemoglobin,
• RBC count
• Hematocrit
3. Immunogenicity Endpoints
• Anti-polysialylated erythropoietin antibodies
• Anti-erythropoietin antibodies
• Anti-polysialic acid antibodies. |
Pharmacokinetics : Pre-dose and 0.25, 1, 2,6,24, 48, 72, 96, 168, 240, 336, 504 and 672 hours post-dose.
Pharmacodynamics:
Pre-dose and 24, 48, 72, 96, 168, 240, 336, 504 and 672 hours post-dose.
Immunogenicity:
Pre-dose and on Day 28 post-dose. |
|
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Target Sample Size
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Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
|
Phase 1/ Phase 2 |
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Date of First Enrollment (India)
|
20/12/2011 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
Nil |
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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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A Phase I/II, Open label, Single escalating dose study to assess safety, pharmacodynamics, pharmacokinetics and immunogenicity of polysialylated erythropoietin administered intravenously in 40 hemodialysis patients. Four intravenous doses of polysialylated erythropoietin (0.5 mcg/kg, 1.5 mcg/kg, 3.0 mcg/kg and 4.5 mcg/kg body weight) are planned to be investigated. Forty subjects will be enrolled into the study in four cohorts of ten subjects each. All subjects will be followed up for a period of 28 days to assess safety, pharmacodynamics, pharmacokinetics and immunogenicity of polysialylated erythropoietin. |