Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Comparative study of efficacy and safety of Relipoietin and of medicinal drug Eprex® in the treatment of anemia in patients with chronic kidney
disease on hemodialysis
Scientific Title of Study
A prospective, international, multicenter, open-label, randomized,
comparative study of efficacy and safety of Relipoietin (Reliance Life
Sciences Pvt. Ltd., India) and of medicinal drug Eprex® (Cilag AG,
Switzerland) in the treatment of anemia in patients with chronic kidney
disease on hemodialysis
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
RLS-RP-01, Version No.: 1.0, Dated: 07.02.2012
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pooja Binnani Girdharilal
Designation
Consultant Nephrologist
Affiliation
Bhiwandi Dialysis Centre
Address
Bhiwandi Dialysis Centre,
Opposite Hindustani Masjid, Mandai, Bhiwandi, District: Thane
Bhiwandi Dialysis Centre,
Opposite Hindustani Masjid, Mandai, Bhiwandi, District: Thane.
Maharashtra – India Thane MAHARASHTRA 421308 India
Phone
9833164346
Fax
Email
pooja.binnani@yahoo.com
Details of Contact Person Scientific Query
Name
Dr Amit Bhatt
Designation
President & CEO
Affiliation
NEXUS CLINICAL RESEARCH (INDIA) LTD.
Address
32 A Nexus Center For Clinical Excellence Sector 1, Shiravane Road, Service Industry, Nerul (E), New Mumbai- 400 706 Maharashtra - India
32 A Nexus Center For Clinical Excellence Sector 1, Shiravane Road, Service Industry, Nerul (E), New Mumbai- 400 706 Maharashtra - India
Mumbai (Suburban) MAHARASHTRA 400706 India
Phone
02227714204
Fax
Email
dramit.bhatt@gmail.com
Details of Contact Person Public Query
Name
Dr Amit Bhatt
Designation
President & CEO
Affiliation
NEXUS CLINICAL RESEARCH (INDIA) LTD.
Address
32 A Nexus Center For Clinical Excellence Sector 1, Shiravane Road, Service Industry, Nerul (E), New Mumbai- 400 706 Maharashtra - India
32 A Nexus Center For Clinical Excellence Sector 1, Shiravane Road, Service Industry, Nerul (E), New Mumbai- 400 706 Maharashtra - India
Mumbai (Suburban) MAHARASHTRA 400706 India
Phone
02227714204
Fax
Email
dramit.bhatt@gmail.com
Source of Monetary or Material Support
LOK BETA PHARMACEUTICALS (I) PVT LTD.
324 Corporate Centre, Nirmal Lifestyle,
LBS Road, Mulund (W), Mumbai -80, India
Primary Sponsor
Name
LOK BETA PHARMACEUTICALS I PVT LTD
Address
LOK BETA PHARMACEUTICALS (I) PVT LTD. 324 Corporate Centre, Nirmal Lifestyle, LBS Road, Mulund (W), Mumbai -80, India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India Russian Federation
Sites of Study
No of Sites = 2
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Abhijit K Korane
Aster-Aadhar Hospital
Department of Nephrology Aster-Aadhar
Hospital
R.S. No. 628, ‘B’ ward, Near Shastri Nagar,
KMT Workshop, Kolhapur-416012,
Maharashtra – India Kolhapur MAHARASHTRA
Anemic Patients with Chronic Kidney disease on Hemodialysis,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Eprex® (Cilag AG, Switzerland)
Trade name: Eprex®
International Nonproprietary Name: Epoetin Alfa
Dosage form: solution for intravenous and subcutaneous administration.
Composition:
1 ml of solution for intravenous and subcutaneous administration contains:
Active ingredient: Recombinant Epoetin alfa 10 000 IU (336 μg)
Excipients: Polysorbate-80, Sodium Chloride, Sodium Phosphate Dihydrate, Sodium Dihydrogen Phosphate Dihydrate, Glycine, Water for injections for dilution up to 1 ml.
Description:
Clear, colorless solution
Shelf-life: 1.5 years. Do not use after expiry date.
Storage conditions: Store at temperature from 2 to 8°С in protected from light place. Do not shake and freeze. Keep away from children.
Intervention
ReliPoietin (Reliance Life Sciences Pvt. Ltd., India)
Trade name: ReliPoietin
International Nonproprietary Name: Epoetin Alfa
Dosage form: solution for intravenous and subcutaneous administration.
Composition: Recombinant Epoetin Alfa, 10000 IU, Sodium Chloride, Sodium Dihydrogen Phosphate Dihydrate, Sodium Phosphate Dodecahydrate, Glycine, Polysorbate-20, water for injection.
Description: Clear, colorless solution
Shelf-life:1,5
Storage conditions: Store at temperature from 2 to 8°С in protected from light place.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1)Written informed consent.
2)End stage of chronic kidney disease.
3)The need for hemodialysis for at least
the last 3 months before inclusion
in the study.
4)The need for standard hemodialysis with total duration of at least 12 hours per
week.
5)The established efficacy of hemodialysis.
Hemoglobin <110 g/L
6)Transferrin saturation >20%, Ferritin level >100 ng/ml
7) Ability of patient, according to the Investigator, to comply with the
protocol procedures
8)Readiness of patients with preserved
reproductive function to use
reliable methods of contraception
ExclusionCriteria
Details
1)The use of any erythropoiesis-stimulating agents (other erythropoietins, androgens) within 8 weeks prior to study entry.
2)Blood transfusion within four weeks prior to study entry.
3)Any other genesis of anemia, with the
exception of renal (folic acid and B12-deficiency anemia, and other types of
anemia)
4)Anemia of chronic disease (activity of
C-reactive protein> 10 mg / l)
5)Refractory anemia in the presence of
blast transformed cells in peripheral blood
6)Diagnosed lupus nephritis or chronic
kidney disease in patient developed as a consequence of systemic angiitis;
7)Presence of neutralizing antibodies to
erythropoietin.
8)Vaccination within 8 weeks before study entry
9)Hepatic cirrhosis complicated with portal
hypertension, and/or splenomegaly, and/or
ascites
9)HIV-infection, advanced Hepatitis В, С
10)Activity of ALAT, AST > 3ULN
11)Epilepsy (including in past medical history)
12)Obliterative peripheral vascular disease
13)Porphyria
14)Confirmed bone marrow fibrosis
15)Acute decompensated heart failure 16)Uncontrolled hypertension
17)Unstable angina
18)Diagnosed severe secondary hyperparathyroidism
19)Episodes of gastrointestinal bleeding in history
20)Episodes of thrombosis in history (acute
myocardial infarction, stroke,
transient ischemic attacks, deep vein
thrombosis, pulmonary embolism)
within six months prior to study entry, as well
as an increased risk of deep vein thrombosis
21)History of acute hemolytic episodes
22)Abdominal operation within 1 month prior to
study entry
23)Any acute inflammatory disease or
exacerbation of chronic diseases,
including identified foci of septic and aseptic
inflammation
24)Malignancy, except cured basal cell carcinoma
and cervical cancer in situ; any malignancy
with a duration of complete remission for more
than 5 years
25)Drug addiction, alcohol abuse
26)Hypersensitivity to Epoietin alpha or to
any components of study drugs
27)Pregnancy or lactation
28)Simultaneous participation in other clinical trials, and prior participation in other clinical trials within 3 months before inclusion in this clinical study
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Primary-Average dose of the test product (IU/kg) for the last 4 weeks of treatment;
Average Hemoglobin index for the last 4 weeks of treatment.
Average Hemoglobin index for the last 4 weeks of treatment.
Relative quantity of patients (%), Hemoglobin index of which was within 110±10 g/L for, at least, last two weeks of observation;
•Hemoglobin dynamics for the whole period of patient’s participation in the trial;
•Average index of hemoglobin for each four-week period of treatment;
•Average hematocrit index for each four-week period of treatment;
•Relative quantity of patients with hemoglobin increment 10-20 g/L for each four-week period.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Today effective and safe treatment of anemia in patients with chronic
renal failure and requiring dialysis is a serious social and medical problem.
Direct damage
to the renal parenchyma, leading to the violation of the endogenous
erythropoietin production conditions the fact of anemia of varying severity in
all patients with chronic kidney disease. Thus, almost in 90% of patients with
chronic renal failure hemoglobin is less than 100 g/L. According to modern
Russian and European guidelines treatment of anemia with chronic kidney disease
and hemoglobin index less than 110 g/L requires the administration of
erythropoiesis-stimulating agents.
A new stage in the treatment of symptomatic anemia was the use of drugs,
similar in structure and action to endogenous erythropoietin - Recombinant Erythropoietin
(Epoetin). Until that time, the only way to treat anemia resulting from chronic
kidney disease were blood transfusions, the performance of which is associated
with a known risk.
ReliPoietin - Recombinant Epoetin Alfa. In the conducted
clinical studies of early phases it showed its similarity to the original drug Epoetin
Alfa, Eprex in terms of pharmacokinetic and pharmacodynamic properties. This
study is designed to demonstrate therapeutic equivalence to the original drug.