Treatment of anaemia in chronic renal failure patients MedDRA version: 8.0 Level: LLT Classification code 10054353
Conditions
Sponsors
BioGeneriX AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: There are only two formal inclusion criteria to be fulfilled at the enrolment visit (Visit 1): 1. Patients who have completed according to protocol the “Correction phase study - subcutaneous” or the “Maintenance phase study - subcutaneous” can enter this trial. 2. Patients must have signed and dated written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: There are no formal exclusion criteria at Visit 1. However, patients presenting at visit 7 with any of the following will not be randomised: 1. Serum ferritin =100 µg/L or TSAT =20%. 2. Patients with active bleeding. 3. Red blood cell transfusion within the last four weeks. 4. Uncontrolled severe hypertension defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg 5. Tertiary or poorly controlled secondary hyperparathyroidism defined as intact parathyroid hormone (PTH) = 10 times the ULN. 6. Current malignant disease. 7. Current systemic infection or inflammatory disease. 8. Known positive test for human immunodeficiency virus (HIV) antibodies. 9. Concomitant therapy with immunosuppressive drugs, steroids (oral or intravenous) or androgens. 10. Patients with resistance to Epoetin (more than 300 IU/kg body weight/week). 11. Planned travel activities outside the participating countries during the final 12 weeks of the study (week 25-36). Under no circumstances may patients be enrolled into this study more than once.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to demonstrate confirmatory therapeutic equivalence of XM01 administered once-weekly compared to thrice-weekly regarding the time-adjusted AUC-Hb and after verification of the therapeutic equivalence to demonstrate the mean weekly dose equivalence between once-weekly and thrice-weekly administration of XM01.;Secondary Objective: Efficacy: The secondary objectives for efficacy are set to compare the efficacy of XM01 administered once-weekly with thrice-weekly during the efficacy evaluation period (week 25 to week 36, 12 weeks) with respect to the following endpoints to be determined during the evaluation period: • Percentage of patients with dose changes (increases, decreases). • Number of dose changes per patient (increases, decreases). • Percentage of haemoglobin values per patient within the target interval (both, 9.5 to 12.0 g/dL and individual baseline value ±1.0 g/dL, determined prior to randomisation). • Percentage of patients with haemoglobin values within the therapeutic range (9.5 to 12.0 g/dL). • Within-patient variance in haemoglobin levels. • Measured values of haemoglobin, haematocrit and reticulocytes. • Number of patients with blood transfusions. Safety The secondary objectives for safety are set to compare safety and tolerability (week 1-36) of XM01. ;Primary end point(s): The primary endpoints are efficacy parameters which are set to demonstrate therapeutic equivalence between once-weekly administration of XM01 and thrice-weekly administration of XM01 (by applying the individual, total weekly dose) during the efficacy evaluation period (week 25 to week 36, 12 weeks) as measured in the • time-adjusted area under the curve for haemoglobin (AUC-Hb) (primary endpoint) and the • mean weekly XM01 dose per kg of body weight (co-primary endpoint). | — |
Countries
Hungary
Outcome results
None listed