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
- Conditions
- Health Condition 1: null- Anemic Patients with Chronic Kidney disease on Hemodialysis
- Registration Number
- CTRI/2013/01/003325
- Lead Sponsor
- OK BETA PHARMACEUTICALS I PVT LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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
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 Ð?, 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary-Average dose of the test product (IU/kg) for the last 4 weeks of treatment; <br/ ><br>Average Hemoglobin index for the last 4 weeks of treatment. <br/ ><br>Average Hemoglobin index for the last 4 weeks of treatment. <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: administered intravenously (over 1-5minutes) on Day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, 40, 43, 45, 47, 50, 52, 54, 57, 59, 61, 64, 66, 68, 71, 73, 75, 78, 80, 82, 85, 87, 89, 92, 94, 96, 99, 101, 103, 106, 108, 110, 113, 115, 117, 120, 122, 124, 127, 129, 131, 134, 136, 138, 141, 143, 145, 148, 150, 152, 155, 157, 159, 162, 164, 166 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Relative quantity of patients (%), Hemoglobin index of which was within 110±10 g/L for, at least, last two weeks of observation; <br/ ><br>â?¢Hemoglobin dynamics for the whole period of patientâ??s participation in the trial; <br/ ><br>â?¢Average index of hemoglobin for each four-week period of treatment; <br/ ><br>â?¢Average hematocrit index for each four-week period of treatment; <br/ ><br>â?¢Relative quantity of patients with hemoglobin increment 10-20 g/L for each four-week period. <br/ ><br>Timepoint: administered intravenously (over 1-5minutes) on Day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, 40, 43, 45, 47, 50, 52, 54, 57, 59, 61, 64, 66, 68, 71, 73, 75, 78, 80, 82, 85, 87, 89, 92, 94, 96, 99, 101, 103, 106, 108, 110, 113, 115, 117, 120, 122, 124, 127, 129, 131, 134, 136, 138, 141, 143, 145, 148, 150, 152, 155, 157, 159, 162, 164, 166