Chronic renal failure induces a progressive decline of the kidney function that leads to end stage renal disease (ESRD). The end stage is reached when the glomerular filtration rate decreases to < 5 mL/minute. In patients with chronic renal failure the production of hormones such as erythropoietin is disturbed. Anemia is present in the majority of patients with chronic renal failure. This anemia is usually caused by erythropoietin deficiency (although other factors can contribute)
Conditions
Interventions
Product Name: Epoietin (Pliva)
Pharmaceutical Form: Solution for injection
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000-
Trade Name: EPREX
Product
Sponsors
PLIVA Research and Development Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have chronic renal failure requiring regular hemodialysis, and receiving at least 6 months r HuEPO treatment (75 300 international units [IU]/kg per week either iv or subcutaneous) of which at least 3 months should be r-HUEPO maintenance therapy, prior to the Screening Visit. 2. The hemodialysis is of adequate quality, defined as fractional urea clearance (Kt/Vurea) ³ 1.2 (within the 4 weeks prior to the Screening Visit). 3. Have controlled Hb level of 10 to 13 g/dL during the last 8 weeks prior to the Screening Visit (mean value of 3 measurements 10-13 g/dL, difference between highest and lowest value no more than 2 g/dL, measurements at least 1 week apart). Be on stable dose of epoetin, i.e., no dose change during the last 8 weeks of r-HUEPO treatment. 4. Are clinically stable (based on the investigator’s judgment) within the 3 months prior to the Screening Visit. 5. Have adequate iron stores (serum ferritin > 100 mg/L and TfS > 20%) at the Screening Visit. Patients who meet all other criteria will be given iron therapy and be re-screened after 2 weeks. All study assements of the screening visit (exept for written informed consent; demographics/medical history, serology; vitamin B12 and folic acid) must be repeated as soon as the time between the screening and first dosing exeeds 2 weeks (+ 3 day window). The type of iron therapy chosen will be at the discretion of the investigator, and according to local requirements. 6. Are aged 18 to 75 years. 7. Females of childbearing potential must have a negative serum pregnancy test at screening and be practicing an acceptable method of birth control during the study and for up to 1 month after the last dose of the study drug. Acceptable methods (which have a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have had treatment with long-acting epoetin analogues, such as Aranesp, or are receiving maintenance does of r-HuEPO >300 IU/kg per week. 2. Have had treatment for epilepsy with tonic clonic seizures within 6 months prior to the Screening Visit. 3. Have congestive heart failure (New York Heart Association [NYHA] class III or IV). 4. Have had a cerebrovascular accident, myocardial infarction, coronary angioplasty or bypass surgery within 6 months prior to the Screening Visit. 5. Have uncontrolled hypertension, defined as 2 diastolic blood pressure measurements > 110 mmHg, and/or 2 systolic measurements > 180 mmHg, taken after dialysis within the 4 weeks prior to the Screening Visit. If one blood pressure measurement is increased above limits, another measurement will be taken after a 30 minute interval for confirmation. 6. Have had major surgery within 3 months prior to the Screening Visit (excluding vascular access surgery). 7. Have active inflammatory or malignant disease. 8. Have been previously diagnosed with human immunodeficiency virus (HIV) or chronic hepatitis B or C virus infection. Patients who are hepatitis B surface antigen (HbsAg) or hepatitis C virus antibody (anti HCV) positive can be included if they have normal transaminases and are not on anti viral treatment. 9. Have had a RBC transfusion(s) within 3 months prior to the Screening Visit or during the screening Period, or have chronic bleeding or clinically significant blood loss. 10. Have any anemia with a cause other then chronic renal failure (e.g., hemolytic anemia including sickle cell disease, megaloblastic anemia, aplastic anemia, myelodysplasia, pure red cell aplasia). 11. Are currently enrolled in any other investigational device or drug study, or have participated in another clinical study within 30 days prior to the Screening Visit. 12. Are pregnant women or mothers who are breast feeding. 13. Have a known hypersensitivity (drug intolerance or allergy) to r HuEPO, epoetin alfa (Janssen Cilag), or excipients of epoetin (PLIVA).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate equivalent efficacy of epoetin (PLIVA) compared to epoetin alfa (Janssen Cilag), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements, in patients treated for anemia associated with chronic renal failure.;Secondary Objective: To compare the safety and tolerability of epoetin (PLIVA) with epoetin alfa (Janssen Cilag) in patients treated for anemia associated with chronic renal failure;Primary end point(s): The primary endpoints for this study are: ·The difference in change from baseline (mean of last 2 readings of the open-label treatment period) to the mean of Weeks 26 and 28 (last 2 readings of the double-blind treatment period) in Hb concentration for each treatment ·The percentage change in mean weekly dose of study drugs at baseline (end of the open-label treatment period) to mean weekly dose during the last 4 weeks of the double-blind treatment period (Weeks 24-28) for each treatment Hb response is measured by assessing the combined mean at Weeks 10 and 12 to take into account possible Hb fluctuations. | — |
Countries
Lithuania
Outcome results
None listed