| CTRI Number |
CTRI/2010/091/000064 [Registered on: 29/01/2010] |
| Last Modified On: |
30/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Biological |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A clinical trial to evaluate efficacy and safety of Relipoietin in patients with anemia due to Kidney disease |
Scientific Title of Study
Modification(s)
|
Prospective, Multicentric, Open-label, Study to determine the Safety and Efficacy of ReliPoietin when given intravenously to Patients of CKD (Chronic Kidney Disease) with Anemia |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| RLS/TP/2009/03 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Parvez Kosgi |
| Designation |
Head RLS Clinical Trial |
| Affiliation |
Reliance Life Sciences Pvt. Ltd. |
| Address |
Reliance Life Sciences Pvt Ltd,
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
02240678000 |
| Fax |
02240678299 |
| Email |
parvez.kosgi@relbio.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Devi Manjula |
| Designation |
Medical Monitor |
| Affiliation |
Reliance Life Sciences Pvt. Ltd. |
| Address |
CPR TOWERS, # 65-373-2, 100 ft. Ring Road,BTM Layout 2nd Stage Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
08066261116 |
| Fax |
08066261275 |
| Email |
devi.manjula@relbio.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Parvez Kosgi |
| Designation |
Head RLS Clinical Trial |
| Affiliation |
Reliance Life Sciences Pvt. Ltd |
| Address |
Reliance Life Sciences Pvt Ltd,
Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
02267678000 |
| Fax |
02267678299 |
| Email |
parvez.kosgi@relbio.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Reliance Life sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701. India |
|
Primary Sponsor
Modification(s)
|
| Name |
Reliance Life Sciences Pvt Ltd |
| Address |
Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701. India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jagdeep Shah |
Gujarat Kidney Foundation |
4 & 5th Floor, Shaival Complex, Mahalaxmi Char Rasta, Paldi, Ahmedabad
Ahmadabad
GUJARAT |
9825071369
drjagdeepshah@yahoo.com |
| Dr. B. R. Ramesh Rao |
Sanjeevani Kidney Care |
Nitya Priya Society, Sahar road, Near Andheri Station (East),,-40069
Mumbai
MAHARASHTRA |
drramesh.rao@gmail.com |
| Dr. Georgy Abraham |
Tanker Foundation |
766, PH Road, Kilpauk,-400069
Chennai
TAMIL NADU |
tanker1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| EC, Tanker Foundation |
Approved |
| Ethics RUs |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients with Chronic Kidney Disease, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
ReliPoietin |
Dose: 10,000 IU,
Frequency: once in a week
Route of Administration: for 8 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Hb levels between 7 & 10g/dL (both inclusive).
2. Patients with chronic kidney disease
3. Patients with a therapeutic indication for treatment of anemia, after correction of
anemia secondary to iron, folate or B12 deficiency (Transferrin saturation > 20%,
Serum Ferritin > 100ng/ml)
4. Women of child bearing potential having a negative pregnancy test and taking
adequate birth control measures/documented to be postmenopausal
5. Able to comprehend and willing to give informed consent for the study and willing
to come for follow up visit as per protocol requirement. If the subject is illiterate,
then the consent will be taken in the presence of impartial witness. |
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled hypertension ≥180/100 at screening
2. Patients with h/o blood clotting abnormalities
3. Patients with micro or macrocytosis (mean corpuscular volume 72 or 110 μm3)
4. Treatment for any infection with drugs known to affect erythropoiesis, including
androgens and angiotensin-converting enzyme (ACE) inhibitors.
5. Patients with known history of allergy to mammalian cell derived products
6. Patients with known history of allergy to human serum albumin
7. Inclusion to any other clinical trial within previous 28 days
8. Patients who are known hypersensitive to rHu-EPO
9. Patients with history of anemia due to causes other than anemia of CKD,
abnormal parathyroid hormone levels
10. Patients with history of Active infections, Hemoglobinopathies, Neoplastic
diseases
11. Patients with HIV infection
12. Patients with Known history of G.I. bleeding
13. Patients with history of serious or unstable medical or psychological conditions
that could compromise the patients safety or successful trial participation
14. Patients with abnormal liver function tests (SGOT2.5 X ULN, SGPT 2.5 X ULN,
Bilirubin 2.5 X ULN, Alkaline Phosphatase 2.5 X ULN). However, patients with
HBsAg and HCV positive can be included provided their transaminases are
normal
15. Pregnant and lactating female patients
16. Patients unwilling or unable to comply with the study procedures.
17. History of Chronic alcoholic or drug abuse patients
18. Patients with other systemic disorders who are not suitable for enrolling into the
study on the discretion of the investigator. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To achieve the rise in Hb in patients of Chronic Kidney Disease with anemia |
8 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. To achieve improvement in hematocrit values
2. To study the safety of ReliPoietin |
8 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
10/05/2010 |
| Date of Study Completion (India) |
25/08/2010 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a Prospective, Multicentric, Open-label, Study to determine the Safety and Efficacy of ReliPoietinTM when given intravenously to Patients of CKD (Chronic Kidney Disease) with Anemia. 75 subjects will be enrolled across multicenters in India. 10,000 IU of ReliPoietinTM will be administered once weekly for 8 weeks. Primary outcome will be the mean rise in Hb from baseline to EOS. Secondary outcome will be the safety of ReliPoietin during study period. Patients will be followed up to week 9. |